2025 Guidelines for Fluorescence Image-guided Surgery Using Indocyanine Green in Gastrointestinal Procedures

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Authors

Elisa C Calabrese^1,2,3, Sunjay Kumar⁴, Dena Shehata⁵, Panagiotis Kapsampelis⁶, Stefan Scholz⁷, Maria Rita Rodriguez-Luna⁸, Nisha Narula⁹, Jeffrey Chiu¹⁰, Farah Husain¹¹, Patricia Sylla¹², Guy Maddern^2,3, Subhashini Ayloo¹³, Ziad Awad¹⁴, Bethany J. Slater¹⁵, Deborah S Keller¹⁶

ABSTRACT

Background: Fluorescence image-guided surgery (FIGS) with indocyanine green (ICG) is a surgical adjunct that provides real-time, advanced visualization during surgery. It has been increasingly used in clinical practice for its potential to enhance intraoperative precision and safety. However, evidence to date regarding its utility remains variable. An expert panel was convened to provide evidence-based recommendations on the intraoperative use of FIGS with ICG across several surgical applications to support clinicians and patients in decision-making.

Methodology: A systematic review was carried out, including a literature search up to October 2022, addressing eight key questions regarding FIGS with ICG compared to its absence in various surgical settings and service lines. The findings were subsequently presented to a panel of adult and pediatric surgeons. Subject matter experts then used the GRADE methodology to develop evidence-based recommendations.

Results: Recommendations in favor of using FIGS with ICG were made for detection of non-regional metastases, intra-operative identification of primary cancers, LN identification in GI cancers, and anastomosis quality in esophageal and left-sided colorectal anastomosis. Thoracic duct identification and bariatric and pediatric pull through anastomosis did not have sufficient evidence to make a formal recommendation. Still, the expert consensus agreed that FIGS with ICG is a reasonable option for those surgical applications.

Conclusions: These recommendations guide the use of FIGS with ICG in different surgical areas according to the existing literature and expert input. The panel also highlighted evidence gaps to support future research for a stronger evidence base around FIGS in adult and pediatric gastrointestinal surgery.

Keywords: Fluorescent imaging · Fluorescence image-guided surgery (FIGS) · Indocyanine green (ICG) · Guidelines · Gastrointestinal (GI) surgery

ABBREVIATIONS & ACRONYMS
FIGS – Fluorescence image-guided surgery
ICG – Indocyanine green
GI – Gastrointestinal
RCT – Randomized Controlled Trial
RR – Risk ratio
OR – Odds ratio
CI – Confidence Interval
EtD – Evidence to Decision
GRADE – Grading of recommendations, assessment, development, and evaluations
KQ – Key questions
PICO – Population, intervention, comparison, outcome
SAGES – Society of American Gastrointestinal and Endoscopic Surgeons

EXECUTIVE SUMMARY

Summary of key questions (KQ) and associated recommendations

KQ1: Should the use of ICG versus no ICG be used for intraoperative identification of the thoracic duct?
Recommendation: FIGS with ICG is a reasonable option to assist in the intraoperative identification of the thoracic duct compared with standard methods (expert opinion).

KQ2: Should ICG versus no ICG be used for intra-operative identification of distant (non-regional) cancer metastases?
Recommendation: The panel suggests the use of FIGS with ICG intraoperatively for the detection of distal metastases (conditional recommendation, very low certainty of evidence).
Please note the variability in injection, chemotherapy exposure, tumor type, and ICG dose making this dependent on the patient, pathology and surgeon. ICG is an adjunct tool and does not replace standard surgical assessment methods.

KQ3: Should ICG versus no ICG be used for intraoperative identification of primary cancers?
Recommendation: The panel suggests the use of FIGS with ICG intraoperatively for intraoperative identification of abdominal primary cancers in patients (conditional recommendation, moderate certainty of evidence).
Please note the variability in injection, chemotherapy exposure, tumor type, and ICG dose making this dependent on the patient, pathology and surgeon. ICG is an adjunct tool and does not replace standard surgical assessment methods.

KQ4: Should ICG versus no ICG be used in patients undergoing resection of gastrointestinal cancers for intra-operative identification of lymph nodes?
Recommendation: The panel recommends the use of FIGS with ICG intraoperatively in the identification of lymph nodes for patients undergoing resection for gastro-intestinal cancers (strong recommendation, high certainty of evidence).
Please note that ICG is an adjunct tool and does not replace standard nodal harvest.

KQ5: Should ICG versus no ICG be used prior to per-forming a colorectal anastomosis to improve the quality of the anastomosis?
Recommendation: The panel recommends the use of FIGS with ICG intraoperatively in patients undergoing left-sided colorectal anastomosis for benign or malignant disease to improve the quality of the anastomosis* (strong recommendation, moderate certainty of evidence).
*this recommendation includes patients with a diverting stoma.

KQ6: Should ICG versus no ICG be used prior to per-forming an esophageal anastomosis in patients undergoing resection for esophageal cancer to improve the quality of the anastomosis?
Recommendation: The panel suggests the use of FIGS with ICG when performing esophageal anastomosis in patients undergoing resection of esophageal cancer (conditional recommendation, very low certainty of evidence).
Please note that ICG is an adjunct tool and does not replace standard surgical assessment methods.

KQ7: Should ICG versus no ICG be used prior to performing a gastrointestinal anastomosis in patients undergoing bariatric or revisional bariatric operations to improve the quality of the anastomosis?
Recommendation: FIGS with ICG is a reasonable option to assist in primary or revisional bariatric operations but there is currently not enough evidence to deter-mine this for certain (expert opinion).

KQ8: Should ICG versus no ICG be used in pediatric patients undergoing a pull through to improve the quality of the anastomosis?
Recommendation: FIGS with ICG is a reasonable option to assist in the pediatric pull-through cases as com-pared to standard operative procedure (expert opinion).

Background

Fluorescence image-guided surgery (FIGS) with indocyanine green (ICG) is a surgical adjunct employed across several specialties with varying evidence on its utility. The purpose of this guideline is to provide counsel on the use of FIGS with ICG compared to standard of care across different surgical disciplines. A systematic review was conducted, and published separately, followed by the development of recommendations using a multidisciplinary panel of surgeons to assist clinicians and patients in decision-making surrounding the use of FIGS with ICG.

Interpretation of strong and conditional recommendations

All guideline recommendations were proclaimed as “strong” or “conditional”. The phrase “the guideline panel recommends” is used for strong recommendations, and “the guideline panel suggests” for conditional recommendations, as per the GRADE approach [1, 2]. A conditional recommendation signals that the benefits of adhering to a recommendation probably outweigh the harms but contains uncertainty. This uncertainty may be due to a lack of high-quality evidence or variability in how individual patients value the outcomes of interest.

How to use these guidelines

These guidelines are primarily intended to aid surgeons in the decision to use FIGS with ICG intraoperatively versus the standard of care. They are also made to educate, inform policy and advocacy, and to identify future research needs. Clinical decision making is multifaceted, and these guidelines are intended to suggest, but not mandate, an acceptable approach to surgical management. Finally, these guidelines can also be used by patients as a basis of discussion with their treating surgeon.

INTRODUCTION

Aim of these guidelines

The purpose of this guideline is to provide evidence-based recommendations regarding the utility of fluorescent image-guided surgery (FIGS) with indocyanine green (ICG) across different surgical disciplines. The target audience for this guideline is surgeons, surgical trainees, institutional stakeholders, and patients. Policy makers and insurance providers interested in this guideline include those involved in delivering local, national, and international health care services supporting the comprehensive diagnosis and treatment of pathologies requiring surgical intervention or evaluating the direct and indirect benefits and risks related to FIGS with ICG use as a surgical adjunct. This document may also serve as a resource for adaptation of the technology by local, regional or national guideline panels.

Description of the health problem

FIGS with ICG allows for a real-time operative adjunct to assist in critical structures and perfusion across several surgical disciplines. There has been exponential growth in the field of FIGS since the early 1990s and continues to increase in use annually [3]. Intraoperative adverse events and postoperative complications, such as anastomotic leaks, continue to significantly impact patient safety, increase morbidity and mortality, and raise healthcare costs, stressing the need for advanced tools to enhance surgical precision and outcomes. An analysis published in 2020 of the colorectal and bariatric consequences of anastomotic leaks demonstrated significantly higher costs and longer length of stay for patients, highlighting its burden on the healthcare system [4]. In addition to increased costs and length of stay, high complication rates post-operatively have even been shown to impact overall survival [5-7].

Visual and tactile feedback have long been fundamental tools to intraoperative decision-making, guiding surgeons through the complexities of each procedure. However, even with these essential tools, errors can and do occur. Human senses can be augmented to mitigate these risks and improve patient outcomes. There is an urgent need to develop and utilize advanced tools that provide real-time feedback, enabling surgeons to detect problems early and make more informed, precise decisions during surgery. Advanced visualization with technologies such as fluorescent dyes could enhance precision, reduce human error, identify critical anatomic structures, and ultimately minimize the incidence of complications, such as anastomotic leaks or inadvertent injury, improving patient safety and recovery.

