SAGES-AHPBA 2025: A Systematic Review and Meta-analysis of Surgical Management of Major Bile Duct Injury following Cholecystectomy

Authors

Ali Esparham¹, Elisa C Calabrese^2,3,4,5, Olivia Ganescu⁵, Sarah Choksi⁶, Kathleen Park⁷, Karan Kumar⁸, Bright Huo⁹, Dena Shehata¹⁰, Ahmed Abou‑Setta¹¹, Ivan Florez^12,13,14, Bethany J Slater¹⁵, Kevin El-Hayek¹⁶

ABSTRACT

Background: Despite ongoing controversies in the management of bile duct injuries (BDIs), current clinical guidance remains limited. To address this gap, a systematic review and meta-analysis were undertaken to clarify and synthesize the available evidence and inform the development of evidence-based recommendations for a forthcoming guideline by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES).

Methodology: A systematic review was conducted, incorporating a comprehensive literature search through December 31, 2024 to address four predefined key questions (KQs) regarding the timing of BDI repair, use of minimally invasive surgery for BDI repair, operative vs non operative management of BDI, and hepaticojejunostomy vs hepaticoduodenostomy for bilioenteric repairs. The review included both randomized controlled trials (RCTs) and comparative observational studies, with meta-analyses performed when appropriate. The review was conducted in accordance with PRISMA 2020 guidelines.

Results: For KQ1, 8 studies showed early repair was associated with higher reoperation (Odds Ratio (OR): 3.31, 95% CI: 1.56–7.03), stricture (OR: 7.41, 95% CI: 2.07–26.52), and mortality (OR: 2.83, 95% CI: 1.15–6.95) rates compared to late repair. For KQ2, one observational study found no differences between MIS and open repair. For KQ3, nonoperative management had higher reoperation (OR: 16.60) and stricture (OR: 2.44) rates compared to operative management. For KQ4, two studies showed no differences between hepaticojejunostomy and hepaticoduodenostomy in stricture or reintervention.

Conclusions: Delayed repair for BDI was found to reduce reoperation, stricture, and mortality rates compared to early repair. MIS and open repair yield similar outcomes, while operative management outperforms non-operative approaches for major BDIs. Hepaticojejunostomy and hepaticoduodenostomy show comparable results.

Keywords: Systematic review · Meta-analysis · Bile duct injury · Endoscopy · Interventional radiology ·
Hepaticojejunostomy · Hepaticoduodenostomy

Introduction

Bile duct injury (BDI) is a serious condition that can occur after laparoscopic or open cholecystectomy. The incidence of BDI ranges from 0.4% to 1.5% in laparoscopic cholecystectomy [1-3]. Notable complications of BDI include postoperative sepsis associated with biliary leak, while cholangitis may manifest in the long term. In severe instances, secondary sclerosing cholangitis may occur, necessitating liver transplantation and resulting in a markedly increased mortality rate [4]. Furthermore, BDI is related to significantly higher hospitalization costs and lower patient quality of life [5].

Treatment of BDI is often customized for each patient, depending on the degree and type of the injury as well as the timing of diagnosis [6]. One of the key factors influencing the timing of BDI reconstruction is the frequent delay in diagnosis. Most BDIs are not identified during cholecystectomy but become apparent postoperatively, often when the patient is already septic, with complications such as infected bilomas, cholangitis, jaundice, hypoalbuminemia, and potential vascular injury [7-9]. Both early and delayed reconstruction approaches for major BDIs have been explored. Some hepatobiliary surgeons recommend postponing surgical repair until sepsis and related complications are under control. Others advocate for early reconstruction alongside sepsis management, citing improved patient quality of life and potentially better surgical outcomes compared to delayed intervention [10-13].

Furthermore, the most recent international consensus advises using the Strasberg classification system to assess the severity of BDIs [14]. When bile duct continuity is preserved, as in type A injuries, non-operative management is typically appropriate [14, 15]. In contrast, complex type E injuries are usually treated with surgical reconstruction [15-17]. Some studies have demonstrated the effectiveness of endoscopic management for type B–D BDIs. However, there is still no consensus on the optimal treatment approach for patients with BDI [18].

