Conventional Versus Rendezvous Technique of Intraoperative Endoscopic Retrograde Cholangiopancreatography

This study has been completed.

Sponsor:

Information provided by:

Mansoura University

ClinicalTrials.gov Identifier:

NCT01190332

First received: July 6, 2010

Last updated: August 26, 2010

Last verified: February 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	July 6, 2010
Last Updated Date	August 26, 2010
Start Date ^ICMJE	October 2007
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 26, 2010)	success/failure rate of common bile duct stones removal
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01190332 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 26, 2010)	complication rate
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Conventional Versus Rendezvous Technique of Intraoperative Endoscopic Retrograde Cholangiopancreatography
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject)
Condition ^ICMJE	Common Bile Duct Gallstones
Intervention ^ICMJE	Procedure: endoscopic sphincterotomy by conventional method Procedure: endoscopic sphincterotomy by rendezvous method
Study Arm (s)	Placebo Comparator: conventional technique of ERCP Intervention: Procedure: endoscopic sphincterotomy by conventional method Active Comparator: Rendezvous technique Intervention: Procedure: endoscopic sphincterotomy by rendezvous method
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	98
Completion Date	March 2010
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Egypt

Administrative Information
NCT Number ^ICMJE	NCT01190332
Other Study ID Numbers ^ICMJE	7918
Has Data Monitoring Committee	Not Provided
Responsible Party	ahmed abdel-raouf el-geidie, gastroenterology surgical center
Study Sponsor ^ICMJE	Mansoura University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Mansoura University
Verification Date	February 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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