The potential applications for fluorescence image-guided technologies in surgery are vast, yet the data supporting their use remains variable and inconsistent. A prime example is the fluorescent agent ICG. Despite its widespread adoption, it has notable limitations. These include limited penetration in tissue reducing its utility in specific anatomical regions, deep-seated tumors or thick tissue; inconsistent image quality that can vary depending on tissue type, surgical field conditions, and lighting setup; poor photostability and fast degradation when exposed to light, which can reduce its ability to provide clear and consistent signal; a short half-life, which can limit the time window for optimal imaging; and concentration-dependent aggregation, which can compromise the visualization of details [8]. These factors hinder its reliability and effectiveness in specific surgical scenarios and emphasize the importance of evidence-based decision making before implementation into surgical practice. The International Society of Fluorescence Guided Surgery (ISFGS) has established recommended dosages and timing for various applications . Still, these guidelines are based on expert consensus rather than rigorous, evidence-based studies [9]. As a result, the use of ICG remains inconsistent across different surgical settings, highlighting a critical gap in standardization and the need for more robust clinical evidence to guide its optimal application.

To address some of these critical gaps, Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) set out to create a guideline with evidence-based recommendations for implementation into practice and for future research. Areas of interest include its use in thoracic structure identification, malignant lymph node detection, gastrointestinal malignancy margins, and gastrointestinal anastomosis.

METHODS

The creation of these guidelines followed the SAGES Guidelines Development Standard Operating Procedure [10]. The guideline panel used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision (EtD) approach to deliberate and formulate recommendations [11, 12]. The quality of the evidence was performed using GRADEpro GDT as a platform [13]. Reporting of this guideline was structured as per the Essential Reporting Items for Practice Guidelines in Healthcare (RIGHT) checklist [14]. Organizational approval, review and plans for updating were also established.

A systematic review of the evidence informed the guideline recommendations and was performed using the Cochrane Handbook for Systematic Reviews of Interventions and reported according to the “Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)” checklist [15, 16]. The systematic review is published separately and provides detailed methods [17]. Due to the lack of comparative evidence for KQs 1, 7 and 8, Evidence-to-Decision (EtD) tables were not used; rather, the data available was reviewed by the panel and a consensus statement was created.

PubMed, CINAHL, Embase, Cochrane Library, and Clinicaltrials.gov were searched through October 2022 to identify randomized controlled trials and non-randomized comparative studies. A repeat search was performed for KQ5 through September 2024, prompted by experts notifying the guideline working group of several more recent RCTs.

Two independent reviewers screened titles and abstracts of the retrieved records for eligibility using the Covidence platform [18]. Consensus was achieved by third, separate reviewer. Similarly, two independent reviewers performed full text review with a third, separate, reviewer resolving conflicts. Studies were included if they were published in the English language and if there was comparative cohort data, or more than 20 patients for single arm case series in adults or greater than five patients for single arm case series in the pediatric population. Exclusion criteria included pregnant patients, single-arm studies with fewer than 20 patients in the adult population or fewer than 5 in the pediatric population, and case reports.

Extraction of all predetermined outcome data from the selected studies was conducted for each key question by two independent reviewers, followed by consensus and risk of bias assessment. Study quality was assessed using the Cochrane Risk of Bias 2.0 and Newcastle Ottawa Scale for randomized and non-randomized studies, respectively [19, 20]. Random effects meta-analysis was performed on available comparative data.

Guideline Panel Organization

International experts across several surgical subspecialties were invited to participate in the SAGES Guideline Panel. All panel members were experienced surgeons and submitted disclosures on potential conflicts of interest. Additionally, three patient partners that provided their values, preferences and opinions surrounding questions and outcomes. A summary of their input is provided under Values and Patient Perspective. A methodologist with extensive guideline development experience (M.A.) and the SAGES Guidelines Committee Fellow (E.C.C) participated in the panel as non-voting members and facilitated appraisal of the evidence and formulation of the recommendations.

The panel reviewed evidence tables, created with the assistance of the guideline methodologist, populated by the systematic review results and voted on components of the EtD framework to reach final recommendations [21]. Both the evidence tables and EtD tables were compiled using GradePro [13].

Guideline Funding & Declaration and management of competing interests

SAGES provided funding for the methodologist, the systematic review statistician, the librarian, and partial salary support for the guidelines committee fellow. Part of this funding came from a SAGES Education and Research Foundation grant. None of these members were voting members of the guideline panel.

All voting members of the panel participated voluntarily without monetary compensation. Industry did not provide any financial support for or input on these guidelines. All guideline panel members completed SAGES standard conflict of interest forms. The guideline lead and committee chair evaluated these declarations for any pertinent conflicts. All disclosed potential conflicts of interest are listed at the end of the manuscript.

Selection of questions and outcomes of interest

The primary focus for this guideline was to determine whether FIGS with ICG provided advantages compared to standard of care across different surgical applications. Panel members developed key questions in consultation with the guideline methodologist using the PICO format. Several iterations were created with the help of the project leads, the methodologist and fellow until a final version was agreed upon. Outcomes specific to each key question were determined a priori based on what the panel thought key stakeholders, surgeons, and patients would consider relevant. The outcomes based on each key question included:

• KQ1: Intraoperative thoracic duct injury, leak/chylothorax, correct identification of the structure (thoracic duct)
• KQ2-3: R0 resection, correct identification of margin, change in management/operative plan at outset, operating room (OR) time (minutes, continuous variable)
• KQ4: Total number of lymph nodes retrieved, number of positive nodes, lymph node identification, OR time (minutes, continuous variable)
• KQ5-8: Change in transection point prior to anastomosis, re-resection after anastomosis, local repair after anastomosis, postoperative anastomotic leak, anastomotic stricture, reoperation, reintervention

Outcomes were distributed to the panel members and they were asked to rate each outcome on the GRADE scale of 1-9 [22]. Only important and critical outcomes were used in decision-making for these guidelines.

Determining utility values for dichotomous outcomes

Panel members were asked to rate the utility of each outcome for KQs 4-8 on a cardinal scale from 0 to 1, in increments of 0.1, with 0 being death and 1 being the best possible health state [23, 24]. Utility values are preference weights, where preference can be equated to value or desirability [23, 25]. The utility value assigned to it depends on the stakeholder and their personal experience, as well as the clinical question being considered. The mean utility value was calculated for each outcome after panel members voted.

Utility values were then converted to absolute risk difference thresholds according to the equation Absolute Risk Difference = [coefficient/(1-Utility)] x 1000. We used evidence-based, predetermined cutoff coefficients to determine the absolute risk difference decision thresholds for each outcome [29]:

• 0.0135 coefficient for trivial-to-small effect threshold
• 0.0321 coefficient for small-to-moderate effect threshold
• 0.0625 coefficient for moderate to large effect threshold

These cutoffs were used to determine imprecision in the pooled data for each outcome (see Evidence Review and Synthesis section).

To provide a more streamlined and transparent method to determine the balance of effects in panel discussions, utility values were used to calculate coefficients for each outcome. After the certainty of evidence was determined using GRADEpro GDT, the coefficient for each outcome was calculated using the respective absolute threshold difference in the equation Coefficient= Absolute Risk Difference x (1-Utility). We aggregated these values for each outcome, with a positive value given to those that were under “desirable outcomes” and a negative value to those that were “undesirable outcomes” depending on the key question being evaluated. The resulting numerical coefficient for the body of data and the direction and effect size for the Balance of Effects in the EtD tables was determined using this calculated, aggregated coefficient value. The calculated value was compared to the predetermined coefficients described above to determine whether the effect size was trivial, small, moderate or large. These calculations and values were all presented to the panel to ensure that they were appropriate.

Evidence Review and Synthesis

Results from the SAGES systematic review and meta-analysis were uploaded to GradePro GDT to facilitate evidence appraisal and panel decision-making. Evidence that directly compared FIGS with ICG to no FIGS was used in this guideline. Indirect evidence was not deemed necessary and omitted in favor of direct evidence.

Methods outlined in the GRADE handbook were used to judge the certainty of evidence for each outcome of interest [2]. GRADEPro GDT evidence tables were created. Evidence tables for each KQ can be found in Appendix A. The highest level of data available was used for the tables; less rigorous data that addressed the same outcomes was reviewed but not used in decision making. In brief, the guidelines fellow and methodologist judged the certainty of the body of evidence. This data was then imported into the EtD table for each KQ. The EtD format serves as a framework (Appendix B).