Moreover, the intraoperative detection of BDI during laparoscopic cholecystectomy has traditionally prompted conversion to open surgery [19, 20]. Likewise, when the injury is diagnosed postoperatively—particularly in cases of major ductal damage—open surgical repair is typically done [21, 22]. The use of minimally invasive techniques is mainly limited by technical challenges such as dense adhesions, septic collections, and difficulty in identifying key anatomical structures [20, 22]. Nevertheless, recent reports from leading centers highlight the growing use of minimally invasive surgery for BDI repair, showing promising outcomes and potential benefits compared to traditional open approaches [23, 24].

Despite ongoing controversies surrounding the management of BDI, current guidance remains unclear. Therefore, a systematic review and meta-analysis were conducted to evaluate the effectiveness and safety of different management interventions BDI and support the development of evidence-based recommendations for a Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) guideline.

Methods

The current systematic review was done in accordance with the Cochrane Handbook for Systematic Reviews [25]. This manuscript was prepared following recommendations of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines [26]. The standard PICO format (Population, Intervention, Comparison, and Outcomes) was utilized to develop key questions (KQ) to investigate various aspects of BDI management [27].

Key questions (KQs)

• KQ1: Should patients with a known BDI undergo early repair (< 6w) or delayed definitive repair (> 6w)?
• KQ2: Should patients with a known BDI undergo MIS repair or open definitive repair?
• KQ3: Should patients with a known BDI undergo definitive operative management or non-operative management?
• KQ4: Should patients with a known BDI undergoing repair with a bilioenteric anastomosis receive a hepaticojejunostomy or a hepaticoduodenostomy?

A detailed table of the KQs in Patient-Intervention-Comparator-Outcome (PICO) format can be found in Appendix A. In KQ1, early repair was defined as those that underwent definitive repair within 6 weeks of injury and late repair was defined as those that underwent repair after 6 weeks from injury. Outcomes were selected and prioritized as critical and important following GRADE methodology [28]. The outcomes of interest were the same across all key questions. Return to the operating room (OR), mortality (90 days), morbidity (Clavien Dindo III&IV), quality of life, and stricture/cholangitis/leak were voted critical outcomes. Reintervention for failure (endoscopic and radiologic), length of stay, and conversion to open were voted important.

Literature search and eligibility criteria

A professional librarian conducted a comprehensive search of Pubmed (via NCBI), Embase (via Elsevier), Cochrane Library (via Cochrane) and CINAHL through December 31, 2024. Additional searches were performed on http://clinicaltrials.gov (via NLM) [29] to identify any unpublished literature and ongoing trials. Included articles were human studies on BDI cases acquired during cholecystectomy, published in English. The BDIs had to be classified as Strasberg B-E, Strasberg A excluded, and repairs had to be definitive with no previous definitive repair attempts (exception if <10% of cases). Previous non-operative intervention and damage control surgery was allowed. Eligible study designs for all KQs included comparative randomized controlled trials (RCTs), cohort studies, case-control and case series studies. Single-arm studies were not considered. Previous definitive search records were first screened for duplicates manually, then uploaded to the Covidence platform [30], where additional duplicates were automatically removed during the import process. A full search strategy can be found in Appendix B.

Study selection

The calibration among reviewers was performed through the evaluation of 50 abstracts using Abstrackr (Brown University, Providence, Rhode Island) and address any scoring disparities on a planned conference call. After this calibration, the retrieved citations were screened for relevance and eligibility by at least two reviewers (A.E., O.G., S.C., K.P., K.K., E.C., D.S., K.E.) utilizing Covidence platform, and studies that did not meet the eligibility criteria defined by the PICO elements were excluded. Afterwards, the remaining articles underwent full text assessment, which were reviewed by two reviewers (A.E., O.G., S.C., K.P., K.K., E.C., D.S., K.E.) to define their final inclusion. A third reviewer resolved any discrepancies during the screening and the full text review process. In addition, reference lists of previously published systematic reviews were meticulously examined to identify any missing relevant studies.

