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Study Investigating the Best Method of Treatment of Bile Duct Stones in Higher Risk Patients

Primary Purpose

Choledocholithiasis, Higher Risk Patients

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy
Laparoscopic bile duct exploration during cholecystectomy
Sponsored by
North Bristol NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choledocholithiasis focused on measuring Common Bile Duct Calculi, Choledocholithiasis, Endoscopic sphincterotomy, Cholecystectomy, laparoscopic, Laparoscopic bile duct exploration

Eligibility Criteria

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

Inclusion Criteria:

  • Gallbladder stones
  • At least strong evidence of bile duct stones (abnormal LFTs and dilated bile duct)
  • Higher risk (>70yrs, >60yrs with co-morbidity, >50 with BMI>40)

Exclusion Criteria:

  • Not fit for general anaesthesia
  • Cholangitis requiring emergency ERCP
  • Previous upper GI surgery making ERCP impossible

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    A

    B

    Arm Description

    Outcomes

    Primary Outcome Measures

    Bile duct clearance

    Secondary Outcome Measures

    Morbidity and mortality
    Post-operative stay
    Procedures per patient
    Conversion to open surgery

    Full Information

    First Posted
    January 29, 2008
    Last Updated
    January 29, 2008
    Sponsor
    North Bristol NHS Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00612846
    Brief Title
    Study Investigating the Best Method of Treatment of Bile Duct Stones in Higher Risk Patients
    Official Title
    A Randomised Clinical Trial to Compare Endoscopic Sphincterotomy and Subsequent Laparoscopic Cholecystectomy With Primary Laparoscopic Bile Duct Exploration During Cholecystectomy in Higher Risk Patients With Choledocholithiasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Terminated
    Why Stopped
    Terminated early due to slow recruitment
    Study Start Date
    March 2000 (undefined)
    Primary Completion Date
    March 2006 (Actual)
    Study Completion Date
    March 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    North Bristol NHS Trust

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of the trial is to compare two operations which are used to treat bile duct stones. The hypothesis of the study is that there is no difference between endoscopic sphincterotomy followed by laparoscopic cholecystectomy or laparoscopic bile duct exploration during laparoscopic cholecystectomy in the treatment of bile duct stones in higher risk patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Choledocholithiasis, Higher Risk Patients
    Keywords
    Common Bile Duct Calculi, Choledocholithiasis, Endoscopic sphincterotomy, Cholecystectomy, laparoscopic, Laparoscopic bile duct exploration

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    91 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Title
    B
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy
    Intervention Description
    Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic bile duct exploration during cholecystectomy
    Intervention Description
    Laparoscopic bile duct exploration during cholecystectomy
    Primary Outcome Measure Information:
    Title
    Bile duct clearance
    Time Frame
    Peri-operative
    Secondary Outcome Measure Information:
    Title
    Morbidity and mortality
    Time Frame
    30 day or directly relating to intervention
    Title
    Post-operative stay
    Time Frame
    Post-operative stay
    Title
    Procedures per patient
    Time Frame
    Interventions required to acheive duct clearance
    Title
    Conversion to open surgery
    Time Frame
    Peri-operative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Gallbladder stones At least strong evidence of bile duct stones (abnormal LFTs and dilated bile duct) Higher risk (>70yrs, >60yrs with co-morbidity, >50 with BMI>40) Exclusion Criteria: Not fit for general anaesthesia Cholangitis requiring emergency ERCP Previous upper GI surgery making ERCP impossible
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael H Thompson, MD, FRCS
    Organizational Affiliation
    North Bristol NHS Trust
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study Investigating the Best Method of Treatment of Bile Duct Stones in Higher Risk Patients

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