The data contributing to decision making for each key question is presented by outcome with the number of studies, total number of participants, certainty of the evidence, statistical method used to evaluate the data with its associated confidence interval (CI), and the absolute risk difference with its associated confidence interval. The odds ratio (OR) was used for dichotomous outcomes, and the mean difference (MD) and standard mean difference (SMD) were used for continuous outcomes. The SMD was used rather than MD if the rating scales used were not identical between studies. The absolute risk difference for binary outcomes is reported as either more or fewer number of patients/cases occurring in the ICG group relative to the comparator (no ICG) group out of 1,000.

The details of ICG administration including route, timing, dosing and imaging system for each study can be found in the systematic review, published separately [17].

Determining Certainty of Evidence

The guidelines fellow and methodologist judged the certainty of evidence for each outcome in each KQ. This data was then used to generate the evidence tables and ultimately inform the evidence review and synthesis presented to the panel using the EtD framework. For each outcome, certainty of evidence was determined by evaluating the risk-of-bias, inconsistency, indirectness, and imprecision of the included studies as per GRADE methodology [27–30]. Too few studies were available to assess publication bias. The level of certainty was downgraded if there were concerns in any of these domains.

Assumed Values and Preferences

As this guideline took a patient-centered rather than a societal perspective, the panel members used their collective patient experience to judge patient values and preferences. In addition, three patient partners provided input on the outcomes and overall decisions. The target audience of this guideline includes surgeons and patients.

Development of recommendations

Outcomes from the evidence table deemed critical and important to decision-making were imported into EtD tables on GRADEPro GDT. Using the EtD tables, the panel discussed desirable effects, undesirable effects, the certainty of evidence, the potential variation in values of key stakeholders, balance of these effects, and acceptability and feasibility of the option favored by the balance of effects [11, 12]. Cost was considered by the panel when creating the recommendations, however no formal cost analysis was performed. After discussing the available evidence for each of these components, as well as pertinent additional considerations noted by the panelists based on interpretation of the evidence or expert experience, the panel voted on each component of the EtD framework. A vote was also administered for the final recommendation of each key question. The recommendation was made when ≥ 80% of cast votes were in accordance. Expert opinion was documented when evidence-based recommendations could not be made because of absent or inconclusive evidence.

Guideline Document review

This guideline was reviewed and edited by all panel members. It was then submitted to the SAGES Board of Governors for approval. It was published online (https://www.sages.org) for two weeks of public comment prior to final submission and publication.

Values and Patient Perspective

Three patient partners (M.H., D.W., B.H.) that have undergone surgery where ICG was used intraoperatively during esophagectomy were recruited and asked for their perspectives and input on outcomes and values of these guidelines. All patients are male and in their 60s, had an esophagectomy in the last year and are currently recovering well. Each independently agreed with the outcomes chosen for these guidelines but did say that complication rate, including anastomotic leak and stenosis were the most important. D.W. included that anything that decreases the amount of ability a person may have would be important. For example, not being able to eat due to a leak would be particularly distressing. B.H. reported that he had the complication of a leak, requiring stent placement for about two months and this was very uncomfortable and distressing for him. They all agreed that if there are extra measures that can be taken in the OR to help decrease complications and ensure that perfusion is adequate and that all lymph nodes have been retrieved, for example, they feel comfortable with it. They all also mirrored that the risks to this seem to be quite low, and that many other medications and studies are administered to them throughout their treatment course and another medication in this entire process would not be a concern. When asked if it had been a procedure that they had to have in advance, e.g. in the case of liver cancer, they all agreed that to them it would be worth it. They emphasized the importance of adequately explaining the procedure and why it is of value and that communication between themselves, their surgeon, and the team was critical to help understand. They also reported that they could not think of a reason why they would not want the ICG administered and that the limited risk and perhaps extra time commitment would be worth it to them as it gives them a feeling of reassurance. They all denied any side effects from the dye that they could recall.

While our patient partners provided valuable feedback it is important to acknowledge that there are limitations to their input considering they are all of a similar demographic and all underwent the same surgery. Therefore, not all patient perspectives may be captured by this.

KEY QUESTIONS

• KQ1: Should the use of ICG versus no ICG be used for intraoperative identification of the thoracic duct?
• KQ2:  Should ICG versus no ICG be used for intraoperative identification of distant (non-regional) cancer metastases?
• KQ3: Should ICG versus no ICG be used for intraoperative identification of primary cancers?
• KQ4: Should ICG versus no ICG be used in patients undergoing resection of gastrointestinal cancers for intraoperative identification of lymph nodes?
• KQ5: Should ICG versus no ICG be used prior to performing a colorectal anastomosis to improve the quality of the anastomosis?
• KQ6: Should ICG versus no ICG be used prior to performing an esophageal anastomosis in patients undergoing resection for esophageal cancer to improve the quality of the anastomosis?
• KQ7: Should ICG versus no ICG be used prior to performing a gastrointestinal anastomosis in patients undergoing bariatric or revisional bariatric operations to improve the quality of the anastomosis?
• KQ8: Should ICG versus no ICG be used in pediatric patients undergoing a pull through to improve the quality of the anastomosis?

RECOMMENDATIONS

KQ1: Should the use of ICG versus no ICG be used for intraoperative identification of the thoracic duct?

Recommendation: FIGS with ICG is a reasonable option to assist in the intraoperative identification of the thoracic duct compared with standard methods (expert opinion).

Background

Injury to the thoracic duct resulting in chylothorax occurs in 2-12% of patients undergoing esophagectomy and in 0.85 to 6.6% of children undergoing cardiothoracic surgery [31, 32]. A thoracic duct leak has substantial effects on patient outcomes including delay in oral intake, increased length of stay in hospital, and association with pneumonia and sepsis. Furthermore, nonoperative management of a thoracic duct leak is associated with high mortality, making intervention a serious consideration, but repeat surgery exposes the patient to further morbidity [31, 32]. For these reasons, the importance of intraoperative identification of the thoracic duct for both prevention and repair of injury (ligation/clipping) is critical to patient safety. Its identification presents a challenge due to its deep location, proximity to critical structures, and anatomic variations and can be especially difficult to identify during reoperation [31]. In this key question, we aim to evaluate the use of FIGS with ICG compared with no ICG for the intraoperative identification of the thoracic duct.

Summary of the evidence

There was very limited evidence in regard to the use of FIGS with ICG for identification of the thoracic duct. Five studies were included in total, one comparative, crossover study [33], and four single-arm studies. Of note, one of the single-arm studies was a case-control study and looked at a comparator involving orally administered whole milk [34]. One of the single-arm cohort studies was targeted at the pediatric population [36]. All other studies were of adult populations. No meaningful conclusions could be made after analysis for the outcomes “identification of structure”, “identification of injury”, nor “chylothorax (leak)” for the adult or pediatric populations.

The only comparative study, Barnes et. al, administered ICG via a feeding jejunostomy and injected ICG into the small bowel mesentery intraoperatively [33]. The three other single arm studies that used ICG administered it subcutaneously either by inter-toe or inguinal subcutaneous injection intraoperatively or within an hour of surgery [31, 32, 35].

Discussion

The data available does not provide enough information to make an evidence-based decision favoring ICG versus no ICG in the identification of the thoracic duct thus an expert consensus was determined.

The panel agreed that the use of FIGS with ICG to identify the thoracic duct during index operation is preferred compared to dissecting out the structures. Dissection of the thoracic duct during the index case can potentially place the structure at risk for injury during this dissection and may not be necessary. Some surgeons also perform mass ligation, but this has become less common. The above expert opinion applies equally to the pediatric population.

Conclusion and Future Research Recommendations

There is a paucity of data regarding the use of FIGS with ICG for thoracic duct identification and injury prevention. The panel agreed that the use of FIGS with ICG in their practice has been helpful for intraoperative identification during an index operation and for identifying and addressing post-operative leaks. It is a reasonable option for surgeons to consider with few downsides. No formal recommendation could be made due to limited evidence, but an expert opinion was formed. Higher quality data with comparative studies is required to further the field.

In addition, the optimal location for dye injection in groin lymph nodes versus root of the mesentery in esophageal cancer surgery to prevent thoracic duct injury should be studied and standardized. Studies have supported both approaches however the panel discussed that the root of the mesentery route is faster and more reproducible [33, 36, 37].

KQ2: Should ICG versus no ICG be used for intraoperative identification of distant, non-regional, cancer metastases?

Recommendation: The panel suggests the use of FIGS with ICG intraoperatively for the detection of distant metastases (conditional recommendation, very low certainty of evidence).
Please note variability in tumor type, neoadjuvant therapy exposure, ICG injection and dose making this recommendation dependent on the patient, pathology and surgeon. ICG is an adjunct tool and does not replace standard surgical assessment methods.