Risk of Bias

The risk of bias (RoB) was assessed for all included studies using the Cochrane RoB 2.0 tool for RCTs and the Newcastle-Ottawa Scale (NOS) for observational studies [31, 32]. The Cochrane RoB 2.0 divides assessment into five domains evaluating the study’s process for randomization, deviations from intended interventions, missing outcome data, measurement of their outcomes, and selection of reported results [32]. The NOS tool uses three domains evaluating a cohort study’s process for selection, comparability, and outcome reporting [31]. Each study was independently assessed by two reviewers (A.E., O.G., S.C., K.P., K.K., E.C., D.S., K.E.). Discrepancies were resolved by reviewer discussion or, if needed, a third-party.

Data extraction

Data extraction forms for the included studies were completed using the Covidence platform. These forms captured information on study characteristics, methods, population, interventions, and outcomes. Two independent reviewers extracted data (A.E., O.G., S.C., K.P., K.K., E.C., D.S., K.E.) . Outcomes of interest included reoperation, endoscopic reintervention, length of stay, morbidity (Clavien Dindo III-IV), stricture, leak, cholangitis, and mortality (90 days).

Data analysis

We conducted a random-effects meta-analysis using RevMan software (Version 5.4.1). We considered the following subgroups a priori to explore potential effect modification with the aim of conducting subgroup analysis: vascular injury and intraoperative repair. We could not conduct subgroup analysis on vascular injury due to a lack of data; however, we were able to conduct subgroup analysis on intraoperative repair. A sensitivity analysis was also planned following ideal methods to potentially exclude studies with high RoB. However, this was not possible as most of the studies included in the analysis were high RoB. We conducted pooled estimates separately by RCTs and observational studies.  We estimated pooled relative risk (RR) for binary outcomes from RCTs, odds ratios (OR) for binary outcomes from observational studies, and a mean difference for continuous outcomes. Heterogeneity between studies was quantified using the I² statistic, and statistical significance was assessed using the Chi² test. Although all the comparative research, encompassing observational studies and those with a high RoB, are included, the results and conclusions emphasize low RoB studies. All analyses were supervised, reviewed, and revised by a statistician (A.A.) experienced in both evidence synthesis and systematic reviews.

Determining certainty of evidence

After synthesis, the Certainty of Evidence (CoE) was determined using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach through the GRADEpro guideline development tool [33–35]. For each outcome, Certainty of Evidence (CoE), also called quality of evidence, was determined by evaluating the risk of bias, inconsistency, indirectness, and imprecision of the included studies [36–39]. Too few studies were available to graphically or statistically assess publication bias. The level of certainty was downgraded if there were concerns in any of these domains. Methods outlined in the GRADE handbook were used to judge the certainty of evidence for each outcome of interest [40]. The evidence tables for each key question are provided in Appendix C. Table 1 presents the certainty of evidence levels and their interpretation.

Table 1: Key Question 1 Study Characteristics

Results

A total of 978 articles were identified in the systematic search of databases after excluding duplicates. 565 articles were excluded during title and abstract screening, and 413 articles were assessed by full text. Of these 385 were excluded and 28 were determined eligible for extraction. Appendix D shows the PRISMA flowchart and Appendix E shows a list of excluded studies with the reasoning [26].

Key Question 1: Should patients with a known BDI undergo early repair (< 6w) or delayed definitive repair (> 6w)?

A total of 17 studies were considered for this question, of which 9 were excluded (see Appendix E for rationale), leaving one RCT and seven observational studies included for analysis [7, 11, 41-46]. Figure 1 represents the RoB assessment of all the observational studies included and Figure 2 for the RCT.

All the included studies were considered high RoB; however, this did vary slightly depending on the outcome. The RCT was deemed high RoB due to a near 20% dropout rate in one of the study arms [46]. Table 2 provides the characteristics of each included study which details the design, country, and sample size. It also includes the time periods compared in the study, the percentage of patients that had previous attempted repair and intraoperative repair, as well as the follow-up period.

Table 2. Key Question 1 Study Characteristics

Reoperation

Four observational studies compared early and late repair of BDI and reported reoperation rates [7, 11, 44, 45]. In the pooled analysis of observational studies, early repair was associated with a significantly higher rate of reoperation compared to late repair (OR: 3.31 [95% CI: 1.56, 7.03], I²: 59%; Very Low CoE) (Fig. 3). In addition, in the pooled analysis of two studies that used intraoperative repair [11, 36], the rate of reoperation was significantly higher in the early repair compared to late repair (OR: 17.93 [95% CI: 8.79, 36.57], I²: 0%; Very Low CoE) (Fig. 3).

Endoscopic reintervention

One RCT [46] and six observational studies [7, 11, 41, 43-45] compared endoscopic reintervention after early versus late repair. There was no significant difference in the rate of endoscopic reintervention between the two groups in both RCT (OR: 1.35 [95% CI: 0.72, 2.51]; very low CoE) and observation studies (OR: 2.73 [95% CI: 0.92, 8.07], I²=70%; very low CoE). However, in the subgroup analysis of studies that performed intraoperative repair [11, 36], early repair was associated with a significantly higher rate of endoscopic reintervention (OR: 12.51 [95% CI: 2.69, 58.19], I²=0%, very low CoE) (Fig. 4).

Length of Stay

Length of stay was reported by one RCT and one observational study [7, 46]. In the RCT by Omar et al., length of stay was significantly longer after late repair compared to early repair (mean difference (MD): -6.00 [95% CI: -8.50, -3.50]; Low CoE) (Fig. 5). However, the observational study showed that early repair had a significantly longer length of stay compared to late repair (MD: 1.30 [95% CI: 0.60, 2.00]; Very Low CoE) (Fig. 5). The RCT Omar et al. had low certainty of evidence, while El Nakeeb et al. had very low certainty of evidence, therefore making the RCT more reliable when interpreting this outcome data.

Morbidity – Clavien Dindo III-IV

One RCT and one observational study compared the rate of morbidity after BDI repair [45, 46].  The rate of morbidity was not significantly different in both RCT (OR: 1.14 [95% CI: 0.64, 2.02]; very low CoE), and the observational study (OR: 0.87 [95% CI: 0.56, 1.36]; very low CoE) (Fig. 6).

Stricture

The rate of stricture after BDI repair was compared in one RCT and four observational studies [41-44, 46]. The RCT study did not show a significant difference between early and late repair for stricture rate (OR: 1.60 [0.57, 4.45]; very low CoE) (Fig. 7). However, the pooled analysis of observational studies demonstrated a significantly higher rate of stricture in early repair compared to late repair (OR: 7.41 [95% CI: 2.07, 26.52], I²: 0%; very low CoE) (Fig. 7). Importantly, the observational studies demonstrated higher precision in the data and also included studies with over five years of outcome data, far more than the RCT which had an average follow-up of 25 months.

Leak

One RCT and two observational studies compared the rate of leak after BDI repair between early repair and late repair [7, 43, 46]. The RCT study did not show a significant difference in the rate of leak between the two groups (OR: 2.56 [95% CI: 0.73, 8.99]; very low CoE) (Fig. 8). In addition, the pooled analysis of two observational studies showed no significant difference in the rate of leak between the two groups (OR: 2.59 [95% CI: 0.89, 7.51], I²: 25%; very low CoE) (Fig. 8).

Cholangitis

The rate of cholangitis was compared in one RCT and three observational studies [7, 11, 43, 46]. The RCT study did not show a significant difference in the rate of cholangitis between early repair and late repair (OR: 1.97 [95% CI: 0.42, 9.32]; very low CoE) (Fig. 9). Moreover, in the pooled analysis of three observational studies, the rate of cholangitis was not significantly different between the two groups (OR: 1.98 [95% CI: 0.30, 13.06], I²:88%; very low CoE) (Fig. 9).

