- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01189734
Comparison Between Laparoscopic Common Bile Duct Exploration and Intraoperative ERCP for Management of Common Bile Duct Stones
August 26, 2010 updated by: Mansoura University
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
248
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Dakahlia
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Mansoura, Dakahlia, Egypt, 35516
- Gastroenterology Surgical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 90 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- preoperatively diagnosed common bile duct stones
Exclusion Criteria:
- liver cirrhosis pregnancy ASA III, IV Previous abdominal surgery postcholecystectomy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: laparoscopic common bile duct exploration
|
|
Active Comparator: laparoscopic cholecystectomy with intraoperative ES
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
success/failure of common bile duct removal
|
Secondary Outcome Measures
Outcome Measure |
---|
Surgical time
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
August 25, 2010
First Submitted That Met QC Criteria
August 26, 2010
First Posted (Estimate)
August 27, 2010
Study Record Updates
Last Update Posted (Estimate)
August 27, 2010
Last Update Submitted That Met QC Criteria
August 26, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCBDEIOES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Clinical Trials on laparoscopic common bile duct exploration
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