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

South Valley University

Status: Completed

Conditions: Common Bile Duct Calculi

Treatments: Procedure: Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy; Procedure: aparoscopic common bile duct exploration and laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05901363

SVU/MED/SUR011/4/23/4/613

Details and patient eligibility

About

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.

Full 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.

Enrollment: 218 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients diagnosed with cholecystocholedocholithiasis
2. American Society of Anesthesiologists (ASA) scores of I-III
3. Age 20-70 years.

Exclusion criteria

1. cholangitis,
2. acute biliary pancreatitis,
3. suspected Mirizzi syndrome,
4. suspected hepatobiliary malignancy,
5. perforated gallbladder,
6. biliary peritonitis,
7. intrahepatic stones,
8. pregnancy,
9. previous cholecystectomy,
10. altered anatomy such as Billroth II reconstruction or any form of Roux-en-Y reconstruction that interfere with the endoscopic approach,
11. Contraindications to laparoscopic surgery as severe liver cirrhosis or upper abdominal surgery were excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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218 participants in 2 patient groups

Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy

Experimental group

Description:

endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy

Treatment:

Procedure: Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy

laparoscopic common bile duct exploration and laparoscopic cholecystectomy

Active Comparator group

Treatment:

Procedure: aparoscopic common bile duct exploration and laparoscopic cholecystectomy