Guidelines for the Use of Intraoperative Imaging of the Common Bile Duct

Authors

Sunjay K. Kumar¹ · Dena G. Shehata² · Lawrence N. Cetrulo³ · Romeo Ignacio⁴ · Jeffrey Chiu⁵ · Brain R. Davis⁶ · Marian McDonald⁷ · Matthew B. Bloom⁸ · Subhashini Ayloo⁹ · Ali Kchaou¹⁰ · Georgios Orthopoulos¹¹ · Philip H. Pucher¹² · Uretz Oliphant¹³ · Peter T. Hallowell¹⁴ · Federico Serrot¹⁵ · David Overby¹⁶ · Eduardo Moreno‑Paquentin¹⁷ · Bethany J. Slater¹⁸ · Emily Miraflor¹⁹

Abstract

Background: There are multiple intraoperative imaging techniques used to increase safety during laparoscopic cholecystectomy, including intraoperative cholangiography (IOC), fluorescent imaging (FI) with indocyanine green (ICG), and laparoscopic ultrasound (LUS). This guideline addresses the optimal intraoperative imaging technique during laparoscopic cholecystectomy for benign biliary disease.

Methods: A systematic review was conducted to address five key questions regarding the use of intraoperative imaging of the common bile duct. These results were then presented to a panel of practicing surgeons who formulated recommendations based on the best available evidence.

Results: Conditional recommendations were made in favor of performing IOC in adult and pediatric patients and doing so routinely rather than selectively, IOC rather than FI with ICG, and either IOC or LUS.

Conclusions: These recommendations should provide guidance regarding the use of intraoperative imaging techniques during laparoscopic cholecystectomy. This guideline also identifies important areas where the future research should focus to strengthen the evidence base.

Keywords: Common bile duct injury · Intraoperative cholangiography · Fluorescence imaging · Laparoscopic ultrasound · Guideline

ABBREVIATIONS & ACRONYMS
CBD: Common bile duct
CI: Confidence interval
CVS: Critical view of safety
GRADE: Grading of Recommendations Assessment, Development and Evaluation
EtD: Evidence-to-Decision table
FI:  Fluorescence imaging
ICG: Indocyanine green
IOC: Intraoperative cholangiography
LUS: Laparoscopic ultrasound
OR: Odds ratio
RCT: Randomized controlled trial
RR: Relative risk
SAGES: The Society of American Gastrointestinal and Endoscopic Surgeons

Executive Summary

Background

Laparoscopic cholecystectomy is one of the most common operations performed by general surgeons. A number of intraoperative imaging techniques have been developed to be used alongside the critical view of safety, including contrast cholangiography, fluorescence imaging using indocyanine green, and laparoscopic ultrasound. This guideline provides guidance on the use of intraoperative imaging techniques during laparoscopic cholecystectomy for benign biliary disease.

Methods

Systematic literature reviews were conducted for five key questions regarding intraoperative imaging techniques during laparoscopic cholecystectomy. The Cochrane Library, Clinicaltrials.gov, Embase, PubMed, and the International Clinical Trials Registry Platform were searched to identify randomized controlled trials and non-randomized comparative studies. Evidence-based recommendations were formulated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology by subject matter experts. GRADE is a transparent framework used in the development of clinical practice guidelines, using the highest-level evidence available. Recommendations for future research were also proposed.

Interpretation of strong and conditional recommendations

All guideline recommendations were assigned either a “strong” or “conditional” recommendation. The words “the guideline panel recommends” are used for strong recommendations, and “the guideline panel suggests” for conditional recommendations, as per the GRADE approach. A conditional recommendation signals that the benefits of adhering to a recommendation probably outweigh the harms although it does also indicate 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

The primary aim of these guidelines is to provide guidance for surgeons choosing an intraoperative imaging technique to utilize during laparoscopic cholecystectomy. They are also intended to provide education for patients, inform advocacy, and describe future areas for research. Given the lack of strong evidence, these recommendations provide guidance but not mandates. The wide variety of clinical scenarios will require adjustment of treatment plans to suit the needs and priorities of the individual patient and treatment setting. Finally, because the guidelines take a patient-centered approach, patients can use these guidelines as a source of information and basis for discussion with their physicians.

Recommendations

 KQ1: In patients undergoing laparoscopic cholecystectomy for benign biliary disease, is performing IOC superior to not performing IOC?

• The panel suggests performing IOC in adult patients undergoing laparoscopic cholecystectomy for benign biliary disease (conditional recommendation, low certainty of evidence)
• The panel suggests performing IOC routinely rather than selectively in patients undergoing laparoscopic cholecystectomy for benign biliary disease (conditional recommendation, low certainty of evidence)
• The panel suggests performing IOC in pediatric patients undergoing laparoscopic cholecystectomy for benign biliary disease (conditional recommendation, very low certainty of evidence)

KQ2: In patients undergoing laparoscopic cholecystectomy for benign biliary disease, is IOC superior to FI with ICG?

• The panel suggests performing IOC over utilizing FI with ICG in patients undergoing laparoscopic cholecystectomy for benign biliary disease (conditional recommendation, low certainty of evidence)

KQ3: In patients undergoing laparoscopic cholecystectomy for benign biliary disease, is IOC superior to LUS?

