Early Versus Late Intervention After Biliary Tract Injury Post Cholecystectomy

Bile duct injury following cholecystectomy is an iatrogenic catastrophe associated with significant peri operative morbidity and mortality(1, 2) reduced long term survival(3) and quality of life(4, 5) and high rates of subsequent litigation6. It should be regarded as preventable.

The advent of laparoscopic cholecystectomy has resulted in a resurgence of interest in bile duct injury and its subsequent management. Population based studies(6.7) suggest a significant increase in the incidence of injury (0•1 to 0•5 per cent) following the implementation of the laparoscopic approach(8) Bile duct injury should be regarded as preventable, but over 70 per cent of surgeons regard it as unavoidable(9). Although most injuries occur within the surgeon's first 100 laparoscopic cholecystectomies, one third happen after the surgeon has performed more than 200; it is more than inexperience that leads to bile duct injury(10). It has been suggested that the commonest cause of common bile duct injury is misidentification of biliary anatomy (70-80 per cent of injuries)(11,12),a reduction in risk if surgeons perform routine intraoperative cholangiography Recognition of bile duct injury at the time of cholecystectomy allows an opportunity for the hepatobiliary surgeon to assess its severity and the presence of any vascular injury

Study Overview

• Status: Unknown
• Conditions: Biliary Fistula
• Intervention / Treatment: Procedure: CBD exoloration

Detailed Description

Bile duct injury following cholecystectomy is an iatrogenic catastrophe associated with significant peri operative morbidity and mortality(1, 2) reduced long term survival(3) and quality of life(4, 5) and high rates of subsequent litigation6. It should be regarded as preventable.

The advent of laparoscopic cholecystectomy has resulted in a resurgence of interest in bile duct injury and its subsequent management. Population based studies(6.7) suggest a significant increase in the incidence of injury (0•1 to 0•5 per cent) following the implementation of the laparoscopic approach(8) Bile duct injury should be regarded as preventable, but over 70 per cent of surgeons regard it as unavoidable(9). Although most injuries occur within the surgeon's first 100 laparoscopic cholecystectomies, one third happen after the surgeon has performed more than 200; it is more than inexperience that leads to bile duct injury(10). It has been suggested that the commonest cause of common bile duct injury is misidentification of biliary anatomy (70-80 per cent of injuries)(11,12),a reduction in risk if surgeons perform routine intraoperative cholangiography Recognition of bile duct injury at the time of cholecystectomy allows an opportunity for the hepatobiliary surgeon to assess its severity and the presence of any vascular injury

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients with post cholecystectomy biliary tract injury admitted at Assuit university hospital at the period of the study

Exclusion Criteria:

• Any case with biliary leakage not post cholecystectomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group with biliary injury; group for Early versus late intervention after biliary tract injury post cholecystectomy	Procedure: CBD exoloration; Early versus late intervention after biliary tract injury post cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
faliure of interventon	By mesurment liver functon as direct billirubin	two months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plan for improving	by mesurment of liver function as AST	two months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 30, 2019
• Primary Completion (Anticipated): October 30, 2022
• Study Completion (Anticipated): October 30, 2022

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 18, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 18, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Biliary Tract Diseases; Digestive System Fistula; Fistula; Postcholecystectomy Syndrome; Biliary Fistula
• Other Study ID Numbers: biliary tract injury

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No