NCT04134546

Early Versus Late Intervention After Biliary Tract Injury Post Cholecystectomy

Status unknown NA Last updated 22 October 2019

What this trial tests

NA trial testing CBD exoloration in Biliary Fistula in 30 participants. Status unknown.

Timeline

30 October 2019

Primary endpoint
30 October 2022

30 October 2022

Quick facts

Lead sponsor	Assiut University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	30 October 2019
Primary completion	30 October 2022
Estimated completion	30 October 2022

Drugs / interventions tested

• CBD exoloration

Conditions studied

• Biliary Fistula — all drugs for Biliary Fistula →

Sponsor

Assiut University

Who can join

Eligibility, any sex, with Biliary Fistula. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.