NCT05901363

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: South Valley University · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Common Bile Duct Calculi

Interventions

Type	Name	Description
PROCEDURE	Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy	laparoscopic removal of gallbladder and endoscopic extraction of common bile duct stones
PROCEDURE	aparoscopic common bile duct exploration and laparoscopic cholecystectomy	laparoscopic removal of gallbladder and laparoscopic extraction of common bile duct stones

Timeline

• Start date: 2019-02-01
• Primary completion: 2021-10-30
• Completion: 2022-10-30
• First posted: 2023-06-13
• Last updated: 2023-06-13

Locations

1 site across 1 country: Egypt