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

Sponsor

South Valley University (Other)

Overall Status

Completed

CT.gov ID

NCT05901363

Collaborator

(none)

218

Enrollment

Location

Arms

44.9

Actual Duration (Months)

4.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Common Bile Duct Calculi	Procedure: Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy Procedure: aparoscopic common bile duct exploration and laparoscopic cholecystectomy	N/A

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

218 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

ERCP Plus Laparoscopic Cholecystectomy Versus Laparoscopic Common Bile Duct Exploration and Cholecystectomy for Cholecystocholedocholithiasis - The Same Operator: A Multicenter Randomized Controlled Trial

Actual Study Start Date :

Feb 1, 2019

Actual Primary Completion Date :

Oct 30, 2021

Actual Study Completion Date :

Oct 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy	Procedure: Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy laparoscopic removal of gallbladder and endoscopic extraction of common bile duct stones Other Names: ERCP plus LC
Active Comparator: laparoscopic common bile duct exploration and laparoscopic cholecystectomy	Procedure: aparoscopic common bile duct exploration and laparoscopic cholecystectomy laparoscopic removal of gallbladder and laparoscopic extraction of common bile duct stones Other Names: LCBDE plus LC

Arm

Intervention/Treatment

Experimental: Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy

endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy

Procedure: Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy

laparoscopic removal of gallbladder and endoscopic extraction of common bile duct stones

Other Names:

ERCP plus LC

Active Comparator: laparoscopic common bile duct exploration and laparoscopic cholecystectomy

Procedure: aparoscopic common bile duct exploration and laparoscopic cholecystectomy

laparoscopic removal of gallbladder and laparoscopic extraction of common bile duct stones

Other Names:

LCBDE plus LC

Outcome Measures

Primary Outcome Measures

success rate [2 years]
successful laparoscopic cholecystectomy and successful common bile duct stone extraction

Secondary Outcome Measures

operative time [from 1 to 5 hours]
the overall time of the procedure
morbidity [3 years]
any intraoperative or postoperative adverse event
mortality [3 years]
death of patient
Hospital stay [30 days]
the length of hospital stay from the day of admission to the day of discharge
the number of hospital readmission [3 years]
the number of postoperative intervention [3 years]
The total cost of treatment [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.