Early Versus Late Intervention After Biliary Tract Injury Post Cholecystectomy

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04134546
Collaborator
(none)
30
1
36

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: CBD exoloration
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Early Versus Late Intervention After Biliary Tract Injury Post Cholecystectomy
Anticipated Study Start Date :
Oct 30, 2019
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. faliure of interventon [two months]

    By mesurment liver functon as direct billirubin

Secondary Outcome Measures

  1. plan for improving [two months]

    by mesurment of liver function as AST

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bassem Barghoth Sabet Amin, resident doctor at general surgery department, Assiut University
ClinicalTrials.gov Identifier:
NCT04134546
Other Study ID Numbers:
  • biliary tract injury
First Posted:
Oct 22, 2019
Last Update Posted:
Oct 22, 2019
Last Verified:
Oct 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 22, 2019