Early Versus Late Intervention After Biliary Tract Injury Post Cholecystectomy
Primary Purpose
Biliary Fistula
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CBD exoloration
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Fistula
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
group with biliary injury
Arm Description
group for Early versus late intervention after biliary tract injury post cholecystectomy
Outcomes
Primary Outcome Measures
faliure of interventon
By mesurment liver functon as direct billirubin
Secondary Outcome Measures
plan for improving
by mesurment of liver function as AST
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04134546
Brief Title
Early Versus Late Intervention After Biliary Tract Injury Post Cholecystectomy
Official Title
Early Versus Late Intervention After Biliary Tract Injury Post Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2019 (Anticipated)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
October 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Fistula
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group with biliary injury
Arm Type
Experimental
Arm Description
group for Early versus late intervention after biliary tract injury post cholecystectomy
Intervention Type
Procedure
Intervention Name(s)
CBD exoloration
Intervention Description
Early versus late intervention after biliary tract injury post cholecystectomy
Primary Outcome Measure Information:
Title
faliure of interventon
Description
By mesurment liver functon as direct billirubin
Time Frame
two months
Secondary Outcome Measure Information:
Title
plan for improving
Description
by mesurment of liver function as AST
Time Frame
two months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Early Versus Late Intervention After Biliary Tract Injury Post Cholecystectomy
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