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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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Gallstones
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01190332

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

No publications provided

Responsible Party: ahmed abdel-raouf el-geidie, gastroenterology surgical center
ClinicalTrials.gov Identifier: NCT01190332     History of Changes
Other Study ID Numbers: 7918
Study First Received: July 6, 2010
Last Updated: August 26, 2010
Health Authority: Egypt: Faculty of medicine Mansoura univerity

Keywords provided by Mansoura University:
common bile duct stones

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

ClinicalTrials.gov processed this record on June 17, 2013