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ERCP Plus Laparoscopic Cholecystectomy Versus Laparoscopic Common Bile Duct Exploration and Cholecystectomy

Primary Purpose

Common Bile Duct Calculi

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy
aparoscopic common bile duct exploration and laparoscopic cholecystectomy
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Bile Duct Calculi focused on measuring Endoscopic retrograde cholangiopancreatography, laparoscopic common bile duct exploration, Laparoscopic cholecystectomy, single operator, cholecystocholedocholithiasis

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mohammed Ahmed Omar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy

laparoscopic common bile duct exploration and laparoscopic cholecystectomy

Arm Description

endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy

Outcomes

Primary Outcome Measures

success rate
successful laparoscopic cholecystectomy and successful common bile duct stone extraction

Secondary Outcome Measures

operative time
the overall time of the procedure
morbidity
any intraoperative or postoperative adverse event
mortality
death of patient
Hospital stay
the length of hospital stay from the day of admission to the day of discharge
the number of hospital readmission
the number of postoperative intervention
The total cost of treatment

Full Information

First Posted
June 3, 2023
Last Updated
June 12, 2023
Sponsor
South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT05901363
Brief Title
ERCP Plus Laparoscopic Cholecystectomy Versus Laparoscopic Common Bile Duct Exploration and Cholecystectomy
Official Title
ERCP Plus Laparoscopic Cholecystectomy Versus Laparoscopic Common Bile Duct Exploration and Cholecystectomy for Cholecystocholedocholithiasis - The Same Operator: A Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
October 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Bile Duct Calculi
Keywords
Endoscopic retrograde cholangiopancreatography, laparoscopic common bile duct exploration, Laparoscopic cholecystectomy, single operator, cholecystocholedocholithiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy
Arm Type
Experimental
Arm Description
endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy
Arm Title
laparoscopic common bile duct exploration and laparoscopic cholecystectomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy
Other Intervention Name(s)
ERCP plus LC
Intervention Description
laparoscopic removal of gallbladder and endoscopic extraction of common bile duct stones
Intervention Type
Procedure
Intervention Name(s)
aparoscopic common bile duct exploration and laparoscopic cholecystectomy
Other Intervention Name(s)
LCBDE plus LC
Intervention Description
laparoscopic removal of gallbladder and laparoscopic extraction of common bile duct stones
Primary Outcome Measure Information:
Title
success rate
Description
successful laparoscopic cholecystectomy and successful common bile duct stone extraction
Time Frame
2 years
Secondary Outcome Measure Information:
Title
operative time
Description
the overall time of the procedure
Time Frame
from 1 to 5 hours
Title
morbidity
Description
any intraoperative or postoperative adverse event
Time Frame
3 years
Title
mortality
Description
death of patient
Time Frame
3 years
Title
Hospital stay
Description
the length of hospital stay from the day of admission to the day of discharge
Time Frame
30 days
Title
the number of hospital readmission
Time Frame
3 years
Title
the number of postoperative intervention
Time Frame
3 years
Title
The total cost of treatment
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed A Omar
Organizational Affiliation
General Surgery Department, Faculty of Medicine, South Valley University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mohammed Ahmed Omar
City
Qinā
State/Province
Qena
ZIP/Postal Code
83523
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After publication
IPD Sharing Time Frame
For 1 year
IPD Sharing Access Criteria
After publication

Learn more about this trial

ERCP Plus Laparoscopic Cholecystectomy Versus Laparoscopic Common Bile Duct Exploration and Cholecystectomy

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