• The panel suggests either performing IOC or utilizing LUS in patients undergoing laparoscopic cholecystectomy for benign biliary disease (conditional recommendation, low certainty of evidence)

ABBREVIATIONS & ACRONYMS
CBD: Common bile duct
CI: Confidence interval
CVS: Critical view of safety
GRADE: Grading of Recommendations Assessment, Development and Evaluation
FI:  Fluorescence imaging
ICG: Indocyanine green
IOC: Intraoperative cholangiography
LUS: Laparoscopic ultrasound
OR: Odds ratio
RCT: Randomized controlled trial
RR: Relative risk
SAGES: The Society of American Gastrointestinal and Endoscopic Surgeons

Introduction

Aim of these guidelines and specific objectives

The purpose of these guidelines is to provide evidence-based recommendations for the use of intraoperative imaging modalities during laparoscopic cholecystectomy. We assessed surgical outcomes that were deemed to be important to both surgeons and patients by a panel of surgeons. Specifically, the imaging modalities investigated were contrast intraoperative cholangiography (IOC), fluorescence imaging (FI) with indocyanine green (ICG), and laparoscopic ultrasound (LUS). The target audience for these guidelines includes surgeons and patients. A patient-physician perspective was taken so cost-effectiveness, resources requirements, and availability of said resources were not evaluated. These imaging modalities were primarily assessed in the context of the American healthcare system. Therefore, the recommendations here may not apply in settings where the relevant technology is not easily accessible.

Description of the health problem

Laparoscopic cholecystectomy is one of the most common abdominal operations performed in the United States [1]. Injury to the common bile duct is a rare but dreaded complication, often requiring additional surgery or endoscopic intervention. Its occurrence has been increasing since the introduction and widespread adoption of laparoscopy (0.4–1.5% of cases) compared to open cholecystectomy [2, 3]. Multiple factors may contribute to the risk of common bile duct injury, including the presence of acute inflammation and anatomical variability of the CBD. Strategies such as achieving the Critical View of Safety (CVS) were developed to mitigate this risk [4].

Intraoperative imaging techniques are adjuncts to the CVS. Contrast cholangiography was performed in the era of open cholecystectomy by injecting contrast directly into the gallbladder or cystic duct to opacify the biliary tree under X-ray examination [5]. Fluorescence technology utilizing ICG and LUS are newer tools. ICG is injected intravenously, taken up by hepatocytes, excreted in bile, and viewed under near-infrared light to observe fluorescence [6]. LUS entails introducing and applying a small ultrasound probe to structures in the operative field to clarify the vascular and biliary anatomy and identify CBD stones [7].

In addition to clarifying anatomy and avoiding CBD

injury, these imaging tools have the potential to identify CBD stones at the time of laparoscopic cholecystectomy. This allows for concomitant cholecystectomy and treatment of CBD stones, rather than requiring an additional procedure or readmission in the late postoperative period for choledocholithiasis, gallstone pancreatitis, or delayed-onset cholangitis.

How to use these guidelines

The aim of these guidelines is primarily to assist surgeons who are deciding which intraoperative imaging technique, if any, should be used during laparoscopic cholecystectomy. These guidelines are also intended to provide education, inform advocacy, and describe potential future areas for research. While these are meant to highlight the optimal approach in a generalized patient population, distinct patient needs, comorbidities, resource limitations, and other unique situations may require adjustments to determine the ideal treatment for each patient. In addition, these guidelines can serve as a resource for patients to promote discussion with their physicians.

Methods

This guideline was developed according to the SAGES Guidelines Taskforce Standard Operating Procedure [8]. In brief, a systematic review of the literature was completed to inform the guideline recommendations. The panel developed and graded the recommendations employing the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, the GRADE guideline development tool, and the Essential Reporting Items for Practice Guidelines in Healthcare checklist [9-12].

Guideline Panel Organization

An expert panel was selected from within the SAGES Guidelines Committee to create a systematic review for this intraoperative CBD imaging guideline. Members of the Safe Cholecystectomy Task Force participated in the project design and as members of the expert panel. The systematic review was overseen by a methodologist with systematic review expertise (A.A.). The panel was composed of practicing surgeons from the Society of American Gastrointestinal and Endoscopic Surgeons. The Guidelines Committee fellow (S.S.K.) facilitated guideline panel meetings as a non-voting member of the panel. The panel used the GRADE methodology to assess the evidence from the systematic review and judge certainty of evidence and the strength of guideline recommendation [9. 10].

Guideline funding and declaration and management of competing interests

SAGES provided funding for the librarian who assisted with the systematic review, the systematic review statistician, and the Guidelines Committee Fellow. Part of this funding came from a SAGES Education & Research Foundation grant. Industry did not provide any financial support nor any input into the conception or development of this guideline. A standard SAGES conflict of interest form was collected from all guideline contributors by the guideline lead. A full list of declarations is listed at the conclusion of this manuscript.

Selection of questions and outcomes of interest

Guideline panelists formulated key questions (KQs) relevant to intraoperative imaging of the CBD during laparoscopic cholecystectomy according to the Population, Intervention, Comparison, Outcome (PICO) format, in consultation with members of the Safe Cholecystectomy Taskforce,  methodologist, guideline lead, and committee Chair (B.S.). KQs were approved by a SAGES Guidelines committee working group.

The panel members used their extensive clinical experience to identify patient-centered outcomes they believed most surgeon-patient dyads would consider important to decision-making. These outcomes were chosen based on panel consensus by simple majority and then further designated as critical or important to decision-making on the basis of their relative perceived importance to patients. This designation was confirmed by panel members during the formulation of recommendations after reviewing the evidence from the systematic review.

Evidence review and synthesis

A systematic review addressing the KQs was conducted according to the SAGES Guidelines Committee’s standard operating procedure [8]. The Cochrane Library, Clinicaltrials.gov, Embase, PubMed, and the International Clinical Trials Registry Platform databases were searched from their inception to October 2022 for evidence. Search strategies can be found in Appendix A.

