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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01190332
Other study ID # 7918
Secondary ID
Status Completed
Phase N/A
First received July 6, 2010
Last updated August 26, 2010
Start date October 2007
Est. completion date March 2010

Study information

Verified date February 2010
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority Egypt: Faculty of medicine Mansoura univerity
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date March 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

Procedure:
endoscopic sphincterotomy by conventional method

endoscopic sphincterotomy by rendezvous method


Locations

Country Name City State
Egypt Gastroenterology Surgical Center Mansoura Dakahlia

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary success/failure rate of common bile duct stones removal
Secondary complication rate
See also
  Status Clinical Trial Phase
Completed NCT02329977 - Rate of Duodenal-biliary Reflux Increases in Patients With Recurrent Common Bile Duct Stones N/A
Recruiting NCT02703077 - Endoscopic Treatment of Difficult Bile Duct Stones: Spyglass + EHL x Balloon Dilation of the Papilla Phase 4
Recruiting NCT01425177 - Effect of Saline Irrigation to DEcrease Rate Of Residual Common Bile Duct Stones Phase 3
Completed NCT01189734 - Comparison Between Laparoscopic Common Bile Duct Exploration and Intraoperative ERCP for Management of Common Bile Duct Stones N/A