Post-cholecystectomy Major Bile Duct Injury
1 other identifier
interventional
277
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2014
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedFirst Submitted
Initial submission to the registry
June 23, 2022
CompletedFirst Posted
Study publicly available on registry
June 29, 2022
CompletedMay 16, 2023
May 1, 2023
8 years
June 23, 2022
May 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reconstruction success rate
The successful reconstruction was defined as the repair with HJ with no further intervention
3 month
Secondary Outcomes (9)
Operative time
5 hours
Blood loss
5 hours
External stent
90 days
Drain-carried time
90 days
Total cost of treatment
6 month
- +4 more secondary outcomes
Study Arms (3)
Early BDI reconstruction without abdominal sepsis control
EXPERIMENTALBDI reconstruction within 6 weeks after the injury without controlling the abdominal sepsis
Early BDI reconstruction with abdominal sepsis control
EXPERIMENTALBDI reconstruction within 6 weeks after the injury after controlling the abdominal sepsis
Delayed reconstruction
ACTIVE COMPARATORBDI reconstruction after 6 weeks after the injury a
Interventions
BDI reconstruction within 6 weeks after the injury without abdominal sepsis control
BDI reconstruction within 6 weeks after the injury with abdominal sepsis control
BDI reconstruction after 6 weeks after the injury
Eligibility Criteria
You may qualify if:
- Patients diagnosed with BDI within 6 weeks after open or laparoscopic cholecystectomy,
- E1 to E4 BDI,
- Failed stenting with endoscopic retrograde cholangiopancreatography (ERCP),
- American Society of Anesthesiologists (ASA) score I-III,
- Agreement to complete the study
You may not qualify if:
- Advanced liver cirrhosis.
- Benign or malignant bile duct stricture.
- concomitant vascular and visceral injury
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Omar MA, Kamal A, Redwan AA, Alansary MN, Ahmed EA. Post-cholecystectomy major bile duct injury: ideal time to repair based on a multicentre randomized controlled trial with promising results. Int J Surg. 2023 May 1;109(5):1208-1221. doi: 10.1097/JS9.0000000000000403.
PMID: 37072143DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohammed A. Omar, Ass. prof.
Faculty of medicine, South Valley University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor of surgery
Study Record Dates
First Submitted
June 23, 2022
First Posted
June 29, 2022
Study Start
February 1, 2014
Primary Completion
January 31, 2022
Study Completion
January 31, 2022
Last Updated
May 16, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share