ERCP Plus Laparoscopic Cholecystectomy Versus Laparoscopic Common Bile Duct Exploration and Cholecystectomy
June 12, 2023 updated by: Mohammed Ahmed Omar, MD, South Valley University
ERCP Plus Laparoscopic Cholecystectomy Versus Laparoscopic Common Bile Duct Exploration and Cholecystectomy for Cholecystocholedocholithiasis - The Same Operator: A Multicenter Randomized Controlled Trial
Around 10-18% of patients undergoing cholecystectomy for gallstones have common bile duct (CBD) stones.
Currently, various procedures for the treatment of cholecystocholedocholithiasis are available including open cholecystectomy plus open common bile duct exploration (OC+OCBDE), laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC+LCBDE), may be trans-cystic or trans-choledochal, and laparoscopic cholecystectomy plus endoscopic retrograde cholangiopancreatography (LC+ERCP), which may be performed pre, at, or after LC.
Study Overview
Status
Completed
Conditions
Detailed Description
Around 10-18% of patients undergoing cholecystectomy for gallstones have common bile duct (CBD) stones. Currently, various procedures for the treatment of cholecystocholedocholithiasis are available including open cholecystectomy plus open common bile duct exploration (OC+OCBDE), laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC+LCBDE), may be trans-cystic or trans-choledochal, and laparoscopic cholecystectomy plus endoscopic retrograde cholangiopancreatography (LC+ERCP), which may be performed pre, at, or after LC.
Single-session treatment of gallbladder and CBD stones is safe, efficient, shortens hospital stay, and is less expensive than staged procedures.
Although there is some evidence suggesting that LCBDE may be associated with a lower rate of retained stones compared with ERCP, previous studies comparing LCBDE with ERCP and stone extraction have collectively failed to demonstrate the superiority of one approach over the other.
Study Type
Interventional
Enrollment (Actual)
218
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
-
-
Qena
-
Qinā, Qena, Egypt, 83523
- Mohammed Ahmed Omar
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients diagnosed with cholecystocholedocholithiasis
- American Society of Anesthesiologists (ASA) scores of I-III
- Age 20-70 years.
Exclusion Criteria:
- cholangitis,
- acute biliary pancreatitis,
- suspected Mirizzi syndrome,
- suspected hepatobiliary malignancy,
- perforated gallbladder,
- biliary peritonitis,
- intrahepatic stones,
- pregnancy,
- previous cholecystectomy,
- altered anatomy such as Billroth II reconstruction or any form of Roux-en-Y reconstruction that interfere with the endoscopic approach,
- Contraindications to laparoscopic surgery as severe liver cirrhosis or upper abdominal surgery were excluded.
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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy
endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy
|
laparoscopic removal of gallbladder and endoscopic extraction of common bile duct stones
Other Names:
|
|
Active Comparator: laparoscopic common bile duct exploration and laparoscopic cholecystectomy
|
laparoscopic removal of gallbladder and laparoscopic extraction of common bile duct stones
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
success rate
Time Frame: 2 years
|
successful laparoscopic cholecystectomy and successful common bile duct stone extraction
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
operative time
Time Frame: from 1 to 5 hours
|
the overall time of the procedure
|
from 1 to 5 hours
|
|
morbidity
Time Frame: 3 years
|
any intraoperative or postoperative adverse event
|
3 years
|
|
mortality
Time Frame: 3 years
|
death of patient
|
3 years
|
|
Hospital stay
Time Frame: 30 days
|
the length of hospital stay from the day of admission to the day of discharge
|
30 days
|
|
the number of hospital readmission
Time Frame: 3 years
|
3 years
|
|
|
the number of postoperative intervention
Time Frame: 3 years
|
3 years
|
|
|
The total cost of treatment
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohammed A Omar, General Surgery Department, Faculty of Medicine, South Valley University
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 Major Dates
Study Start (Actual)
February 1, 2019
Primary Completion (Actual)
October 30, 2021
Study Completion (Actual)
October 30, 2022
Study Registration Dates
First Submitted
June 3, 2023
First Submitted That Met QC Criteria
June 12, 2023
First Posted (Estimated)
June 13, 2023
Study Record Updates
Last Update Posted (Estimated)
June 13, 2023
Last Update Submitted That Met QC Criteria
June 12, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SVU/MED/SUR011/4/23/4/613
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
After publication
IPD Sharing Time Frame
For 1 year
IPD Sharing Access Criteria
After publication
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.