Each record was screened by two independent reviewers at both the abstract and full text review phases. Screening criteria and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flowsheets can be found in Appendix B. Study quality was assessed using the Newcastle Ottawa scale and Cochrane Risk of Bias Tool 2.0 for observational and randomized studies, respectively [13, 14]. Random effects meta-analysis was performed on the extracted data.

Determining the certainty of evidence

As per the Guidelines Committee’s standard operating procedure, the GRADE approach was utilized to judge the certainty of evidence available for each outcome. The highest level of evidence identified was imported into GRADEPro evidence tables [11]. The certainty of this evidence was evaluated on the basis of its risk of bias, inconsistency, indirectness, and imprecision. The certainty was downgraded based on the number of domains across which there were concerns. This data was then imported into an Evidence to Decision table for each KQ which provided the framework through which the expert panel developed its recommendations. Evidence tables and Evidence to Decision tables can be found in Appendices C and D, respectively.

Assumed values and preferences

The panel members used clinical experience to inform judgment on the valuation of different outcomes on behalf of patients. This expertise was deemed likely sufficient to anticipate the variation in values by patients informed by the same evidence. Empiric evidence of how patients value these outcomes was not searched; however, one patient partner was interviewed to provide input on the recommendation
and contribute their perspective on values and preferences.
The panel also served as a proxy for broader patient values
in the absence of additional direct evidence.

Development of recommendations

The panel convened virtually in the winter of 2023 to review the evidence and make recommendations. The results of the systematic review and the articles utilized were available for independent review prior to the meetings. During the meetings, the panel members reviewed the evidence and completed the Evidence to Decision tables to generate recommendations. This process entailed deliberating the magnitude of desirable and undesirable effects, the certainty of evidence, and variation in how patients may value outcomes. After this, the panel voted on whether the overall balance of these considerations favored the intervention or comparison. The panel then discussed the acceptability and feasibility of this judgment. For each decision, both the available evidence was discussed as well as pertinent additional considerations taken either from panel expert experience or interpretation of evidence. Based on the balance of effects and the acceptability and feasibility of a favored option, the panel voted on the final recommendation for that KQ. While serial voting was used to come to a consensus on individual components of the EtD, 80% agreement was mandatory for all final recommendations.

Subgroups were discussed in the justification for each recommendation and are specified for each KQ where relevant. Full evidence to decision tables are presented in Appendix D and summarized in the following recommendations.

Guideline Document review

This guideline was drafted based on the evidence to decision tables and panel discussion and was edited by all panel members. In accordance with SAGES Guidelines Committee policies, the final draft was distributed to all of the coauthors for approval or suggested changes. After incorporating these edits, the Guideline was then submitted to SAGES board for approval and published online for public comment for two weeks.

Recommendation for future research

The authors have provided a concise review of potential avenues for future research for each KQ discussed. These were made based on gaps in the literature identified during the review process.

KEY QUESTIONS

• KQ1: In patients undergoing laparoscopic cholecystectomy for benign biliary disease, is performing IOC superior to standard surgical technique?
• KQ1b: In patients undergoing laparoscopic cholecystectomy for benign biliary disease, should IOC be used routinely or selectively?
• KQ1p: In pediatric patients undergoing laparoscopic cholecystectomy for benign biliary disease, is IOC superior to standard surgical technique?
• KQ2: In patients undergoing laparoscopic cholecystectomy for benign biliary disease, is IOC superior to FI with ICG?
• KQ3: In patients undergoing laparoscopic cholecystectomy for benign biliary disease, is IOC superior to LUS?

RECOMMENDATIONS

KQ1: In patients undergoing laparoscopic cholecystectomy for benign biliary disease, is performing IOC superior to not performing IOC?

The panel suggests performing IOC in adult patients undergoing laparoscopic cholecystectomy for benign biliary disease (conditional recommendation, low certainty of evidence).

Summary of the evidence

The panel’s recommendation was informed by evidence from two randomized controlled trials (RCTs) and ten observational studies [15]. Both RCTs used a strategy of routine IOC. Four of the observational studies used a strategy of routine IOC, while six of them used a strategy of selective IOC.

Benefits

The benefits of utilizing IOC included identification of aberrant anatomy (e.g., aberrant right sectoral ducts, subvesical
duct, anomalous drainage of intrahepatic ducts), intraoperative
identification of CBD stones, less need for postoperative imaging, fewer postoperative biliary leaks, and fewer postoperative CBD stones. The aggregate of these effect estimates was judged to be moderate. Effect estimates for critical outcomes are presented below.

• Identification of aberrant anatomy: estimated 97 more per 1,000 patients (95% CI 4 more to 304 more) based on four observational studies with 7,138 patients
• Intraoperative identification of CBD stones: OR 73.81 (95% CI 4.36 to 1249.12) based on one RCT with 122 patients
• Postoperative identification of CBD stones: 4 fewer per 1,000 patients (95% CI 5 fewer to 37 more) based on one RCT with 371 patients

Harms and burden

Harms of utilizing IOC included longer OR time, more unsuccessful intraoperative imaging attempts and need to utilize a second technique, more intraoperative bleeding, and more postoperative endoscopic interventions. The aggregate of these effect estimates was judged to be small. Effect estimates for critical outcomes are presented below.

• Unsuccessful intraoperative imaging attempt: OR 8.28 (95% CI 1.02 to 67.47) based on two RCTs with 493 patients

Certainty of evidence

The overall certainty of evidence for this question was rated as low due to concerns over the comparability of the two groups in the observational studies, effect estimates with wide CIs frequently crossing from harm to benefit, and rare outcomes whose effect estimates are susceptible to random statistical variation.

Decision criteria and additional considerations

Overall, the panel felt that the benefits and harms were fairly balanced with the exception that IOC permits the surgeon to identify aberrant anatomy. This gives it meaningful potential to decrease the rate of missed BDI. It acknowledges that in certain settings, the increased operating room (OR) time, the availability of the C-arm, need for x-ray technicians to operate the C-arm, and potentially the fluoroscopy licensing exam may present barriers to the implementation of routine performance of IOC. It is important to note that false positive results, such as those caused by air bubbles, can occur with studies reporting rates as high as 36% [16, 17]. This can potentially lead to additional unnecessary procedures such as CBD exploration or ERCP. The standard of care for intraoperative cholangiography is with the use of fluoroscopy, as it provides superior accuracy in assessing the biliary tree compared to flat plate techniques due to the ability to obtain multiplanar images timed with simultaneous contrast injection.

In patients at high risk for CBD stones, patients with preoperative imaging suggesting aberrant anatomy, or the setting of intraoperative uncertainty over the anatomy, the conditional recommendation for the use of IOC would be strengthened.

The panel also noted the importance of continuing to train general surgery residents in the performance and interpretation of IOC including the determinations of IOC quality prior to analysis. For example, a high-quality normal IOC should show both right and left bile ducts and contrast flowing into the duodenum without filling defects. Similarly, practicing general surgeons who perform cholecystectomies
should also maintain proficiency in the performance and interpretation of intraoperative cholangiography.

Research recommendations

Future research should focus on high-quality comparative studies of routine versus selective IOC to better assess its impact on bile duct injury, stone detection, and postoperative outcomes. Additionally, studies are needed to evaluate how training and surgeon proficiency in IOC performance and interpretation influence accuracy and patient safety.

KQ1b: In patients undergoing laparoscopic cholecystectomy for benign biliary disease, should IOC be used routinely or selectively?

The panel suggests performing IOC routinely in patients undergoing laparoscopic cholecystectomy for benign biliary disease (conditional recommendation, low certainty of evidence).
The panel noted that in patients with normal laboratory values, a definitive CVS, and no other indication for an IOC, this conditional recommendation for routinely performing IOC should be considered on an individual basis, taking into account surgeon experience, patient-specific factors, and institutional resources.

Summary of the evidence

The panel’s recommendation was informed by evidence from two randomized controlled trials (RCTs) and three observational studies [15].

Benefits

The benefits of utilizing IOC routinely included identification of aberrant anatomy, intraoperative identification of CBD stones, intraoperative identification of BDI, fewer postoperative endoscopic interventions, reduced need for postoperative imaging, and a lower incidence of retained CBD stones. The aggregate of these effect estimates was judged to be moderate. Effect estimates for critical outcomes are presented below.

• Identification of aberrant anatomy: estimated 1 more per 1,000 patients (95% CI 9 fewer to 163 more) based on one RCT with 190 patients
• Intraoperative identification of BDI: estimated 3 fewer per 1,000 patients (95% CI 7 fewer to 34 more) based on two RCTs with 493 patients
• Intraoperative identification of CBD stones: estimated 36 more per 1,000 patients (95% CI 2 more to 126 more) based on two RCTs with 493 patients
• Postoperative identification of CBD stones: estimated 7 fewer per 1,000 patients (95% CI 17 fewer to 31 more) based on two RCTs with 493 patients

Harms and burdens

Harms of utilizing IOC routinely included more intraoperative bleeding events (the causality of the bleeding events could not be determined and may reflect a higher case complexity in those cases where IOC was performed) and more unsuccessful intraoperative imaging attempts. The aggregate of these effect estimates was judged to be small. Effect estimates for critical outcomes are presented below.

• Unsuccessful intraoperative imaging attempt: estimated 176 more per 1,000 patients (95% CI 77 more to 355 more) based on two RCTs with 493 patients

Certainty of evidence

The overall certainty of evidence for this question was rated as low due to effect estimates with wide CIs frequently crossing from harm to benefit and rare outcomes whose effect estimates are susceptible to random statistical variation.

Decision criteria and additional considerations

The suggestion of a lower rate of BDI and the ability to detect them intraoperatively rather than postoperatively largely contributed to this recommendation. Additionally, the panel noted that from a practical standpoint, routinely performing the IOC will improve the performance and efficiency of the surgeon and the rest of the operating room staff, but should be guided by clinical necessity.

The panel noted that in patients with normal laboratory values, a definitive CVS, and no other indication for an IOC, this conditional recommendation for routinely performing IOC could be considered on an individual basis. Likewise, in pregnant patients the panel would not recommend routinely performing IOC. In these patients, selective use can be employed based on clinical suspicion and indication for intraoperative imaging technique (e.g., gallstone pancreatitis) in order to minimize radiation exposure.

If implementing a policy of routine IOC, it is essential to monitor the false positive rate of identification of CBD stones. False positive interpretations of an IOC can lead to unnecessary endoscopic procedures for patients and prolonged length of stay.

Routine use of intraoperative cholangiography can provide an essential tool for preventing bile duct injury; however, patient radiation exposure and the cumulative effects of repeated exposure for providers should also be acknowledged and considered in its implementation.

Research recommendations

Future research should prioritize multicenter studies to address this question, ideally through RCTs. If RCTs are not feasible, prospective cohort studies with long-term follow-up should be conducted to provide high-quality evidence and capture comprehensive outcomes over time.

KQ1p: In pediatric patients undergoing laparoscopic cholecystectomy for benign biliary disease, is IOC superior to standard surgical technique?

The panel suggests performing IOC in pediatric patients undergoing laparoscopic cholecystectomy for benign biliary disease (conditional recommendation, very low certainty of evidence).

This key question examines whether intraoperative cholangiography offers added benefit over standard surgical care in pediatric patients undergoing laparoscopic cholecystectomy for benign biliary disease. Standard care typically involves achieving the critical view of safety or involves laparoscopic cholecystectomy without routine preoperative or intraoperative imaging, unless clinically indicated.

