# A Time-Based and Clinical Status Stratified Protocol for Major Bile Duct Injury After Cholecystectomy: Retrospective, Single-Center Outcomes From a Resource-Limited Setting

## TL;DR

This study shows that waiting 3 months before repairing major bile duct injuries after gallbladder surgery leads to better long-term results, especially in resource-limited settings.

## Contribution

The study introduces a 'physiology-first' protocol showing late delayed repair (≥3 months) improves outcomes for major bile duct injuries.

## Key findings

- Late delayed repair (≥3 months) had a 91.7% success rate compared to 37.5% in critical care patients.
- The two-to-eight-week post-injury period was identified as a high-risk 'danger zone' for reconstruction failure.
- Sepsis/multi-organ failure and high-grade injury were independent predictors of repair failure.

## Abstract

Background

The management of major iatrogenic bile duct injury (BDI) (Strasberg types D and E) is critically influenced by the timing of repair and patient physiology, posing a significant clinical challenge in resource-constrained environments. This study aimed to determine the optimal timing for surgical intervention, identify predictors of repair failure, and evaluate long-term anastomotic patency and postoperative complications in patients undergoing Roux-en-Y hepaticojejunostomy (HJ) for major BDI.

Patients and methods

This study was conducted at Al-Thawra Modern General Hospital in Sana'a, Yemen. In this retrospective cohort study, 54 consecutive patients with major iatrogenic BDI (Strasberg types D and E) were managed between 2014 and 2022 using a "physiology-first" protocol. Patients were stratified into four groups: immediate repair (<72 hours; G1, n = 22), early delayed (two to eight weeks; G2, n = 12), late delayed (≥3 months; G3, n = 12), and a critical care pathway for those presenting with sepsis or multi-organ failure (G4, n = 8). Definitive Roux-en-Y HJ was performed in 49 patients (90.7%), as five patients in G4 died during initial stabilization. The primary outcome was initial technical success. Long-term anastomotic patency survival was analyzed using Kaplan-Meier curves with log-rank testing, and independent predictors of repair failure were identified using multivariate logistic regression.

Results

The mean patient age was 52.4 ± 11.8 years, with a female predominance (66.7%, 36/54). Most injuries occurred during laparoscopic cholecystectomy (94.4%, 51/54), and 38.9% (21/54) were classified as high-grade (Strasberg E3-E5). The overall primary technical success rate was 77.8% (42/54). When stratified by protocol, success rates were 91.7% (11/12) for G3, 86.4% (19/22) for G1, 83.3% (10/12) for G2, and 37.5% (3/8) for G4. Major complications (Clavien-Dindo ≥III) occurred in 16.3% (8/49) of the surgical cohort. Long-term morbidity included anastomotic stricture in 20.4% (10/49), reoperation in 10.2% (5/49), and secondary biliary cirrhosis in 6.1% (3/49). Kaplan-Meier analysis at a median follow-up of 54 months (interquartile range (IQR) 38-58) demonstrated significantly inferior anastomotic patency survival for G2 compared to G3 (16.7% vs. 91.7% event-free; log-rank p < 0.001). Multivariate analysis identified sepsis/multi-organ failure at presentation (adjusted odds ratio (aOR) 10.00, 95% CI 1.26-79.4; p = 0.029) and high-grade injury (aOR 7.14, 95% CI 1.49-34.2; p = 0.014) as independent predictors of failure.

Conclusion

This study validates a "physiology-first" protocol for major iatrogenic BDI, demonstrating superior long-term results with late delayed repair (≥3 months). Crucially, the two-to-eight-week post-injury period was identified as a high-risk "danger zone" for reconstruction failure, challenging traditional early intervention paradigms in suboptimal biological conditions. These findings underscore the necessity of physiological optimization and specialized surgical timing to maximize anastomotic patency and survival, particularly in resource-constrained environments.