NCT05436626

Post-cholecystectomy Major Bile Duct Injury

Completed NA Last updated 16 May 2023

What this trial tests

NA trial testing Early BDI reconstruction without abdominal sepsis control in Common Bile Duct Injury in 277 participants. Completed in 31 January 2022.

Timeline

1 February 2014

Primary endpoint
31 January 2022

31 January 2022

Quick facts

Lead sponsor	South Valley University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	277
Start date	1 February 2014
Primary completion	31 January 2022
Estimated completion	31 January 2022

Drugs / interventions tested

• Early BDI reconstruction without abdominal sepsis control
• Early BDI reconstruction with abdominal sepsis control
• Delayed reconstruction

Conditions studied

• Common Bile Duct Injury — all drugs for Common Bile Duct Injury →

Sponsor

South Valley University

Who can join

Adults 20 to 80, any sex, with Common Bile Duct Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Bile duct injury (BDI) is one of the devastating recognized complications of cholecystectomy which does not respect the seniority or experience of the surgeon. It has a disastrous impact on long-term survival, health-related quality of life, and healthcare costs as well as high rates of litigation. The incidence of BDI increased with the introduction of laparoscopic cholecystectomy (LC) with an incidence of around 0.3-1.5%.

The initial aim of BDI is to manage abdominal and biliary sepsis and to transform an acute BDI into a controlled external biliary fistula.

The surgical treatment of postcholecystectomy BDI success depends on many factors as the severity of the injury, the centers and surgeon's experiences, the patient's condition, and the reconstruction time. The optimal time for the reconstruction and the patient's condition remains an active topic of interest and debate. Many papers discussed their impact on the short and long-term outcomes with different conflicting results from different institutions.

Based on the previous data and the absence of guidelines that recommend the timing of BDI reconstruction, the decision for the timing of reconstruction should be based on the predicted success of the operation, costs, and patient quality of life. If comparable morbidity and mortality outcomes can be obtained, patient quality of life and effective use of healthcare resources should be taken into consideration. We hypothesized that inadequate sepsis control and BDI reconstruction can be done safely at any time of presentation.

Our study aimed to present our experience in the management of major post-cholecystectomy BDI with HJ and analyze the impact of both the reconstruction time and the control of sepsis on the BDI reconstruction success rate. By analyzing the results of these three treatment strategies, we can better understand the factors that affect reconstruction success, costs, and health-related quality of life associated with BDI and subsequent repair.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Post-cholecystectomy major bile duct injury: ideal time to repair based on a multicentre randomized controlled trial with promising results.
   Omar MA, Kamal A, Redwan AA, Alansary MN, et al · · 2023 · cited 13× · PMID 37072143 · DOI 10.1097/js9.0000000000000403