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

January 29, 2008 updated by: North Bristol NHS Trust

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Procedure: Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy
Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy
Experimental: B
Procedure: Laparoscopic bile duct exploration during cholecystectomy
Laparoscopic bile duct exploration during cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bile duct clearance
Time Frame: Peri-operative
Peri-operative

Secondary Outcome Measures

Outcome Measure
Time Frame
Morbidity and mortality
Time Frame: 30 day or directly relating to intervention
30 day or directly relating to intervention
Post-operative stay
Time Frame: Post-operative stay
Post-operative stay
Procedures per patient
Time Frame: Interventions required to acheive duct clearance
Interventions required to acheive duct clearance
Conversion to open surgery
Time Frame: Peri-operative
Peri-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Bristol NHS Trust

Investigators

  • Study Director: Michael H Thompson, MD, FRCS, North Bristol NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

January 29, 2008

First Submitted That Met QC Criteria

January 29, 2008

First Posted (Estimate)

February 12, 2008

Study Record Updates

Last Update Posted (Estimate)

February 12, 2008

Last Update Submitted That Met QC Criteria

January 29, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112/99

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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