Background

 The importance of diagnosis and resection of metastatic disease on patient survival in certain gastrointestinal cancers is established with speculation that recurrence may be due to undetected micrometastases [38]. The use of FIGS with ICG for detection of metastases has been reported in surgical oncology, but there is limited literature specifically in its utility in detecting aberrant lymph nodes and peritoneal metastases [8, 39]. It has been shown to detect small subcapsular liver metastases and peritoneal implants [40]. In this key question, we aim to evaluate the use of FIGS with ICG compared with no ICG for the detection of non-regional metastases across different gastrointestinal cancers.

Summary of the evidence

There were three studies included in this analysis evaluating liver metastases secondary to colorectal cancer (He et al., Handgraaf et al.) and neuroendocrine tumors (Wang et al.) [41–43]. All studies injected ICG intravenously 1–2 days before surgery. All studies included patients with and with-out neoadjuvant therapy, with no significant difference between ICG and non-ICG groups. The RCT, He et al., was a high-quality, low risk-of-bias study and demonstrated a lower OR time in the ICG group but this was the only outcome of interest reported on [41]. All three studies reported on OR time, however the interpretation and conclusions from this data should be made with caution given the inconsistent direction of effect between RCT and cohort studies.

The two cohort studies, Handgraaf et al. and Wang et al. were low risk-of-bias. They both reported on R0 resection but pooled results had serious inconsistency and imprecision of point estimates. Wang et al. reported on identification of margin with low risk-of-bias. Finally, change in management was supported by Handgraaf et al. with low risk-of-bias but must be critically interpreted considering it is a non-randomized study, and the total number of patients included was low at n=154.

Benefits

ICG was better compared to no ICG with regards to:

• Correct identification of the margin (1 observational study with 145 participants, low certainty of evidence, OR 29.29 CI [1.58–542.3], 112 more per 1,000 CI [39 more to 116 more])
• OR time (1 RCT with 64 participants, low certainty of evidence, MD of 32.16 lower CI [68.67 lower to 4.35 higher])
• R0 resection (2 observational studies with 299 participants, very low certainty of evidence, OR 2.05 CI [0.98–4.31], 132 more per 1000 CI [3 fewer to 175 more]))
• Change in management (1 observational study with 154 participants, low certainty of evidence, OR 2.35 CI [1.02 to 5.43], 127 more per 1,000 CI [2 more to 314 more])

The combined magnitude of these effects was determined to be large.

Harms and burden

ICG did not result in any increased harms based on the data reviewed making the overall effect size trivial.

Certainty of evidence

The overall certainty of evidence was very low.

Decision criteria and additional considerations

The panel recognizes the limitations in the data available to answer this key question, with very low certainty of evidence and critical outcomes only being informed by observational studies. It is important to consider that this data is pooled for different primary cancer subtypes and may influence outcomes due to this heterogeneity. Further, the amount of signal required to identify metastasis has not been established and is another limitation of this data as it could introduce heterogeneity due to potentially different thresholds for a “positive” signal. Lastly, all three studies included in this analysis had patients with and without neoadjuvant therapy which are important subgroups to consider as it could change the characteristics of the primary tumor and therefore change the uptake of ICG.

Overall, the data pointed in favor of FIGS with ICG and thus the panel suggests the use of FIGS with ICG as a tool for surgeons when evaluating for liver metastases intraoperatively. Without clear protocols in place for ICG administration, there may be difficulties including who administers the dye e.g. nurses, surgeons, anesthesiologist, and when to administer it, e.g. requiring another admission prior to surgery, but these difficulties can be mitigated with planning. Alternatives to FIGS with ICG include tactile feedback in open surgery which can have increased morbidity. Other alternatives include detection coils into metastases with image guidance which can be non-specific and can require delays associated with limited personnel needed to perform it. Methylene blue dye is another alternative; however, it can often cause confusion if it escapes the field of interest.

Although the studies in this analysis injected ICG intravenously one to three days prior to operation it is generally accepted that identification of liver metastasis should have ICG injected at least 5-7 days before surgery [9].

Conclusion and Future Research Recommendations

The panel suggests the use of FIGS with ICG for the detection of liver metastases but recognizes that the pool of data supporting this is limited and biased. Further research including larger RCTs and more comparative data is needed. Standardizing the methods for injecting and measuring ICG and its signal with a camera could influence outcomes and should also be a research priority with a potential role for AI. Finally, new isotopes and imaging systems that are more cancer-specific may be superior to FIGS with ICG and studies evaluating their use compared with ICG dye or other techniques should be done.

KQ3: Should ICG versus no ICG be used for intraoperative identification of primary cancers?

Recommendations: The panel recommends the use of FIGS with ICG intraoperatively for intraoperative identification of primary abdominal cancers (strong recommendation, moderate certainty of evidence).
Please note variability in tumor type, neoadjuvant therapy exposure, ICG injection and dose making this recommendation dependent on the patient, pathology and surgeon. ICG is an adjunct tool and does not replace standard surgical assessment methods.

Background

FIGS with ICG has been widely used in cancer-related surgery. One of its applications is the identification of primary cancers including tumor localization and determination of resection margins [8, 39]. Utilization of FIGS with ICG in gastrointestinal cancer began over twenty years ago with advanced laparoscopic surgery where tumor locations and margins could not be determined based on tactile feedback [8, 39]. Controversy persists regarding its efficacy in identification of abdominal primary cancers. In this key question, we aim to evaluate the use of FIGS with ICG compared with no ICG for intraoperative detection of primary cancers.

Summary of the evidence

There were a total of 14 studies included in this analysis [44–57]. Of these, there was one RCT (Liu et al.), with 50 participants and low risk-of-bias, and ten observational studies, with over half of them considered high risk-of-bias. The RCT concerning hepatic cellular carcinoma (HCC) tumors, Liu et al., was used to inform this recommendation as it provided the highest level of evidence for each outcome. Despite this, it is important to note that all outcomes except for OR time had their point estimates in the same direction, favoring FIGS with ICG, in both the randomized and observational studies.

The type of cancer being evaluated across all included studies varied between gastric, hepatic, and biliary as did the method of ICG administration. Four studies evaluated liver tumors, including the single RCT, Liu et al. ICG injection in the RCT was performed 2–3 days prior to surgery intra-venously [44, 51, 53, 57]. ICG injection in the observational studies varied with all performing preoperative intravenous injection and some also including intraoperative positive staining, with ICG directly into the portal branches of the liver, or negative staining, with ICG intravenously injected after clamping of the portal pedicle. Specifically, Jiangxi et al., Lu et al., and Zhang et al. followed protocols involving both preoperative intravenous injection and intraoperative portal branch directed injections. Additionally, timing of preoperative injection varied across observational studies from one to five days prior to surgery. A subgroup analysis was done to separate out the studies with hepatic tumors, Jiangxi et al., Mehdorn et al., and Zhang et al., within the outcomes R0 resection and OR time. There was no appreciable change to the pooled analysis in conducting these sub-group analyses to the heterogeneity or direction of the data and thus the studies were left combined.

Six of the observational studies evaluated ICG use in gastric cancer [45, 47, 49, 52, 54, 56]. All of these studies administered ICG at least one day prior to surgery with endoscopic peritumoral submucosal injection. One study evaluated ICG use in low grade pancreatic head tumors and injected both preoperatively within one day of surgery and intrabiliary during the operation [50]. As previously mentioned it is generally accepted that liver metastases receive IV ICG injection seven days preoperatively.

Benefits

ICG was better compared to no ICG with regards to:

• R0 resection (1 RCT with 50 participants, low certainty of evidence, RR 1.04 CI [0.93 to 1.16], 38 more per 1,000 CI [67 fewer to 157 more])
• Change in management (1 RCT with 50 participants, moderate certainty of evidence, OR 21.00 CI [4.92 to 89.56], 640 more per 1,000 CI [352 more to 757 more])
• Correct identification of margin (1 RCT with 50 participants, low certainty of evidence, OR 9.33 CI [1.05 to 82.78], 240 more per 1,000 CI [10 more to 275 more])

The combined magnitude of these effects was determined to be large.

 Harms and burden

ICG resulted in more:

• OR time (1 RCT with 50 participants, low certainty of evidence, MD 7.32 higher CI [28.87 lower to 43.51 higher])

The combined magnitude of these effects was determined to be trivial.

Certainty of evidence

The overall certainty of evidence was moderate.

Decision criteria and additional considerations

The greatest influence on decision making was the “correct identification of the margin” outcome, as this was considered to be a large effect. The increased rate of R0 resection was also considered significant. Given that this data is limited with regard to the number of studies included, the panel recognizes that although it is suggested to use ICG, it may not be feasible in all settings. Furthermore, the RCT informing the evidence only looked at primary liver cancer, HCC. There were a wide range of malignancies evaluated among the observational studies including hepatic and gastric which could influence outcomes.

