Back to resultsComparison Between Laparoscopic Common Bile Duct Exploration and Intraoperative ERCP for Management of Common Bile Duct Stones
Primary Purpose
Common Bile Duct Gallstones
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laparoscopic common bile duct exploration
laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomy
Sponsored by
About this trial
This is an interventional treatment trial for Common Bile Duct Gallstones focused on measuring common bile duct stones, laparoscopic common bile duct exploration, intraoperative ercp, Preoperatively diagnosed common bile duct stones
Eligibility Criteria
Inclusion Criteria:
- preoperatively diagnosed common bile duct stones
Exclusion Criteria:
- liver cirrhosis pregnancy ASA III, IV Previous abdominal surgery postcholecystectomy
Sites / Locations
- Gastroenterology Surgical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
laparoscopic common bile duct exploration
laparoscopic cholecystectomy with intraoperative ES
Arm Description
Outcomes
Primary Outcome Measures
success/failure of common bile duct removal
Secondary Outcome Measures
Surgical time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01189734
Brief Title
Comparison Between Laparoscopic Common Bile Duct Exploration and Intraoperative ERCP for Management of Common Bile Duct Stones
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Mansoura University
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Bile Duct Gallstones
Keywords
common bile duct stones, laparoscopic common bile duct exploration, intraoperative ercp, Preoperatively diagnosed common bile duct stones
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
248 (Actual)
8. Arms, Groups, and Interventions
Arm Title
laparoscopic common bile duct exploration
Arm Type
Placebo Comparator
Arm Title
laparoscopic cholecystectomy with intraoperative ES
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
laparoscopic common bile duct exploration
Intervention Type
Procedure
Intervention Name(s)
laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomy
Primary Outcome Measure Information:
Title
success/failure of common bile duct removal
Secondary Outcome Measure Information:
Title
Surgical time
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
90 Years
Eligibility Criteria
Inclusion Criteria:
preoperatively diagnosed common bile duct stones
Exclusion Criteria:
liver cirrhosis pregnancy ASA III, IV Previous abdominal surgery postcholecystectomy
Facility Information:
Facility Name
Gastroenterology Surgical Center
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Comparison Between Laparoscopic Common Bile Duct Exploration and Intraoperative ERCP for Management of Common Bile Duct Stones
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