Summary of the evidence

The panel’s recommendation was informed by evidence from five observational studies [15]. One of the observational studies used a strategy of routine IOC while four of them used a strategy of selective IOC.

Benefits

The benefits of utilizing IOC in the pediatric population included fewer intra- and postoperatively identified BDIs, more intraoperatively identified CBD stones, and fewer postoperatively identified CBD stones. The aggregate of these effect estimates was judged to be moderate. Effect estimates for critical outcomes are presented below.

• Intraoperative identification of BDI: estimated 22 fewer per 1,000 patients (95% CI 23 fewer to 18 fewer) based on one observational study with 2,865 patients
• Postoperative identification of BDI: estimated 18 fewer per 1,000 patients (95% CI 21 fewer to 16 more) based on three observational studies with 208 patients
• Intraoperative identification of CBD stones: OR 6.71 (95% CI 0.78 to 58.05) based on two observational studies with 110 patients
• Postoperative identification of CBD stones: estimated 6 fewer per 1,000 patients (95% CI 9 fewer to 2 more) based on one observational study with 2,865 patients

Harms and burdens

Harms of utilizing IOC in the pediatric population included longer OR time, more unsuccessful intraoperative imaging attempts, radiation exposure, and more postoperative endoscopic interventions. The aggregate of these effect estimates was judged to be small. Effect estimates for critical outcomes are presented below.

• Unsuccessful intraoperative imaging attempt: OR 1.72 (95% CI 0.07 to 44.58) based on one observational study with 48 patients

Certainty of evidence

The overall certainty of evidence for this question was rated as very low due to concerns over the comparability of the two groups, effect estimates with wide CIs frequently crossing from harm to benefit, and rare outcomes whose effect estimates are susceptible to random statistical variation. The study which informed the intraoperative BDI outcome was a study of pediatric patients who required readmission after laparoscopic cholecystectomy, which partially but not entirely explains the large protective effect against BDI which the authors identified.

Decision criteria and additional considerations

The deleterious effects of radiation exposure are potentially more meaningful in the pediatric population than they are in the adult population, given the patients’ longer lifespan. As noted in the prior question, the panel would recommend against the routine performance of IOC in this group. The same considerations apply to pregnant pediatric patients.

The availability of advanced gastroenterologists who can perform endoscopic biliary interventions is typically much more limited in a pediatric hospital than a large adult hospital. Thus, it may be more important for the surgeon to identify and treat identified common duct stones intraoperatively. However, this can also be a challenge as the cystic duct may be smaller than in adults, leading to difficulties in access
with standard catheters.

Regardless, IOC remains an important part of training in both general surgery residency and pediatric surgery fellowship.

Research recommendations

Future research should focus on generating reproducible data on the rate of bile duct injury (BDI) in pediatric laparoscopic cholecystectomy and updating the prevalence of choledocholithiasis in this population. Prospective studies are needed to establish pediatric-specific criteria for the diagnosis and treatment of choledocholithiasis, ensuring tailored and effective care. Additionally, investigating the relative risk of radiation exposure from IOC in pediatric patients is essential to balance diagnostic accuracy with safety.

KQ2: In patients undergoing laparoscopic cholecystectomy for benign biliary disease, is IOC superior to FI with ICG?

The panel suggests performing IOC over utilizing FI with ICG in patients undergoing laparoscopic cholecystectomy for benign biliary disease (conditional recommendation, low certainty of evidence).

Summary of the evidence

The panel’s recommendation was informed by evidence from one RCT and three observational studies [15].

The overall certainty of evidence for this question was rated as low due to missing data for critical outcomes, some inconsistent effect estimates across studies, wide CIs frequently crossing from harm to benefit, and rare outcomes whose effect estimates are susceptible to random statistical variation.

Benefits

The benefits of utilizing IOC rather than FI with ICG included fewer intraoperatively identified BDIs, more intraoperatively identified stones, and less need for a second imaging technique. The aggregate of these effect estimates was judged to be large. Effect estimates for critical outcomes are presented below.

• Intraoperative identification of BDI: estimated 11 fewer per 1,000 patients (95% CI 17 fewer to 117 more) based on one RCT with 120 patients
• Intraoperative identification of CBD stones: RR 5.0 (95% CI 0.25 to 102.00) based on one RCT with 120 patients

Harms and burdens

Harms of utilizing IOC rather than FI with ICG included longer operation time, more postoperative endoscopic interventions, and more unsuccessful imaging attempts. The aggregate of these effect estimates was judged to be large. Effect estimates for critical outcomes are presented below.

• Unsuccessful intraoperative imaging attempt: RR 19 (95% CI 1.13 to 319.27) based on one RCT with 120 patients

Decision criteria and additional considerations

The panel acknowledges that the outcome of BDI is challenging to study given its low event rate; the panel also noted that using FI with ICG is still better than using no intraoperative imaging technique, though this was not the focus of this KQ.

A number of other considerations may make IOC superior to FI with ICG. A C-arm or plain film cholangiogram may be a more accessible technology than the equipment required to view fluorescence. In addition, the decision to use ICG must be made early, as it is typically administered shortly after the induction of general anesthesia or in the preoperative area. In cases of acute cholecystitis, the fluorescence may be difficult to visualize making the technique less helpful in these cases. Additionally, patients with iodine allergies may not be able to receive ICG. Lastly, unlike IOC, FI with ICG lacks the ability to perform direct interventions, such as duct flushing, to enhance visualization or manage obstructions during the procedure.

