Laparoscopic Versus Open Surgical Management of Post Cholecystectomy Bile Duct Injury

Bile Duct Injury Clinical Trial

Official title:

Laparoscopic Versus Open Surgical Management of Post Cholecystectomy Bile Duct Injury

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05243225
• Other study ID #: BDI repair
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Bile Duct Injury
• Postcholecystectomy Syndrome
• Wounds and Injuries

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