Development and Prospective Pilot Validation of the Stanley Bile Duct Injury-Repair Risk Stratification Score for...

Background Bile duct injury (BDI) remains one of the most serious complications of cholecystectomy and frequently necessitates complex biliary reconstruction. Successful reconstruction depends not only on the anatomical severity of injury but also on multiple physiological, clinical, biochemical, and radiological factors. Existing anatomical classification systems describe the level of injury but do not objectively determine readiness for definitive reconstruction or guide its optimal timing. To our knowledge, no preoperative risk stratification score currently exists for this purpose. We developed the Stanley Bile Duct Injury-Repair Risk Stratification Score (Stanley BDI-RRS) to address this unmet clinical need. Methods The Stanley BDI-RRS was developed using a retrospective cohort of patients managed between January 2015 and December 2019. Eight preoperative variables associated with favorable reconstructive outcomes were incorporated into the score: interval from injury to repair ≥6 weeks, absence of vascular injury, bilioma/abscess/biliary fistula, and sepsis/cholangitis, bile duct diameter ≥7 mm, direct bilirubin ≤4.5 mg/dL, serum albumin ≥3.0 g/dL, and Bismuth-Strasberg E1-E2 injuries. A prospective observational internal validation cohort (January 2020-December 2024) included 69 consecutive patients undergoing definitive biliary reconstruction. Patients were assessed using the Stanley BDI-RRS at presentation and, when preoperative optimization was undertaken, reassessed immediately before definitive reconstruction. Results Sixty-nine patients were included (mean age 40.8 years); 59 (85.5%) were female, and 10 (14.5%) were male. At presentation, 49 (71.0%) patients had Stanley BDI-RRS scores ≥6, while 20 (29.0%) had scores <6. Eleven (15.9%) patients underwent preoperative optimization, with 10 improving to scores ≥6 before reconstruction. Patients with final preoperative score ≥6 had few adverse postoperative and long-term outcomes, with no postoperative bile leaks or recurrent biliary strictures and one intra-abdominal collection requiring intervention. In contrast, patients with scores <6 accounted for all three postoperative bile leaks (3/69, 4.3%) and the only recurrent biliary stricture (1/69, 1.4%). Overall, 62 patients (89.9%) had an uneventful recovery. Median hospital stay was eight days (IQR, 7-11), and the 18-month stricture-free rate was 98.6% (68/69). No patients required reoperation for postoperative complications during the study period. Conclusion The Stanley BDI-RRS score is a novel, simple, objective, and clinically applicable tool for preoperative risk stratification before definitive biliary reconstruction following post-cholecystectomy bile duct injury. By integrating eight readily available preoperative variables, it provides an objective assessment of physiological readiness for definitive biliary reconstruction. This study represents the initial prospective pilot validation of the Stanley BDI-RRS score. Further multicenter external validation with longer follow-up is required before widespread clinical adoption.