Research recommendations

Future studies should include comparative trials of IOC versus FI with ICG to determine which intraoperative findings with ICG are sufficient to eliminate the need for additional imaging techniques. Additionally, larger studies with greater statistical power are needed to identify any potential differences in BDI detection rates between these two approaches.

KQ3: In patients undergoing laparoscopic cholecystectomy for benign biliary disease, is IOC superior to LUS?

The panel suggests either performing IOC or utilizing laparoscopic ultrasound in patients undergoing laparoscopic cholecystectomy for benign biliary disease (conditional recommendation, low certainty of evidence).

Summary of the evidence

The panel’s recommendation was informed by evidence from nine observational studies [15].

The overall certainty of evidence for this question was rated as low due to some outcomes only being informed by high risk of bias studies, inconsistent results across studies for some outcomes, concerns over the comparability of the two groups in the observational studies, effect estimates with wide CIs frequently crossing from harm to benefit, and rare outcomes whose effect estimates are susceptible to random statistical variation.

Benefits

The benefits of utilizing IOC rather than LUS included less need for a second intraoperative imaging technique and more identification of aberrant anatomy. The aggregate of these effect estimates was judged to be moderate. Effect estimates for critical outcomes are presented below.

• Identification of aberrant anatomy: OR 10.35 (95% CI 0.54 to 197.45) based on one observational study with 103 patients

Harms and burdens

Harms of utilizing IOC rather than LUS included longer operation time, more postoperative endoscopic interventions, more intraoperatively identified BDIs, more postoperatively identified BDIs, fewer intraoperatively identified CBD stones, more postoperatively identified CBD stones, and more unsuccessful attempts at using the imaging modality. The aggregate of these effect estimates was judged to be moderate. Effect estimates for critical outcomes are presented below.

• Intraoperative identification of BDI: estimated 8 more per 1,000 patients (95% CI 2 fewer to 163 more) based on 3 observational studies of 1,460 patients and assuming a BDI rate of 0.3% in LUS
• Postoperative identification of BDI: OR 1.18 (95% CI 0.05 to 29.08) based on one observational study of 954 patients
• Intraoperative identification of CBD stones: estimated 9 fewer per 1,000 patients (95% CI 25 fewer to 10 more) based on seven observational studies of 4,251 patients
• Postoperative identification of CBD stones: estimated 5 more per 1,000 patients (95% CI 1 fewer to 16 more) based on seven observational studies of 4,251 patients
• Unsuccessful intraoperative imaging attempt: estimated 44 more per 1,000 patients (95% CI 8 more to 166 more) based on seven observational studies of 4,597 patients

Decision criteria and additional considerations

The panel noted that the low event rate and low quality data for BDI made it difficult to consider this outcome in voting. Other important outcomes such as intraoperative identification of stones, need for a second imaging technique, and postoperative endoscopic intervention, were fairly balanced.

Additional benefits of LUS include that it can be used in pregnant patients, it does not require additional personnel to perform, and it does not require creating a ductotomy to assess the anatomy. However, IOC does also permit the surgeon the potential to intervene if stones are identified.

Research recommendations

Future research should focus on evaluating the learning curve of LUS compared to other techniques to better understand its adoption and proficiency timeline. Additionally, studies with greater statistical power are needed to determine if there are any differences in BDI detection rates between IOC and LUS. Large multicenter studies should also compare these techniques against standard outcomes to provide robust, generalizable evidence.

DISCUSSION

Values and patient perspective

One patient (AL) was interviewed who had undergone a laparoscopic cholecystectomy, for their opinions on outcomes, values, and overall input regarding intraoperative imaging techniques. From the patient’s point of view, the most important factor in choosing an intraoperative imaging technique is the ability to detect bile duct injury or stones early, even if it means a longer surgery or the possibility of an unsuccessful attempt. The patient expressed a clear preference for intraoperative cholangiography for its ability to identify injuries or stones during the index operation, avoiding the need for additional interventions or reoperations later. Potential downsides such as longer operative time, minor radiation exposure, or a small risk of side effects were not viewed as concerning. The patient emphasized that avoiding complications and not needing to return to the hospital are key aspects.

Dissemination

This guideline will be available for review at sages.org.

Implementation

The panel believes that it is potentially feasible to successfully implement these recommendations into local practice and that the recommendations will be accepted by stakeholders. One potential limitation will be the availability of all the different technologies as well as the additional staff to operate the C arm to perform intraoperative cholangiography. Additionally, fluoroscopy licensing requirements in some states may be a barrier for some providers and prevent them from utilizing IOC during cholecystectomy. Fluorescence capable equipment is not available at all centers. Finally, shortages of materials such as ICG and contrast may affect the ability to utilize intraoperative imaging techniques.

Updating these guidelines

After publication of these guidelines, the SAGES Living Guidelines Taskforce will plan to repeat the literature search at a 3-year interval to identify new evidence. If the updated literature search detects high-quality, new literature, a formal update of these guidelines will be performed. Particular attention will be given to future studies that address the research recommendations proposed in this guideline.

Health equity

Non-white, publicly insured, and uninsured patients are more likely to undergo laparoscopic cholecystectomy in an acute, rather than elective, setting [16, 17]. Hospital systems should make every effort to ensure that these intraoperative imaging technologies are as accessible for overnight and weekend acute care cases as they are during elective cases to ensure that these populations are receiving the same standard of care.

Limitations of these guidelines

While the panel was composed of experienced surgeons who regularly perform laparoscopic cholecystectomy, these guidelines are nonetheless limited by the lack of significant patient input on the importance of the various outcomes.

The low level of evidence available across KQs is also a significant limitation. Many times, outcomes the panels deemed critical had no direct, comparative evidence. RCTs are optimal for many of these questions, as statistical methods to control for baseline differences in observational studies will likely be insufficient to fairly compare two fundamentally different groups. However, if we rely solely on RCTs it is unlikely we will amass sufficiently large patient populations to understand rare but important outcomes like BDI.

