Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05243225
Other study ID # BDI repair
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2023
Est. completion date January 2024

Study information

Verified date June 2023
Source Assiut University
Contact amir william samir fahmy, resident
Phone +201119958633
Email amirwilliam8@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Comparison between laparoscopic and open surgical management of post cholecystectomy bile duct injury.


Description:

Bile duct injury (BDI) post cholecystectomy is an iatrogenic catastrophe associated with significant morbidity , mortality and poor quality of life this is due to the large number of cholecystectomies per year all over the world. Cholecystectomy whether open or laparoscopic is done in large number about 750,000 annually in USA, the incidence of BDI post cholecystectomy is about 0.1-0.2% in open cholecystectomy and 0.4-0.6% in laparoscopic cholecystectomy although the percentage appears small but it still large number about 2100 patients per year. The two most frequent scenarios of BDI may be occurrence of bile leak or bile duct obstruction. Early recognition of iatrogenic bile duct injury is essential to prevent major morbidity by imaging techniques, such as Ultrasound and CT which are extremely valuable during the initial evaluation but MRCP remains the gold standard for diagnosis. ERCP can confirm the presence of biliary injury and provides a means for definitive management. The main aim of surgical treatment is the reconstruction of proper flow of bile to the alimentary tract. Repair of such injuries still remains a challenge due to the variety of size of injury, site of injury if proximal or distal, the severity of injury and the time of presentation after the injury. Repair of such BDI may be done by laparoscopy or by open surgery which still a matter of debate. There are many described techniques should be done by specialized hepatobiliary surgeon from simple repair, repair over T-tube up to hepaticojejunostomy. Despite widespread advances in laparoscopic surgery, laparoscopic repair of post-cholecystectomy bile duct injury (BDI) has rarely been reported related mainly to technical difficulty.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date January 2024
Est. primary completion date January 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 80 Years
Eligibility Inclusion Criteria: 1. All patients with post cholecystectomy bile duct injuries admitted to surgery department in Asyut University Hospitals and El-Rajhi hospital at the period of the study. 2. Patients fit for surgery. 3. Patients informed consent for study. 4. Patients with signs and symptoms due to Bile duct injury like abdominal pain, jaundice and high liver function parameters Exclusion Criteria: 1. Unfit cases for laparoscopic surgery. 2. Unfit patients for open surgery. 3. Patients refuse consent to participate in the study. 4. Patients who had previous repair. 5. Patients who present with abdominal sepsis.

Study Design


Intervention

Procedure:
Laparoscopic versus open surgical management of post cholecystectomy bile duct injury
Comparison between laparoscopic and open surgical management of post cholecystectomy bile duct injury.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison between outcomes of laparoscopic and open surgical management of post cholecystectomy bile duct injury. Analysis of efficacy of repair in laparoscopic and open surgical management of post cholecystectomy bile duct injury Baseline
See also
  Status Clinical Trial Phase
Recruiting NCT05169073 - Virtual Reality Training for Laparoscopic Cholecystectomy N/A
Recruiting NCT05709548 - Use of Indocyanine Green in Acute Cholecystitis Phase 4
Completed NCT03673033 - Biliary Complications in Live Donor Liver Transplantation
Completed NCT05479227 - Bile Duct Injuries During Laparoscopic Cholecystectomies: An 11-year Population-based Study
Active, not recruiting NCT06223061 - Global Evaluation of Cholecystectomy Knowledge and Outcomes
Recruiting NCT03716232 - Kaffes Stent in the Management of Post-surgical Biliary Strictures Phase 3
Recruiting NCT02801500 - Superior Bilioenteric Anastomosis by Magnetic Compressive Technique N/A
Recruiting NCT04908826 - Comparison of Icg's Route of Administration During Laparoscopic Cholecystectomy N/A
Recruiting NCT03386201 - FLuorescence Cholangiography Using Methylene Blue N/A
Completed NCT04286763 - Factors Influencing Occurrence Of Hilar Biliary Stricture In Case of Bile Duct Injury
Completed NCT04582240 - Bile Duct Injury Digestif
Recruiting NCT03774589 - Bilioenteric Anastomosis by Magnetic Compressive Technique N/A
Completed NCT05556668 - Percutaneous Biodegradable Biliary Stents for the Treatment of Benign Biliary Strictures.