Subgroup considerations that could impact the results of this question include subtypes of primary cancer e.g. hepatobiliary, pancreatic, gastrointestinal. Similarly, distinguishing the subgroups within liver malignancy, including primary cancer versus metastases, and those that underwent neoadjuvant therapy, should be considered when interpreting the data.

The method for ICG injection in liver tumors varied across studies in this key question. All included IV injection preoperatively but some also included intraoperative positive or negative staining. To visualize the liver tumor, IV injection should be performed about seven days prior to surgery, as is done for liver metastasis visualization [9]. If attempting to visualize liver segments for resection, then either a positive (inject into the portal branch) or negative (IV) staining technique can be performed intraoperatively. Positive staining technique should be performed prior to hepatic dissection and negative staining technique after portal pedicle closure.

Conclusion and Future Research Recommendations

The panel suggests the use of FIGS with ICG in the identification of primary gastrointestinal cancers (liver and gastric). The panel recognizes that higher quality comparative data is needed to further support the routine use of FIGS with ICG in all abdominal primary cancers. In addition, more studies need to be conducted to validate the data available both for gastric and other abdominal malignancies. The use of FIGS with ICG in the elective versus emergency settings also needs to be evaluated. Furthermore, the timing and dosing of ICG needs to be standardized for each.

KQ4: Should ICG versus no ICG be used in patients undergoing resection of gastrointestinal cancers for intraoperative identification of lymph nodes?

Recommendations: The panel recommends the use of FIGS with ICG intraoperatively in the identification of lymph nodes for patients undergoing resection for gastrointestinal cancers (strong recommendation, high certainty of evidence).
Please note that ICG is an adjunct tool and does not replace standard nodal harvest.

Background

Lymph node localization is often a critical component of gastrointestinal cancer resection but can be challenging. Lymph nodes can be difficult to access in certain anatomical locations, may not present with tactile or visually discriminating features, and are often embedded in fatty tissue which can make them difficult to distinguish. FIGS with ICG has demonstrated increased identification of lymph nodes across several surgical areas [39, 58]. There is also evidence to suggest that dual methods with ICG and radioisotope are especially helpful in lymph node detection in early gastric cancers [39, 59]. In addition, there has also been data to support its use in the detection of lymph nodes in colorectal cancer. Although it has been encouraged for lymph node detection in GI malignancies, the data is variable and has demonstrated high false-negative rates in certain cases. Ultimately, improvement in lymph node detection with subsequent excision helps to more accurately stage patients, guide treatment, and in some cases improve disease-free survival and overall survival [58]. In this key question we explored the role of FIGS with ICG in the intraoperative identification of lymph nodes.

Summary of the evidence

There were a total of 18 studies considered in this analysis [49, 52, 54, 58–72]. The 17 observational studies had a high risk-of-bias in over half of them. One RCT, Chen et al., with 50 participants, had an overall low risk-of-bias and was used to inform this recommendation as it provided the highest certainty of evidence for each outcome [72]. Across all outcomes, RCT and observational data were consistent except in OR time, making this outcome less reliable to interpret.

Gastric cancer was investigated in the RCT and in 13 of the 17 observational studies. All of these studies had peritumoral submucosal injections of ICG either intraoperatively or one day preoperatively via endoscopy. Three observational studies investigated colorectal malignancies, with ICG being injected subcutaneously at four sites peritumoral, intraoperatively, or immediately before surgery [63, 64, 71]. One investigated intrahepatic cholangiocarcinoma, with injection under the liver capsule intraoperatively [70].

Benefits

ICG had similar effectiveness to no ICG with regards to:

• Number of positive nodes (1 RCT with 258 participants, high certainty of evidence, MD 0.1 lower CI [2.57 lower to 2.37 higher])

ICG was better compared to no ICG with regards to:

• Total number of nodes retrieved (1 RCT with 258 participants, high certainty of evidence, MD 8.5 higher CI [5.23 higher to 11.77 higher])

The combined magnitude of these effects was determined to be large.

Harms and burden

ICG resulted in more:

• OR time (1 RCT with 258 participants, moderate certainty of evidence, MD 5.7 higher CI [5.94 lower to 17.34 higher]

The combined magnitude of these effects was determined to be trivial.

Certainty of evidence

The overall certainty of evidence was high. This decision was determined by reevaluating the imprecision of the outcomes by comparing the least benefit (5.23 higher nodes retrieved) to most harm (OR time 17.34 minutes longer). The panel’s decision to favor the use of FIGS with ICG did not change and so imprecision was determined to be unimportant in rating the certainty of evidence, ultimately rendering it high.

Decision criteria and additional considerations

All panelists agreed that the total number of lymph nodes detected played a large role in their overall decision to advocate for FIGS with ICG for this application. This was considered to be a substantial difference and makes the use of ICG a compelling option. It is also worth noting that although the OR time point estimate was technically worse in the ICG group, the point estimate of 5.7 minutes and its range (CI) was considered trivial. OR time and number of positive nodes was largely the same between both groups, and so the benefit of higher node detection seen with ICG compared to no ICG, clearly supports its use, overall.  A dual method for identifying lymph nodes may be optimal (such as ICG dye and technetium-99 tracer), but that was not evaluated in this question.

Subgroup considerations that could impact the results of this question are the same as KQ3, which largely focuses on the differences between specific types of cancer including but not limited to gastric, colorectal and biliary. Another subgroup consideration is dissection of aberrant lymph nodes, or a lymph node outside of its expected anatomic location, with the use of FIGS with ICG. In theory, FIGS with ICG would allow for detection of these nodes, which may otherwise go undetected, and could impact patient outcomes.

Conclusion and Future Research Recommendations

The panel recommends the use of FIGS with ICG for the detection of lymph nodes in gastrointestinal cancers compared with standard operating procedures. More RCTs are needed to further support this data and to stratify its use across different types of cancer including but not limited to gastric, colorectal and biliary. Furthermore, the role of dual-method tracing and comparing ICG with other tracing modalities should be investigated and considered.

KQ5: Should ICG versus no ICG be used prior to performing a colorectal anastomosis to improve the quality of the anastomosis?

Recommendations: The panel recommends the use of FIGS with ICG intraoperatively in patients undergoing left-sided colorectal anastomosis for benign or malignant disease to improve the quality of the anastomosis (strong recommendation, moderate certainty of evidence).
*This recommendation includes patients with a diverting stoma

Background

Despite improvements in surgical techniques and technologies, anastomotic complications remain a common and costly outcome after abdominal surgery. Colorectal anastomotic leaks occur in 1.8 to 19.2% of cases, with the majority occurring in rectal anastomosis [73, 74]. Known risk factors for the complication include male sex, age, low anastomosis, malignant disease, high American Society of Anesthesiologists (ASA) score, malnutrition, immunosuppression, long operative time, emergency operating, preoperative radiotherapy, and perioperative blood loss or transfusion [74–76]. It is associated with significant morbidity for the patient, including increased length of stay, reintervention, and reoperation. One prospective cohort study in 2005 found that those with malignancy had a higher five-year local recurrence rate when their course was complicated by an anastomotic leak versus no leak, however with no change in overall five-year survival [77].

The diagnosis of an anastomotic leak represents another challenge, with varying success in standard imaging modalities and varying time to diagnosis. To further complicate matters, several definitions of anastomotic leak exist, but generally, radiographic demonstration of a large collection of free fluid, extravasation of contrast, or perianastomotic fluid collection is a typical finding used to document an anastomotic leak [76]. Imaging can be negative early on, and symptoms can be vague.

The prevention and diagnosis of an anastomotic leak is of benefit to the patient. Perfusion is one of the intraoperative factors influencing the quality of an anastomosis. One presumed method for reducing leaks is ensuring adequate blood flow to the area of anastomosis and checking for a leak prior to leaving the operative field. FIGS with ICG is a surgical adjunct that serves as a possible modality for demonstrating adequate perfusion and prevention of ischemia-related anastomotic leak. In this key question, we aim to evaluate the use of FIGS with ICG compared with no ICG in improving the quality of colorectal anastomosis and its related outcomes.

Summary of the evidence

There were a total of 40 studies identified in this analysis, however only RCTs and one observational study were used to inform this recommendation as they provided the highest certainty of evidence for each outcome of interest [78–85]. Seven RCTs, totaling 2501 participants, were included with an overall low risk-of-bias. RCT data was used for all outcome data except local repair after anastomosis, as there was no RCT data available and only one observational study with high risk-of-bias. Local repair after anastomosis is defined here as unplanned repair of the anastomosis after its creation during the index operation, such as oversewing. All outcomes measured in these guidelines were measured intraoperatively and up to 90 days postoperatively.