What others are saying

The Safe Cholecystectomy Multi-Society Practice Guideline and State of the Art Consensus Conference on Prevention of Bile Duct Injury During Cholecystectomy was a collaboration between SAGES, Americas Hepato-Pancreato-Biliary Association, International Hepato-Pancreato-Biliary Association, Society for Surgery of the Alimentary Tract, and European Association for Endoscopic Surgery published in 2020 [18]. Similar to this guideline, they state, “In patients with acute cholecystitis or a history of acute cholecystitis, we suggest the liberal use of intraoperative cholangiography (IOC) during laparoscopic cholecystectomy to mitigate the risk of bile duct injury (conditional recommendation, very low certainty of evidence). Surgeons with appropriate experience and training may use laparoscopic ultrasound imaging as an alternative to IOC during laparoscopic cholecystectomy. In patients with uncertainty of biliary anatomy or suspicion of bile duct injury during laparoscopic cholecystectomy, we recommend that surgeons use intraoperative biliary imaging (in particular intraoperative cholangiography) to mitigate the risk of bile duct injury (strong recommendation, very low certainty of evidence).”

Conclusion

This guideline makes conditional recommendations in favor of utilizing IOC over no intraoperative imaging technique, routine IOC over selective IOC, IOC over FI with ICG, and either FI with ICG or LUS during laparoscopic cholecystectomy. These recommendations highlight the importance of continuing to train general surgery residents in these techniques

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: Funding for the methodologist, librarian, statistician, and guidelines fellow was supported by the SAGES Education and Research Foundation (SERF) grant. 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.

Declarations/Disclosures: Dr. Sunjay Kumar and Dr. Dena Shehata are research fellows whose salaries are supported by SAGES. Dr. Romeo Ignacio is a

research consultant for Critical Innovations and holds publicly available stocks in AbbVie and Abbott Laboratories. Dr. Matthew Bloom is a consultant for Boston Scientific. Dr. Philip H. Pucher is a consultant for Intuitive Surgical, Inc. Dr. Peter T. Hallowell is President of the Midwest Surgical Association. Dr. Bethany Slater is Chair of the Guidelines Committee for SAGES and a consultant for Cook Medical and Hologic. Drs. Jeffrey Chiu, Brian R. Davis, Marian McDonald, Subhashini Ayloo, Ali Kchaou, Georgios Orthopoulos, Uretz Oliphant, Federico Serrot, David Wayne Overby, Eduardo Moreno-Paquentin, and Emily Miraflor have no conflicts of interest to declare.

