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

Mansoura University

Status: Completed

Conditions: Common Bile Duct Gallstones

Treatments: Procedure: laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomy; Procedure: laparoscopic common bile duct exploration

Study type: Interventional

Funder types: Other

Identifiers

NCT01189734

LCBDEIOES

Details and patient eligibility

About

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.

Enrollment: 248 patients

Sex: All

Ages: 12 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• preoperatively diagnosed common bile duct stones

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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248 participants in 2 patient groups, including a placebo group

laparoscopic common bile duct exploration

Placebo Comparator group

Treatment:

Procedure: laparoscopic common bile duct exploration

laparoscopic cholecystectomy with intraoperative ES

Active Comparator group

Treatment:

Procedure: laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomy