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Conventional Versus Rendezvous Technique of Intraoperative Endoscopic Retrograde Cholangiopancreatography

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ClinicalTrials.gov Identifier: NCT01190332
Recruitment Status : Completed
First Posted : August 27, 2010
Last Update Posted : August 27, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Common Bile Duct Gallstones Procedure: endoscopic sphincterotomy by conventional method Procedure: endoscopic sphincterotomy by rendezvous method

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Study Start Date : October 2007
Primary Completion Date : February 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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

Secondary Outcome Measures :
  1. complication rate

Eligibility Criteria

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 Posted: August 27, 2010    Key Record Dates
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