Post-cholecystectomy major bile duct injury: ideal time to repair based on a multicentre randomized controlled trial with promising results

Abstract

Background: Bile duct injury (BDI) is one of the serious complications of cholecystectomy procedures, which has a disastrous impact on long-term survival, health-related quality of life (QoL), healthcare costs as well as high rates of litigation. The standard treatment of major BDI is hepaticojejunostomy (HJ). Surgical outcomes depend on many factors, including the severity of the injury, the surgeons' experiences, the patient's condition, and the reconstruction time. The authors aimed to assess the impact of reconstruction time and abdominal sepsis control on the reconstruction success rate.

Methods: This is a multicenter, multi-arm, parallel-group, randomized trial that included all consecutive patients treated with HJ for major post-cholecystectomy BDI from February 2014 to January 2022. Patients were randomized according to the time of reconstruction by HJ and abdominal sepsis control into group A (early reconstruction without sepsis control), group B (early reconstruction with sepsis control), and group C (delayed reconstruction). The primary outcome was successful reconstruction rate, while blood loss, HJ diameter, operative time, drainage amount, drain and stent duration, postoperative liver function tests, morbidity and mortality, number of admissions and interventions, hospital stay, total cost, and patient QoL were considered secondary outcomes.

Results: Three hundred twenty one patients from three centres were randomized into three groups. Forty-four patients were excluded from the analysis, leaving 277 patients for intention to treat analysis. With univariate analysis, older age, male gender, laparoscopic cholecystectomy, conversion to open cholecystectomy, failure of intraoperative BDI recognition, Strasberg E4 classification, uncontrolled abdominal sepsis, secondary repair, end-to-side anastomosis, diameter of HJ (< 8 mm), non-stented anastomosis, and major complications were risk factors for successful reconstruction. With multivariate analysis, conversion to open cholecystectomy, uncontrolled sepsis, secondary repair, the small diameter of HJ, and non-stented anastomosis were the independent risk factors for the successful reconstruction. Also, group B patients showed decreased admission and intervention rates, decreased hospital stay, decreased total cost, and early improved patient QoL.

Conclusion: Early reconstruction after abdominal sepsis control can be done safely at any time with comparable results for delayed reconstruction in addition to decreased total cost and improved patient QoL.

Trial registration: ClinicalTrials.gov NCT05436626.