APPENDICES

REFERENCES

1. Unalp-Arida A, Constance ER (2022) The burden of gallstone disease in the United States population. medRxiv. doi:10.1101/2022.07.08.22277386
2. Connor S, Garden OJ (2006) Bile duct injury in the era of laparoscopic cholecystectomy. Br J Surg 93:158-168. doi:10.1002/bjs.5266
3. Alexander HC, Bartlett AS, Wells CI, Hannam JA, Moore MR, Poole GH, Merry AF (2018) Reporting of complications after laparoscopic cholecystectomy: a systematic review. HPB (Oxford) 20:786–794. doi:/10. 1016/j. hpb. 2018. 03. 004
4. Strasberg SM, Brunt LM (2010) Rationale and use of the critical view of safety in laparoscopic cholecystectomy. J Am Coll Surg 211:132-138. doi:10.1016/j.jamcollsurg.2010.02.053
5. Kuster GG, Gilroy S, Graefen M (1993) Intraoperative cholangiography for laparoscopic cholecystectomy. Surg Gynecol Obstet 176:411-417. PMID: 8480262.
6. Ishizawa T, Tamura S, Masuda K, Aoki T, Hasegawa K, Imamura H, Beck Y, Kokudo N (2009) Intraoperative fluorescent cholangiography using indocyanine green: a biliary road map for safe surgery. J Am Coll Surg 208:e1–e4.  doi:10.1016/j.jamcollsurg.2008.09.024
7. Birth M, Ehlers KU, Delinikolas K, Weiser HF (1998) Prospective randomized comparison of laparoscopic ultrasonography using a flexible-tip ultrasound probe and intraoperative dynamic cholangiography during laparoscopic cholecystectomy. Surg Endosc 12:30-36. doi:10.1007/s004649900587.
8. Rogers AT, Dirks R, Burt HA, Haggerty S, Kohn GP, Slater BJ, Walsh D, Stefanidis D, Pryor A (2021) Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) guidelines development: standard operating procedure. Surg Endosc 35:2417-2427.  doi: 10.1007/s00464-021-08469-z
9. Alonso-Coello P, Schünemann HJ, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Rada G, Rosenbaum S, Morelli A, Guyatt GH, Oxman AD; GRADE Working Group (2016) GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction. BMJ 353:i2016. doi:10.1136/bmj.i2016
10. Alonso-Coello P, Oxman AD, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Vandvik PO, Meerpohl J, Guyatt GH, Schünemann HJ; GRADE Working Group (2016) GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines. BMJ 353:i2089. doi:10.1136/bmj.i2089
11. GRADEpro (2015) GRADEpro GDT: GRADEpro Guideline Development Tool. [Software]. McMaster University, (developed by Evidence Prime, Inc.), Available from http://gradepro.org
12. Chen Y, Yang K, Marušic A, Qaseem A, Meerpohl JJ, Flottorp S, Akl EA, Schünemann HJ, Chan ESY, Falck-Ytter Y, Ahmed F, Barber S, Chen C, Zhang M, Xu B, Tian J, Song F, Shang H, Tang K, Wang Q, Norris SL (2017) A Reporting Tool for Practice Guidelines in Health Care: The RIGHT Statement. Ann Intern Med. 166:128-132. doi:10.7326/M16-1565
13. Wells GA, Shea B, O’Connell D, Peterson J, Welch V, Losos M, Tugwell P. (2009) The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomized studies in meta-analyses. Available from: http://www.ohri.ca/programs/clinical_epidemiology/oxford.htm [cited 2009 Oct 19].
14. Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, Cates CJ, Cheng HY, Corbett MS, Eldridge SM, Emberson JR, Hernán MA, Hopewell S, Hróbjartsson A, Junqueira DR, Jüni P, Kirkham JJ, Lasserson T, Li T, McAleenan A, Reeves BC, Shepperd S, Shrier I, Stewart LA, Tilling K, White IR, Whiting PF, Higgins JPT (2019) RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ 366:l4898. doi:10.1136/bmj.l4898
15. Hong J, Kumar S, Akram I, Khan SR, Cetrulo LN, Ignacio R, Chiu J, Davis B, McDonald M, Ayloo S, Kchaou A, Overby D, Shehata DG, Moreno-Paquentin E, Slater BJ, Miraflor E (2025) Intraoperative imaging of the common bile duct: a systematic review. Surg Endosc 39:4716-4751. doi:10.1007/s00464-025-11898-9
16. Abdelaal A, El-Matbouly M, Sulieman I, Alshahri M, Almazeedi S, Al-Sabah S (2017) Role of intraoperative cholangiography for detecting residual stones after biliary pancreatitis: still useful? A retrospective study. World J Emerg Surg 12:18. doi:10.1186/s13017-017-0130-9
17. Quarmby NM, Vo MT, Gananadha S (2024) Is routine intraoperative cholangiogram necessary in patients with mild acute biliary pancreatitis undergoing index admission cholecystectomy? Am
    Surg 90:2780–2787. doi:10.1177/00031348241250050
18. Gahagan JV, Hanna MH, Whealon MD, Maximus S, Phelan MJ, Lekawa M, Barrios C, Bernal NP (2016) Racial disparities in access and outcomes of cholecystectomy in the United States. Am Surg 82:921-925. doi:10.1177/000313481608201013
19. Janeway MG, Sanchez SE, Rosen AK, Patts G, Allee LC, Lasser KE, Dechert TA (2021) Disparities in Utilization of Ambulatory Cholecystectomy: Results From Three States. J Surg Res 266:373-382. doi:10.1016/j.jss.2021.03.052.
20. Brunt LM, Deziel DJ, Telem DA, Strasberg SM, Aggarwal R, Asbun H, Bonjer J, McDonald M, Alseidi A, Ujiki M, Riall TS, Hammill C, Moulton CA, Pucher PH, Parks RW, Ansari MT, Connor S, Dirks RC, Anderson B, Altieri MS, Tsamalaidze L, Stefanidis D; Prevention of Bile Duct Injury Consensus Work Group (2020) Safe Cholecystectomy Multi-society Practice Guideline and State of the Art Consensus Conference on Prevention of Bile Duct Injury During Cholecystectomy. Ann Surg 272:3-23. doi:10.1097/SLA.0000000000003791

Author Affiliations

Sunjay K. Kumar¹ · Dena G. Shehata² · Lawrence N. Cetrulo³ · Romeo Ignacio⁴ · Jeffrey Chiu⁵ · Brain R. Davis⁶ · Marian McDonald⁷ · Matthew B. Bloom⁸ · Subhashini Ayloo⁹ · Ali Kchaou¹⁰ · Georgios Orthopoulos¹¹ · Philip H. Pucher¹² · Uretz Oliphant¹³ · Peter T. Hallowell¹⁴ · Federico Serrot¹⁵ · David Overby¹⁶ · Eduardo Moreno‑Paquentin¹⁷ · Bethany J. Slater¹⁸ · Emily Miraflor¹⁹

1. Department of Surgery, Thomas Jefferson University Hospital, Philadelphia, PA, USA
2. Department of Surgery, Lahey Hospital and Medical Center, Burlington, MA, USA
3. Department of Surgery, University of Washington School of Medicine, Seattle, WA, USA
4. Division of Pediatric Surgery, Department of Surgery, San Diego School of Medicine, University of California, California, CA, USA
5. Department of Surgery, AdventHealt, Orlando, FL, USA
6. Department of Surgery, Christus Trinity Clinic, Corpus Christi, TX, USA
7. University of Pennsylvania, Philadelphia, PA, USA
8. Department of Surgery, Cedars Sinai Medical Center, Los Angeles, CA, USA
9. Department of Surgery, Aleda E. Lutz VA Medical Center, Saginaw, MI, USA
10. Department of General and Digestive Surgery, Faculty of Medicine, Habib Bourguiba Hospital, University of Sfax, Sfax, Tunisia
11. Department of Surgery, Beth Israel Lahey Health -Winchester Hospital, Winchester, MA, USA
12. Portsmouth Hospitals University NHS Trust, Portsmouth, UK
13. Carle Foundation Hospital, Urbana, IL, USA
14. Division of General Surgery, Department of Surgery, University of Virginia School of Medicine, Charlottesville, VA, USA
15. Department of Surgery, Cleveland Clinic Florida, Weston, FL, USA
16. Department of Surgery, University of North Carolina, Chapel Hill, NC, USA
17. Department of Surgery, ABC Medical Center, Mexico City, Mexico
18. Department of Surgery, University of Chicago, Chicago, IL, USA
19. Department of Surgery, University of California-East Bay, Oakland, CA, USA