All RCTs and the single observational study included data for left-sided resection only and both benign and malignant disease. Furthermore, in all studies, ICG was infused intravenously, intraoperatively, before the anastomosis was created to determine the point of transection. In most others, another dose of ICG was also given after the anastomosis was created, except Watanabe et al. and Alekseev et al., in which ICG was administered only prior to the anastomosis [78, 84]. One study, Jafari et al., a dose was given afterward and imaged transanal to evaluate the anastomosis [79]. Dosing varied by study, some used weight-based dosing, others a standard mg dose. The International Study Group of Rectal Cancer (ISREC) classifies anastomotic leaks into Grade A, requiring no active treatment, Grade B, which requires treatment but no re-operation, and Grade C, which requires re-operation [86]. All studies included in our analysis included anastomotic leak grades A, B, and C, except Faber et al., which only included Grades B and C. A subgroup analysis of only leaks B and C still favored FIGS with ICG, with an OR 0.54 CI [0.38, 0.77]. For the purposes of this guideline, however, all leak grades were included across all 7 RCTs, as this allowed pooling of the data and Grade A leaks can still cause problems for patients, although perhaps not as acutely as Grades B and C.

Benefits

ICG was better when compared to no ICG with regards to:

• Anastomotic leak (7 RCTs with 2501 participants, moderate certainty of evidence, OR 0.58 CI [0.44 to 0.75], 50 fewer per 1,000 CI [67 fewer to 29 fewer])
• Reoperation (7 RCTs with 2501 participants, high certainty of evidence, OR 0.90 CI [0.62 to 1.30], 5 fewer per 1,000 CI [18 fewer to 14 more])
• Anastomotic stricture (2 RCTs with 341 participants, moderate certainty of evidence, OR 0.33 CI [0.05 to 2.15], 15 fewer per 1,000 CI [22 fewer to 25 more])
• Local repair after anastomosis (1 observational study with 108 participants, very low certainty of evidence, OR 7.89 CI [0.94 to 66.54], 111 more per 1,000 CI [1 fewer to 538 more])
• Change in transection point (4 RCTs with 1532 participants, low certainty of evidence, OR 35.15 CI [8.72 to 141.77], 120 more per 1,000 CI [30 more to 359 more])

The combined magnitude of these effects was determined to be large.

 Harms and burden

ICG was worse at a level determined to be of clinical significance by the panel, in the outcomes of:

• Reintervention (7 RCTs with 2501 participants, moderate certainty of evidence, OR 1.23 CI [0.79 to 1.91], 7 more per 1,000 CI [6 fewer to 26 more])

Although the re-intervention rate was higher in the FIGS with ICG group, it is important to note that this was only the point estimate. The panel agreed that overall the data suggests that the reintervention rates are about the same in both groups, making the effect size trivial.

Certainty of evidence

The overall certainty of evidence was deemed moderate. Although local repair of anastomosis had very low certainty of evidence, all other outcomes had higher importance and had moderate to high certainty of evidence.

Decision criteria and additional considerations

The outcome “local repair of the anastomosis” had the lowest certainty of evidence due to the data coming from a single observational study with high risk-of-bias [85]. This outcome and “change in transection point” are more challenging to compare between the two groups because action on the part of the surgeon in the comparator would require a concern from inspection with the naked eye or tactile feedback, which presumably is done in all cases with or without FIGS. Surgeons may not typically document their required intraoperative changes as the case proceeds, such as redoing an anastomosis. While adjusting the transection point based on ICG findings may seem beneficial, the direct correlation between this modification and reduced anastomotic leak rates is not clearly established. Some studies actually suggest that patients requiring a change in the transection line are actually at a higher inherent risk of anastomotic leaks, possibly because of underlying perfusion issues [87].

Of note, the INTACT trial, a European multi-center trial evaluating the use of FIGS with ICG versus standard operative technique in rectal cancer colorectal anastomosis has not yet been published. Some of the outcomes evaluated were reintervention, leak rate, and change in transection point. It appears that their preliminary data is consistent with our findings and would not change the direction or strength of this guideline. In addition, the ICG-COLORAL RCT, was recently published in March 2025, evaluating ICG imaging in colorectal surgery, but excluded low anterior resections. It appears that their conclusions are consistent with our left-sided anastomosis data and would not change the direction or strength of this guideline [88].

Unfortunately, there was no reported stricture data surrounding the use of ICG in the studies informing this guideline. A stricture would indicate that there was poor perfusion and/or a leak at the anastomotic site which could be missed with a diverting stoma and influence the evidence for the use of FIGS with ICG. In cases where a diverting stoma exists, it is important to evaluate the anastomosis, either endoscopically, with a contrast study, or a combination of both modalities, prior to closing the stoma to ensure that there is no stricture to help inform this outcome.

Subgroup considerations that could impact the results of this question include patients who underwent prior radiation treatment which could impact blood flow and perfusion. The data analyzed in this KQ included left-sided resection and both malignant and benign disease but right-sided resection is a subgroup that should be evaluated, as well as separating out malignant versus benign disease. Left-sided disease and malignant disease may result in more tenuous blood supply, difficult dissection, anastomotic tension and could result in larger differences in outcomes with the use of FIGS with ICG compared to right-sided or benign disease. Further, the inclusion of patients with a diverting stoma was present in five of the seven studies and ranged from 3% to over 70% of the population. This is an important subgroup to consider for the use of FIGS with ICG because, despite an active AL, these patients may not present with upfront sepsis but can have downstream sequelae such as stricture and fistula. Considering most of the studies include patients with diverting stomas, it is likely that FIGS with ICG is supported in this subgroup. Lastly, the practicality of using FIGS with ICG in emergent cases is another subgroup that should be considered relative to elective cases, as its use may not be prudent or result in a difference in outcomes when the patient is already in a state of crisis.

Values

The panel voted that there was probably no important uncertainty or variability. Patients may not be as concerned with events in the operating room as long as there are no outcomes that impact them. However, it may be important for other stakeholders (surgeons) as they are aware of how intraoperative outcomes affect patient outcomes and clinical courses.

Conclusion and Future Research Recommendations

The panel recommends the use of FIGS with ICG intraoperatively for patients undergoing left-sided colorectal anastomosis for benign or malignant disease. Further research is required with the subgroup considerations mentioned above, including those with prior radiation treatment. Right versus left-sided resection may also demonstrate different outcomes, as well as those with malignant versus benign disease, and thus should be studied further. Across all anastomoses, changes in resection margin should be documented regularly with or without the use of FIGS with ICG to collect adequate data to determine if the use of ICG changes practices. Also, providing clear rationale in operative notes for why operative plans are changed will be important. Finally, reporting on the delayed (after 30 days from the index operation) presentation of anastomotic leak, e.g. strictures, dehiscence, sinus and fistula formation, would provide data for diverted patients that may not be clinically present initially and would provide more long-term data overall for the use of FIGS with ICG.

KQ6: Should ICG versus no ICG be used prior to performing esophageal anastomosis in patients undergoing resection for esophageal cancer to improve the quality of the anastomosis?

Recommendations: The panel suggests the use of FIGS with ICG prior to performing esophageal anastomosis among patients undergoing resection of esophageal cancer (conditional recommendation, very low certainty of evidence).
Please note that ICG is an adjunct tool and does not replace standard surgical assessment methods.

Background

The use of FIGS with ICG is recognized as an adjunct for evaluation of esophageal anastomosis, however, the evidence behind its efficacy is uncertain. Perfusion is one of several factors that can contribute to esophageal leak and stricture. Leak is reported to occur in 5-20% of cases and can have devastating effects on the patient including increased morbidity, length of stay and mortality [89, 90]. In this key question, we aim to evaluate when the use of FIGS with ICG intraoperatively improves anastomotic perfusion to ultimately reduce esophageal leak rates.

Summary of the evidence

There were three retrospective cohort studies included in this analysis. No RCT data was available. Two of the three studies had a high risk of bias, and the third had low risk of bias. Overall, the data is very poor considering the uncertainty of the evidence provided and the very serious imprecision seen throughout all four outcomes evaluated below. Two of the three studies reported intravenous injection of ICG, intraoperatively, after the creation of the gastric conduit. The third study did not specify a part from being intraoperative.

Benefits

ICG had similar effectiveness to no ICG with regards to:

• Reintervention (2 observational studies with 406 participants, very low certainty of evidence, OR 0.91 CI [0.46 to 1.79], 9 fewer per 1,000 CI [56 fewer to 70 more])

ICG was better compared to no ICG with regards to:

• Anastomotic leak (3 observational studies with 598 participants, very low certainty of evidence, OR 0.51 CI [0.29 to 0.88], 65 fewer per 1,000 CI [97 fewer to 15 fewer])
• Reoperation (3 observational studies with 598 participants, very low certainty of evidence, OR 0.70 CI [0.36 to 1.35], 22 fewer per 1,000 CI [49 fewer to 25 more])
• Change in transection point (1 observational study with 266 participants, very low certainty of evidence, OR 287.72 CI [17.49 to 4732.20], 28 more per 1,000 CI [98 more to 963 more])

The combined magnitude of these effects was determined to be large.