Mortality

One RCT and five observational studies compared the rate of mortality after BDI repair between early repair and late repair [7, 11, 41, 43, 45, 46]. The RCT study did not show a significant difference between the two groups (OR: 1.74 [95% CI: 0.36, 8.38]; very low CoE) (Fig. 10). However, in the pooled analysis of observational studies, the early repair group was associated with a significantly higher rate of mortality compared to the late repair (OR: 2.83 [95% CI: 1.15, 6.95], I²: 0%; very low CoE) (Fig. 10).

Quality of life

Quality of life was compared in one RCT [46], using the EQ-5D instrument [47] and did not demonstrate a significant difference between early and late repair (MD: -0.03 [95% CI: -0.07, 0.01]; Moderate CoE) (Fig. 11).

Key Question 2: Should patients with a known BDI undergo MIS repair or open definitive repair?

Only one study was included for this question [48]. Figure 12 represents the RoB for the study, which was deemed high overall. In addition, the groups that were compared were all intraoperative, during the index cholecystectomy, where a decision was made to continue with MIS or convert to open. This limits the reach of this data to inform those receiving MIS or open repair for BDIs detected post-operatively. Table 3 provides the details of this study including design, country, sample size, percentage with previous attempted repair and follow-up period.

Table 3. Key Question 2 Study Characteristics

Endoscopic reintervention

Tantia et al. (2008) did not show evidence of a significant rate of endoscopic reintervention between MIS and open repair in patients with BDI (OR: 0.25 [95% CI: 0.01, 6.82]; very low CoE) (Fig. 13) [48].

Stricture

As reported by Tantia et al. (2008), the rate of stricture was not significantly different between MIS and open repair in patients with BDI (OR: 0.13 [95% CI: 0.01, ]; very low CoE) (Fig. 14) [48].

Cholangitis

Tantia et al. (2008) showed no evidence of a significant difference
in the rate of cholangitis between MIS and open repair in patients with BDI (OR: 0.13 [95% CI: 0.01, 3.11]; very low CoE) (Fig. 15) [48].

Key Question 3: Should patients with a known BDI undergo definitive operative management or nonoperative management?

A total of 10 studies were considered for this question, of which 2 were excluded (see Appendix E for rationale), leaving 8 observational studies included for analysis [15, 48-54]. Figure 16 represents the RoB for each study. Table 4 provides study characteristics including study design, Strasberg classification, percentage with previous attempted repair, follow-up, percentage with vascular injury, and percentage with sepsis as well.

Table 4. Key Question 3 Study Characteristics

Reoperation

The pooled analysis of three observational studies showed that endoscopic treatment was associated with a significantly higher rate of reoperation compared to surgical treatment (OR: 16.60 [95% CI: 2.28, 120.94], I²:22%; Low CoE) (Fig. 17) [52–54].

Endoscopic reintervention

Two studies compared the rate of endoscopic reintervention between endoscopic and surgical treatment of BDI [48, 53]. The result of pooled analysis was not significantly different between the two treatment approaches (OR: 2.09 [95% CI: 0.20, 22.29], I²=0%; very low CoE) (Fig. 18).

Stricture

Endoscopic treatment of BDI was associated with a significantly higher rate of stricture compared to surgical treatment in the pooled analysis of eight studies (OR: 2.44 [95% CI: 1.45, 4.09], I²:0%; Low CoE) (Fig. 19) [15, 48–54].

Cholangitis

Cholangitis was compared between endoscopic and surgical treatment of BDI in only one study. Tantia et al. (2008) showed no significant difference in the rate of cholangitis between the two treatment approaches (OR: 0.82 [95% CI: 0.03, 20.30]; very low CoE) (Fig. 20) [48].

Mortality

A pooled analysis of three studies showed that the rate of mortality was not significantly different between endoscopic and surgical treatment of BDI (OR: 0.18 [95% CI: 0.03, 1.10], I²: 0; very low CoE) (Fig. 21) [49, 51, 54].

Key Question 4: Should patients with a known BDI undergoing repair with a bilioenteric anastomosis receive a hepaticojejunostomy or a hepaticoduodenostomy?

A total of 3 studies were considered for this question, of which one was excluded (see Appendix E for rationale), leaving two observational studies included for analysis [55, 56]. Figure 22 represents the RoB for each study. Table 2 provides study characteristics including study design, Strasberg classification, percentage with previous attempted repair, follow-up, percentage with vascular injury and percentage with sepsis.

Table 5. Key Question 4 Study Characteristics

Endoscopic reintervention

The rate of endoscopic reintervention was reported in only one study. Moraca et al. (2002) did not show evidence of a significant rate of endoscopic reintervention between hepaticojejunostomy or hepaticoduodenostomy groups (OR: 2.85 [95% CI: 0.13, 64.89]; very low CoE) (Fig. 23) [55].

Stricture

A pooled analysis of two studies showed no evidence of a
significant difference between hepaticojejunostomy or hepaticoduodenostomy groups in the rate of stricture (OR: 1.59 [95% CI: 0.16, 15.40]; very low CoE) (Fig. 24) [55, 56].

Discussion

In the current systematic review and meta-analysis, we assessed the optimal management strategies for patients with BDI following cholecystectomy, focusing on timing of repair, surgical approach, operative versus nonoperative management, and type of bilioenteric anastomosis.

Overview of findings

Our results suggest that early repair may be associated with an increased rate of reoperation and stricture compared to late repair. Mortality also seems to be higher with early repair in observational data (KQ1). Our analysis also showed that a MIS approach may make little to no difference in outcomes when compared to the open approach for BDI repair (KQ2). Furthermore, nonoperative management may be associated with a higher rate of reoperation and stricture compared to operative management of BDI (KQ3). In addition, the outcomes of BDI repair did not seem to be significantly different between hepaticojejunostomy and hepaticoduodenostomy anastomosis approaches (KQ4).

Relationship to the literature

The appropriate time for the BDI repair remains a topic of debate. A previous meta-analysis by Schreuder et al. (2020) on 21 studies showed that delayed BDI repair (> 6 weeks) was associated with a lower rate of stricture compared to early and intermediate repair. In addition, postoperative morbidity was significantly higher in the intermediate interval (2-6 weeks) compared to early and late repair [6]. Furthermore, another meta-analysis by Wang et al. (2020) on 32 studies showed that at the six-week cutoff, early repair correlated with elevated rates of biliary stricture (OR 6.23), surgical complications (OR 2.18), and repair failure (OR 4.03) [16]. In addition, an individual patient data meta-analysis suggested that an immediate repair strategy, which encompasses on-table repair, increases the risk of treatment failure. Conversely, the late approach exhibited the lowest failure rate [57].

In comparison to the aforementioned meta-analysis we evaluated the timing of BDI repair and provided subgroup analysis for immediate repairs, separate from early repair. Further, our data was collected through the year 2024, making it the most up to date compared to previous. We also provided a wide range of outcomes, with patient preference considered. Additionally, our scope in management goes beyond timing of repair with key questions and analysis evaluating surgical techniques, and nonoperative modalities considered. This allows for a more comprehensive evaluation of BDI management and may better reflect real-world considerations in decision-making.

The rationale for the advantageous outcomes of delayed repair is to diminish the risks linked to extensive reconstructive surgery by alleviating inflammation, improving nutritional status, restoring adequate immunologic competence, and facilitating an accurate evaluation of the extent of ischemic injury in conjunction with associated vascular injuries [16, 58].

One important factor to consider is that surgical expertise and proficiency are vital components of successful repair [6, 57]. A focused analysis of patients undergoing bile duct injury correction at specialized HPB centers was conducted by Wang et al.  They observed a lower rate of repair failure for on-table repairs compared to postoperative repairs (18.9% vs. 24.7%), albeit not statistically significant. The authors concluded that the prospective advantages of on-table repair may be obscured by the fact that early repairs are more frequently attempted by non-HPB specialists [16].

