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NCT01189734 Clinical Trial

Comparison Between Laparoscopic Common Bile Duct Exploration and Intraoperative ERCP for Management of Common Bile Duct Stones

Common Bile Duct Gallstones Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01189734
Other study ID # LCBDEIOES
Secondary ID
Status Completed
Phase N/A
First received August 25, 2010
Last updated August 26, 2010

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

Clinical Trial Summary

Many options are available for management of common bile duct stones. the most recent development in this field is single-session approach by one of two methods; laparoscopic common bile duct exploration and intraoperative endoscopic sphincterotomy. In this study, the investigators prospectively compare these two methods for management of patients with preoperatively diagnosed common bile duct stones to settle the best option.

Recruitment information / eligibility
Status Completed
Enrollment 248
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 12 Years to 90 Years
Eligibility Inclusion Criteria:

- preoperatively diagnosed common bile duct stones

Exclusion Criteria:

- liver cirrhosis pregnancy ASA III, IV Previous abdominal surgery postcholecystectomy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• laparoscopic common bile duct exploration

• laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomy

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 of common bile duct removal No
Secondary Surgical time No
See also
  Status Clinical Trial Phase
Completed NCT01190332 - Conventional Versus Rendezvous Technique of Intraoperative Endoscopic Retrograde Cholangiopancreatography N/A
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