Harms and burden

The combined magnitude of these effects was determined to be trivial.

Certainty of evidence

The overall certainty of evidence was deemed very low due to all of the studies being observational and two of those three studies having high risk of bias due to lack of comparability.

Decision criteria and additional considerations

Although the data was poor, all outcomes favored FIGS with ICG. The panel agreed that while anastomotic leak (AL) is a complex and multifactorial process [91], evaluating perfusion of the gastric conduit is essential prior to construction of esophageal anastomosis. ICG should be used in conjunction with other strategies to optimize both patient-specific and procedural factors, ultimately reducing the incidence or mitigating complications associated with AL. Altogether, the utilization of ICG represents a promising advancement in enhancing the safety and effectiveness of esophageal surgery.

Conclusion and Future Research Recommendations

The panel suggests the use of FIGS with ICG to evaluate anastomotic integrity in patients undergoing resection for esophageal cancer. There is a need for RCT studies investigating its use in preventing esophageal anastomotic leaks. Further research could be done to evaluate the rate of anastomotic leak in patients who had a change in transection point due to the findings of FIGS with ICG. There is a possibility that this outcome in certain cases is undesirable as it could theoretically lead to more tension or more stricture rates. Ongoing research using ICG quantitative measures of assessing perfusion might help in defining ideal areas within the gastric conduit for construction of the anastomosis

KQ7: Should ICG versus no ICG be used prior to performing a gastrointestinal anastomosis in patients undergoing bariatric or revisional bariatric operations to improve the quality of the anastomosis?

Recommendations:  FIGS with ICG is a reasonable option to assist in primary or revisional bariatric operations but there is currently not enough evidence to determine this for certain (expert opinion).

Background

Bariatric surgery is becoming increasingly common, with over 600,000 cases performed worldwide in 2018. The most common procedures are sleeve gastrectomy and Roux-en-Y gastric bypass (RYGP) [33]. Leak rates for primary laparoscopic gastric bypass in meta-analysis have ranged from 0.1 to 8.3%, with more recent studies demonstrating leak rates of less than 1% in both primary sleeve gastrectomy and RYGP [92, 93]. Rates are as high as 19% in revisional gastric bypass surgery, but again, more recent studies have demonstrated a much lower leak rate, ranging from 0.7 to 2.3% [92, 94]. Anastomotic and gastric leaks can cause significant morbidity, and FIGS with ICG may be a helpful surgical adjunct in reducing their incidence. In this key question, we aim to evaluate the use of FIGS with ICG compared with no ICG in bariatric surgery gastrointestinal anastomosis.

Summary of evidence

There were two comparative, retrospective cohort studies included in this analysis. One study was a crossover study, but methylene blue is a confounder as part of the FIGS with ICG arm [95]. This study reported no anastomotic leak events between the ICG and the no ICG groups. The second study, Kalmar et al., was deemed to have a high risk-of-bias because of poor comparability [96]. This demonstrated no statistically significant difference in anastomotic leak rates between both groups. In both studies ICG was administered intraluminally via naso/orogastric tube after creation of the anastomosis.

Decision criteria and additional considerations

The panel discussed the difference in outcomes surrounding primary versus revisional or conversion bariatric cases. The visual adjunct of FIGS with ICG in revisional cases is of high interest as the anatomy and perfusion could be altered from baseline anatomy. Furthermore, it could be helpful in any case where perfusion appears questionable, when the primary surgery was done elsewhere with limited information, and potential concern for vascular injury not described in operative notes. In addition, the use of FIGS with ICG in special bariatric cases involving concomitant large paraesophageal hernia repair or recurrent hiatal hernia repair is a helpful adjunct to determine adequate perfusion as these cases can require more extensive dissection.

Conclusion and Future Research Recommendations

Current data is inconclusive regarding the utility of FIGS with ICG in bariatric surgery with no significant difference in anastomotic leak rates observed in either of the included studies between groups and the data being deeply flawed. The panel agreed that it is a reasonable option for surgeons to consider with few downsides, especially in revisional or complex cases. No formal recommendation could be made due to limited evidence, but an expert opinion was formed.

Randomized control trials are needed to evaluate the benefit of FIGS with ICG during bariatric surgery anastomosis in either de novo or revision and conversion cases. Future studies should be clear as to which anastomosis is being targeted in bypass cases (most commonly gastrojejunostomy) and whether administration is intraluminal or IV injection.

KQ8: Should ICG versus no ICG be used in pediatric patients undergoing a pull through to improve the quality of the anastomosis?

Recommendations: FIGS with ICG is a reasonable option to assist in the pediatric pull-through cases as compared to standard operative procedure (expert opinion).

Background

Pediatric pull-through procedures involve an anastomosis between healthy bowel and the anus after removal of a diseased segment. Complications secondary to this procedure are high with 30-day readmission rates at 20% and 1-year readmission rates at 36% in one nationwide study [97]. The use of FIGS with ICG in surgery in the pediatric population has been reported in the treatment of varicoceles, chylothorax, lymphatic malformation, and in abdominal and thoracic minimally invasive surgery but there remains a paucity in research for all pediatric surgical applications [98]. In this key question, we aim to evaluate the use of FIGS with ICG compared with no ICG in pediatric pull-through surgery.

Summary of Evidence

There was one single arm study with 13 patients included with no comparative studies available. The anastomotic leak rate was 7.9% (1 out of 13 patients). The reoperation rate was 7.69%, and a change in transection point was performed in 30.77% of cases [99]. No strictures were reported. ICG was administered intraoperatively via the intravenous route.

Discussion

This data cannot be relied upon for its obvious drawbacks of being single arm but also it had a leak rate of 7.9%, which is higher than would be expected for this procedure. The paper did demonstrate resection of more tissue in 4/13 patients, meaning that the intervention resulted in a change from what would have been done and thus perhaps can lead to prevention of leaks.

Access to the required equipment is a barrier in the widespread use of FIGS with ICG in the pediatric population. There are some cases that require a 4mm camera for laparoscopic surgery and thus may not have the capabilities to function with the FIGS system. Furthermore, the panel believed that children’s hospitals have more difficulties getting the equipment needed and for this reason, decreased ability to use ICG in infant pull-throughs. Generally, complication rates of pull-throughs are low, with a leak rate reported of 1-8% depending on the age of the child [100-103]. For this reason, it is very difficult to measure outcome differences using ICG compared to standard operating procedures. The data is limited, and therefore, while there is potential for this technology to be widely used in this population, it is not well understood whether there is a true benefit.

The pediatric surgeons on the panel agreed that the intervention is useful to identify a demarcation line after dissection and allows for more certainty regarding perfusion. Based on data from colorectal anastomoses in the adult population, FIGS with ICG is likely a useful adjunct in the pediatric population for pull-through procedures. It is important to consider, however, that pull-through cases are generally used for the treatment of Hirschsprung’s disease, and so the consideration of where to resect is based on the presence of ganglion cells, not the absence of malignant disease as it often is in adults undergoing colorectal anastomosis. This distinction makes the decision of where to resect more multidimensional in pediatric cases and differs from cancer cases in adults. Overall, it shouldn’t preclude being able to extrapolate the colorectal outcomes from the adult population, but the differences should be appreciated and considered.

Subgroup considerations include stratification of cases based on pediatric age group, severity of disease in each respective pathology requiring pull-through, by the anomaly being repaired and by the type of pull-through procedure. Each of these may require a different level of skill, challenges, and surgical dissection and patient outcomes may differ from the use of FIGS with ICG in each of these cases.

Conclusion and future research recommendations

The data available for the use of FIGS with ICG in pediatric pull-through surgery is severely limited. The panel recognizes the limitations in available evidence and could not come to a formal recommendation but did form an expert opinion after extensive discussion deeming FIGS with ICG a reasonable option for surgeons with few known downsides. High quality comparative studies are needed in order to truly determine if there is a benefit to FIGS with ICG for this procedure.

DISCUSSION

Research recommendations

Many of the research considerations overlapped between key questions. The panel made several recommendations for future research considerations. All key questions, apart from KQ5, would benefit greatly from higher quality studies, namely higher quality prospective/retrospective studies and increased number of randomized controlled trials. All key questions would benefit from standardization in ICG administration across each surgical application for timing and dosing – while ISFGS has started this process, it should be expanded upon. This includes methods of administering and all must be standardized and clearly delineated in research to help compare across studies and ensure technology is being used appropriately. It also includes quantifying imaging technique and visibility. Specifically, each surgical application should understand the amount of signal to objectively determine cutoffs for identifying metastases or perfusion, where and at what distance the camera should be held from the target. In addition, understanding how AI could be useful in processing and determining some of these parameters is of interest.