Although prior studies have indicated the safety and feasibility of the minimally invasive technique for BDI repair, its present role in the surgical protocol remains anecdotal. The literature on this subject is scarce, and just one study was incorporated into our analysis [59]. A systematic review of 13 papers encompassing 198 patients revealed that the majority had laparoscopic (63.1%) or robotic (36.9%) biliary anastomosis for severe bile duct injury. No conversions to open surgery occurred in the robotic instances, whereas four conversions were noted in the laparoscopic group. The average operating duration ranged from 190 to 330 minutes, with a mean blood loss of 135.9 mL, and the mean postoperative hospital stay was 6.3 days, exhibiting comparable morbidity rates for both methods [59]. However, there is still a lack of high-quality studies on this subject to draw a conclusion.

Endoscopic and radiologic interventions are other treatment approaches for BDIs. In the current study on patients with major BDI, our results showed that nonoperative management was correlated with an elevated incidence of reoperation and stricture in comparison to operative management of BDI. However, a previous individual patient data systematic review showed that the “upfront surgery” group had significantly greater rates of treatment failure and mortality compared to the “upfront endoscopy/radiologic interventions” group [57]. They recognize that elevated conversion rates to open procedures, primarily due to BDI recognition, substantial damage patterns with associated vascular impairment, early injury diagnosis, and subsequent immediate repair attempts in non-specialized centers, emerged as significant baseline variables in the surgical cohort [57].

Hepaticojejunostomy is the gold standard anastomosis approach for patients with major BDI [17]. On the other hand, the hepaticoduodenostomy is a simpler anastomosis that connects the bile duct directly to the duodenum [60]. Although our study showed no significant difference between these two approaches in patients with major BDI, there is a lack of high-quality studies on this subject. In a previous study on patients with benign biliary diseases, it was shown that while short-term complication rates were similar, patients undergoing choledochoduodenostomy experienced a higher incidence of anastomotic strictures compared to hepaticojejunostomy [61].

 Strengths and limitations

Our findings should be interpreted considering the following limitations. First, for many of the KQs, the available data had low or very low certainty of evidence largely due to high RoB and imprecision, all of which weakened the strength of the results. Furthermore, there was significant statistical heterogeneity across numerous outcomes, most likely reflecting differences in surgical technique, patient selection, and study design. The low and very low certainty of evidence results in variability when interpreting the pooled estimates.

There are several strengths to our study. We conducted pooled estimates separately by RCTs and observational studies to facilitate a more reliable interpretation of the data when applicable. While there were many outcomes that resulted in very low certainty of evidence regardless of the study design, the RCT had serious RoB compared to the very serious RoB in the observational studies, therefore, their separation in the pooled analysis for KQ1 helps mitigate some additional uncertainty. Our review is based on meta-analysis that included subgroup analysis. We followed Cochrane methods for systematic reviews and used PRISMA to present this report. Lastly, GRADE was used to determine the certainty of evidence and provide a transparent methodology in appraising the evidence.  

Relevance to clinical practice and future research recommendations

The observation that early repairs are associated with higher rates of reoperation, stricture, and mortality compared to late repairs (KQ1) may suggest that, when feasible, delaying definitive repair until inflammation has resolved may improve outcomes. This aligns with current practice trends favoring delayed reconstruction in select cases. Additionally, the lack of significant outcome differences between open and MIS approaches for BDI repair (KQ2) indicates that MIS techniques may be a viable alternative for appropriately selected patients. Furthermore, our analysis may indicate that nonoperative management is associated with a higher risk of reoperation and stricture formation compared to operative management (KQ3), reinforcing the importance of surgical intervention for patients with major BDI. Finally, the finding that outcomes are similar between hepaticojejunostomy and hepaticoduodenostomy (KQ4) may provide surgeons with greater flexibility in selecting the most appropriate anastomotic technique based on patient anatomy, intraoperative findings, and surgeon preference.

