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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Fistula

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 10, 2019
    Last Updated
    October 18, 2019
    Sponsor
    Assiut University
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    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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