Considering that FIGS with ICG is not readily available in all hospital systems it is also important to consider comparing ICG with other novel technologies and perhaps the effects of combining these technologies with ICG to make visualization more equitable as it could provide options for different hospitals. It would also provide an alternative for those with iodine allergies. This could include dye-free alternatives, new isotopes and imaging systems, targeted tumor imaging in vivo, ICG coupled with nanoparticles, radioisotope dual method and using different wavelengths and/or isotopes to identify metastases with more specificity and sensitivity.

Patient-driven outcomes including disease-free survival and recurrence rates also need to be studied for the use of FIGS with ICG with lymph node harvesting and primary cancer resection. Longer term outcomes, quality of life, and functional outcomes (e.g. continence, stricture), especially in the pediatric population need to be incorporated into studies as well.

Finally, consideration of surgeon experience with use of FIGS with ICG when collecting outcomes data to demonstrate the learning curve is needed.

Dosing and Timing Chart of Indocyanine Green by Key Question

Implementation of these guidelines

Facilities should ensure that they have the camera equipment required, the contrast/dye and personnel needed to implement the use of FIGS with ICG. There are many different camera systems on the market that provide the correct wavelength to detect the fluorescence of ICG dye. It is important to decide who will be giving the ICG injection – e.g. surgeon, anesthesiologist, nurses. A checklist is a helpful approach to help standardize the process including concentration and dose for each application, parameters for signal strength and camera positioning and finally how, where and when the ICG will be administered. Clear directions should be given to the anesthesia team if they are the ones to administer.

Monitoring and evaluation

Monitoring and evaluation after the implementation of these guidelines is critical to improve upon the current data, and to make the modifications necessary for each unique institution. The application must be taken into consideration but generally speaking outcomes of interest to the surgeon and patient should be compared before and after implementing FIGS with ICG. All outcomes discussed in this guideline for each surgical application should be recorded for patients that undergo FIGS with ICG and those that do not. Depending on the application, leak, stricture, readmission, and need for anastomotic intervention within 30 days should be evaluated. For cases evaluating oncologic outcome of the surgery, disease-free survival and recurrence should be evaluated. Quality of life and functional outcomes following surgery should also be evaluated.

Health Equity

Health equity must be considered as countries, regions and populations may have different experiences with this technology and may have limited access to the materials and equipment required for FIGS with ICG, making the guidelines less generalizable. Hospitals with limited resources and unavailability of the ICG dye or the required camera systems cannot reasonably employ this intervention. In order to make this more accessible, suppliers and professional colleges could help champion closing the gap. Finally, in the cases of primary or metastatic liver cancer, patients in rural areas or those with limited transport may find the additional appointment required to have the dye injected prior to surgery as a barrier to receiving this operative adjunct.

What others are saying

The European Association of Endoscopic Surgery (EAES) published a set of recommendations on the use of FIGS with ICG based on different organ systems in 2023 [106]. There are several overlapping themes and this guideline largely compliments their work. Of note, the use of FIGS with ICG in colorectal anastomosis includes two RCTs, whereas this guideline evaluated seven different RCTs.

In addition, ISFGS is an important resource for current standards on administering ICG on several different organ systems [9]. For example, it has recommendations for timing and dosage of perfusion assessment for colorectal resection, with recommendation for intraoperative injection to evaluate resection margin as well as timing and dosage of ICG in esophagectomy cases with intravenous injection intraoperatively to evaluate perfusion [76, 89]. Although it does not cover all applications and routes, it remains a useful resource for clinicians.

Updating these guidelines

These guidelines will be managed and re-evaluated for update every three years by the Guidelines Update Task Force (GUFT) according to the protocol criteria [107]. The guidelines will be reevaluated at an earlier time if there is evidence of new disruptive data to suggest an earlier update is required.

Limitations of these guidelines

There are several limitations to these guidelines that must be considered. First, there is a paucity of high-quality data in the field of FIGS with ICG. Furthermore, comparisons have been made with older technologies or lack thereof rather than newer technologies. Their direct comparison is also valuable because some facilities may have an easier time obtaining access to newer technologies rather than FIGS with ICG. The limited availability of ICG in certain hospital systems could decrease their practicality. Finally, the lack of standardization in the process makes their implementation more difficult for providers and hospitals and could introduce heterogeneity in outcomes.

ACKNOWLEDGEMENTS

We would like to thank Sarah Colón, the SAGES senior program coordinator, Holly Ann Burt, the SAGES librarian, and the SAGES guideline committee members for their help with the creation of this guideline.

Funding: This study received no external funding. The SAGES Education and Research Foundation (SERF) grant supported the guideline fellow, methodologist, statistician, and librarian. Funding support for the methodologist, research librarians, statistician, and guidelines fellows came from SAGES Education and Research Foundation (SERF) grant. The guidelines fellow (E.C.) is also funded by the Royal Australasian College of Surgeons (RACS) Foundation for Surgery. No industry support was used to create this guideline, nor was any industry input used for any stage of the development, dissemination, or implementation of this guideline. Standard disclosure forms were completed by all guideline contributors to evaluate for potential conflict of interest. Evaluation of these conflicts was made by the panel Chair, and no potential conflicts were deemed to have affected the decision.

Declarations / Disclosures All disclosures were reviewed. Dr. Patricia Sylla had relevant disclosures including consulting fees received from Stryker, Boehringer, Activ Surgical, Olympus, Medtronic, Ethicon, Safeheal. However, she participated as an external advisor and provided extensive feedback to the manuscript but did not participate as a panelist, was not in panel discussions and did not vote. Dr. Deborah S Keller’s institution affiliation has a grant from Arthrex; however, this is not to her and is to the institution only. She receives consulting fees from Medtronic for robot development, unrelated to FIGS/ ICG technology. Dr. Bethany J Slater receives consulting fees from Hologic, unrelated to FIGS/ ICG technology. Dr. Farah Husain teaches multiple advanced bariatric courses and one fellow’s bariatric surgery course over the last 36 months for both Ethicon/J&J and W.L. Gore. The payments were for travel to courses and teaching honoraria. She also moderated an Ethicon breakfast at the annual ASMBS meeting 2024. None of these courses discuss FIGS/ICG technology. They discuss advanced bariatric surgery and revisional surgery for practicing surgeons and/or fellows. Dr. Elisa C Calabrese and Dr. Dena Shehata receive funding from the SERF grant through SAGES. Dr. Sunjay Kumar, Dr. Stefan Scholz, Dr. Ziad Awad, Dr. Jeffrey Chiu, Dr. Subhashini Ayloo, Dr. Nisha Narula, Dr. María Rita Rodríguez-Luna, Dr. Guy Maddern, and Dr. Panagiotis Kapsampelis had nothing to declare.

Ethics approval: Not applicable.
Informed consent: Not applicable.

APPENDICES

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Author Affiliations:

Authors: Elisa C Calabrese^1,2,3, Sunjay Kumar⁴, Dena Shehata⁵, Panagiotis Kapsampelis⁶, Stefan Scholz⁷, Maria Rita Rodriguez-Luna⁸, Nisha Narula⁹, Jeffrey Chiu¹⁰, Farah Husain¹¹, Patricia Sylla¹², Guy Maddern^2,3, Subhashini Ayloo¹³, Ziad Awad¹⁴, Bethany J. Slater¹⁵, Deborah S. Keller¹⁶

1. Department of Surgery, University of California-East Bay, Oakland, CA, USA
2. Department of Surgery, University of Adelaide, The Queen Elizabeth Hospital, Adelaide, SA, Australia
3. Research, Audit and Academic Surgery, Royal Australasian College of Surgeons, Adelaide, SA, Australia
4. Department of Surgery, Thomas Jefferson University Hospital, Philadelphia, PA, USA
5. Department of Surgery, Lahey Hospital and Medical Center, Burlington, MA, USA
6. Leeds Institute of Emergency General Surgery, St James’s University Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK
7. Division of General and Thoracic Pediatric Surgery, Department of Surgery, University of Pittsburgh, Pittsburgh, PA, USA
8. Department of General Surgery, Hospital de Barcelona, Barcelona, Spain
9. Department of Surgery, Rutgers New Jersey Medical School, Newark, NJ, USA
10. Department of General Surgery, Advent Health, Orlando, FL, USA
11. Department of Surgery, University of Arizona College of Medicine Phoenix, Phoenix, AZ, USA
12. Icahn School of Medicine at Mount Sinai Hospital, New York, NY, USA
13. Department of Surgery, Saginaw VA Health Care System, Saginaw, MI, USA
14. Department of Surgery, University of Florida College of Medicine, Jacksonville, FL, USA
15. Mount Sinai Kravis Children’s Hospital, New York, NY, USA
16. Division of Digestive Surgery, University of Strasbourg, Strasbourg, France

Funding statement: This study received no funding.
Ethics approval statement: Not applicable.
Patient consent statement: Not applicable.

Corresponding author:
Elisa Calabrese, SAGES Guideline Fellow