Future research should focus on high-quality, prospective studies and RCTs to better define the optimal timing and technique for BDI repair, as well as to explore the long-term functional outcomes and quality of life in this patient population [25, 26, 53].

Conclusion

This systematic review and meta-analysis highlight several key findings in the management of major BDI. Early repairs may be associated with higher rates of reoperation, stricture, and mortality compared to late repairs, suggesting that delaying definitive reconstruction when clinically appropriate may improve outcomes. While MIS approaches for BDI repair may have comparable outcomes to open surgery, the choice of technique should be tailored to the patient’s condition and the surgeon’s expertise. Nonoperative management may be linked to increased reoperation and stricture rates, supporting the role of timely surgical intervention in patients with major BDI. Additionally, it seems no significant differences were observed between hepaticojejunostomy and hepaticoduodenostomy for BDI reconstruction, providing flexibility in an anastomotic approach. However, the current evidence is limited by the low to very low certainty of evidence, underscoring the need for well-designed prospective trials and more robust comparative data.

Acknowledgements: We would like to thank Sarah Colón, the SAGES senior program coordinator, and Holly Ann Burt, the SAGES librarian for their help with the creation of this systematic review.

Funding Funding support for the methodologist, research librarians, statistician, and the guidelines fellows came from SAGES Education and Research Fund 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 conflicts of interest and financial ties were declared by the authors. All potential conflicts were reviewed and none influenced the design, analysis, or interpretation of the research presented in this manuscript. Elisa C. Calabrese is a funded research fellow by the SAGES Education and Research Foundation (SERF) grant and by the RACS Foundation for Surgery. Dr. Dena Shehata is a guidelines research fellow and funded by the SERF grant. Ahmed Abou-Setta and Ivan D Florez are both paid consultants for SAGES. Dr. Bethany J Slater is the SAGES Guidelines Committee Chair and receives consulting consulting fees from Hologic. Olivia Ganescu, Sarah Choksi, Kathleen Park, Karan Kumar, Bright Huo, and Kevin El-Hayek have no disclosures.

Ethics approval : Not applicable.

Patient consent statement: Not applicable

APPENDICIES

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Author Affiliations

Ali Esparham¹, Elisa C Calabrese^2-5, Olivia Ganescu⁵, Sarah Choksi⁶, Kathleen Park⁷, Karan Kumar⁸, Bright Huo⁹, Dena Shehata¹⁰, Ahmed Abou‑Setta¹¹, Ivan Florez^12,13,14, Bethany J Slater¹⁵, Kevin El-Hayek¹⁶

1. Mashhad University of Medical Sciences, Mashhad, Iran
2. Department of Surgery, University of California-East Bay, Oakland, CA, USA
3. Department of Surgery, University of Adelaide, The Queen Elizabeth Hospital, Adelaide, SA, AU
4. Research, Audit & Academic Surgery, Royal Australasian College of Surgeons, Adelaide, SA, AU
5. Division of General Surgery, McGill University Health Centre, Montreal, QC, Canada
6. Department of General Surgery, Albany Medical Center, Albany, NY, USA
7. Department of Surgery, Robert Wood Johnson Rutgers University Hospital, New Brunswick, New Jersey, USA
8. Department of General Surgery, Nuvance Health, Danbury, CT, USA
9. Division of General Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada
10. Department of Surgery, Lahey Hospital and Medical Center, Burlington, MA, USA
11. Department of Community Health Sciences, University of Manitoba, Winnipeg, MB, Canada
12. Department of Pediatrics, University of Antioquia, Medellin, Colombia
13. School of Rehabilitation Science, Mcmaster University, Hamilton, ON, Canada
14. Pediatric Intensive Care Unit, Clinica Las Americas, Medellin, Colombia
15. Mount Sinai Kravis Children’s Hospital, New York, NY, USA
16. Department of Surgery, The MetroHealth System, Case Western Reserve University School of Medicine, Cleveland, OH, USA

Corresponding author: Elisa C Calabrese Oakland, California 94602