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Conventional Versus Rendezvous Technique of Intraoperative Endoscopic Retrograde Cholangiopancreatography

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01190332
First Posted: August 27, 2010
Last Update Posted: August 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mansoura University
  Purpose
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.

Condition Intervention
Common Bile Duct Gallstones Procedure: endoscopic sphincterotomy by conventional method Procedure: endoscopic sphincterotomy by rendezvous method

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • success/failure rate of common bile duct stones removal

Secondary Outcome Measures:
  • complication rate

Enrollment: 98
Study Start Date: October 2007
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: conventional technique of ERCP Procedure: endoscopic sphincterotomy by conventional method
Active Comparator: Rendezvous technique Procedure: endoscopic sphincterotomy by rendezvous method

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190332


Locations
Egypt
Gastroenterology Surgical Center
Mansoura, Dakahlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University
  More Information

Responsible Party: ahmed abdel-raouf el-geidie, gastroenterology surgical center
ClinicalTrials.gov Identifier: NCT01190332     History of Changes
Other Study ID Numbers: 7918
First Submitted: July 6, 2010
First Posted: August 27, 2010
Last Update Posted: August 27, 2010
Last Verified: February 2010

Keywords provided by Mansoura University:
common bile duct stones

Additional relevant MeSH terms:
Gallstones
Cholelithiasis
Biliary Tract Diseases
Digestive System Diseases
Cholecystolithiasis
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical