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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-03-31

Study Completion Date

2006-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Choledocholithiasis Higher Risk Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy

Intervention Type PROCEDURE

Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy

B

Group Type EXPERIMENTAL

Laparoscopic bile duct exploration during cholecystectomy

Intervention Type PROCEDURE

Laparoscopic bile duct exploration during cholecystectomy

Interventions

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Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy

Intervention Type PROCEDURE

Laparoscopic bile duct exploration during cholecystectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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)