Comparison Between Laparoscopic Common Bile Duct Exploration and Intraoperative ERCP for Management of Common Bile Duct Stones

NCT ID: NCT01189734

Last Updated: 2010-08-27

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

COMPLETED

Clinical Phase

NA

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Brief Summary

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Many options are available for management of common bile duct stones. the most recent development in this field is single-session approach by one of two methods; laparoscopic common bile duct exploration and intraoperative endoscopic sphincterotomy. In this study, the investigators prospectively compare these two methods for management of patients with preoperatively diagnosed common bile duct stones to settle the best option.

Detailed Description

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Conditions

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Common Bile Duct Gallstones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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laparoscopic common bile duct exploration

Group Type PLACEBO_COMPARATOR

laparoscopic common bile duct exploration

Intervention Type PROCEDURE

laparoscopic cholecystectomy with intraoperative ES

Group Type ACTIVE_COMPARATOR

laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomy

Intervention Type PROCEDURE

Interventions

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laparoscopic common bile duct exploration

Intervention Type PROCEDURE

laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* preoperatively diagnosed common bile duct stones

Exclusion Criteria

* liver cirrhosis pregnancy ASA III, IV Previous abdominal surgery postcholecystectomy
Minimum Eligible Age

12 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Locations

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Gastroenterology Surgical Center

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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LCBDEIOES

Identifier Type: -

Identifier Source: org_study_id

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