Comparison Between Pre and Intraoperative ERCP in Treatment of Common Bile Duct Stones

January 11, 2010 updated by: Mansoura University

Preoperative Versus Intraoperative Endoscopic Sphincterotomy for Management of Choledocholithiasis and Cholecystolithiasis

ERCP plays an important role in management of common bile duct stones. Herein the investigators compare preoperative against intraoperative ERCP.

210 were included but only 198 patients were randomly divided into two groups; PES/LC (100 patients) and LC/IOES (98 patients).

The total hospital stay were significantly shorter in the group of LC/IOES

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35516
        • Ahmed Abdel-Raouf El-Geidie

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

12 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with gallstones and common bile duct stones

Exclusion Criteria:

  • contraindications to ercp

contraindication to laparoscopy

biliary pancreatitis

refusal to participate

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: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PES/LC
preoperative ES followed by LC within the same hospital admission
Procedure: preoperative ERCP and LC
preoperative ERCP followed by LC
Active Comparator: LC/IOES
laparoscopic cholecystectomy with intraoperative ercp under the same anesthesia
Procedure: Intraoperative ERCP and LC
LC and intraoperative ERCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clearance of stones from the common bile duct
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
bile duct injuries, retained stones, hospital stay, surgical time, conversion to open cholecystectomy
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

June 1, 2006

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

January 5, 2010

First Submitted That Met QC Criteria

January 11, 2010

First Posted (Estimate)

January 12, 2010

Study Record Updates

Last Update Posted (Estimate)

January 12, 2010

Last Update Submitted That Met QC Criteria

January 11, 2010

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERCP123

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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