Conventional Versus Rendezvous Technique of Intraoperative Endoscopic Retrograde Cholangiopancreatography

August 26, 2010 updated by: Mansoura University
One of the new methods for management of common bile duct stones is intraoperative endoscopic sphincterotomy. It can be performed by many techniques. In the study the investigators compare two methods to find out the best technique for intraoperative endoscopic sphincterotomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

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
        • Gastroenterology Surgical Center

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with MRCP evidence of common bile duct stones

Exclusion Criteria:

  • cholangitis pancreatitis ASA GRADE III, IV Unfit for laparoscopy unfit for ERCP

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: conventional technique of ERCP
Procedure: endoscopic sphincterotomy by conventional method
Active Comparator: Rendezvous technique
Procedure: endoscopic sphincterotomy by rendezvous method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
success/failure rate of common bile duct stones removal

Secondary Outcome Measures

Outcome Measure
complication rate

Collaborators and Investigators

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

Sponsor

Mansoura University

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

October 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

July 6, 2010

First Submitted That Met QC Criteria

August 26, 2010

First Posted (Estimate)

August 27, 2010

Study Record Updates

Last Update Posted (Estimate)

August 27, 2010

Last Update Submitted That Met QC Criteria

August 26, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7918 (CTEP)

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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