Back to resultsComparison Between Pre and Intraoperative ERCP in Treatment of Common Bile Duct Stones
Primary Purpose
Common Bile Duct Stones.
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
preoperative ERCP and LC
Intraoperative ERCP and LC
Sponsored by
About this trial
This is an interventional treatment trial for Common Bile Duct Stones. focused on measuring Choledocholithias, Common bile duct stones, Endoscopic retrograde cholangiopancreatography, endoscopic sphincterotomy, Preoperative, intraoperative, Laparoscopic common bile duct exploration
Eligibility Criteria
Inclusion Criteria:
- patients with gallstones and common bile duct stones
Exclusion Criteria:
- contraindications to ercp
contraindication to laparoscopy
biliary pancreatitis
refusal to participate
Sites / Locations
- Ahmed Abdel-Raouf El-Geidie
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PES/LC
LC/IOES
Arm Description
preoperative ES followed by LC within the same hospital admission
laparoscopic cholecystectomy with intraoperative ercp under the same anesthesia
Outcomes
Primary Outcome Measures
clearance of stones from the common bile duct
Secondary Outcome Measures
bile duct injuries, retained stones, hospital stay, surgical time, conversion to open cholecystectomy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01046552
Brief Title
Comparison Between Pre and Intraoperative ERCP in Treatment of Common Bile Duct Stones
Official Title
Preoperative Versus Intraoperative Endoscopic Sphincterotomy for Management of Choledocholithiasis and Cholecystolithiasis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
ERCP plays an important role in management of common bile duct stones. Herein the investigators compare preoperative against intraoperative ERCP.
210 were included but only 198 patients were randomly divided into two groups; PES/LC (100 patients) and LC/IOES (98 patients).
The total hospital stay were significantly shorter in the group of LC/IOES
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Bile Duct Stones.
Keywords
Choledocholithias, Common bile duct stones, Endoscopic retrograde cholangiopancreatography, endoscopic sphincterotomy, Preoperative, intraoperative, Laparoscopic common bile duct exploration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PES/LC
Arm Type
Active Comparator
Arm Description
preoperative ES followed by LC within the same hospital admission
Arm Title
LC/IOES
Arm Type
Active Comparator
Arm Description
laparoscopic cholecystectomy with intraoperative ercp under the same anesthesia
Intervention Type
Procedure
Intervention Name(s)
preoperative ERCP and LC
Intervention Description
preoperative ERCP followed by LC
Intervention Type
Procedure
Intervention Name(s)
Intraoperative ERCP and LC
Intervention Description
LC and intraoperative ERCP
Primary Outcome Measure Information:
Title
clearance of stones from the common bile duct
Time Frame
6 months
Secondary Outcome Measure Information:
Title
bile duct injuries, retained stones, hospital stay, surgical time, conversion to open cholecystectomy
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with gallstones and common bile duct stones
Exclusion Criteria:
contraindications to ercp
contraindication to laparoscopy
biliary pancreatitis
refusal to participate
Facility Information:
Facility Name
Ahmed Abdel-Raouf El-Geidie
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Links:
URL
http://www.mans.edu.eg
Description
mansoura university
Learn more about this trial
Comparison Between Pre and Intraoperative ERCP in Treatment of Common Bile Duct Stones
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