ERCP Plus Laparoscopic Cholecystectomy Versus Laparoscopic Common Bile Duct Exploration and Cholecystectomy
- Conditions
- Common Bile Duct Calculi
- Interventions
- Procedure: Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomyProcedure: aparoscopic common bile duct exploration and laparoscopic cholecystectomy
- Registration Number
- NCT05901363
- Lead Sponsor
- South Valley University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 218
- Patients diagnosed with cholecystocholedocholithiasis
- American Society of Anesthesiologists (ASA) scores of I-III
- Age 20-70 years.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy laparoscopic common bile duct exploration and laparoscopic cholecystectomy aparoscopic common bile duct exploration and laparoscopic cholecystectomy -
- Primary Outcome Measures
Name Time Method success rate 2 years successful laparoscopic cholecystectomy and successful common bile duct stone extraction
- Secondary Outcome Measures
Name Time Method The total cost of treatment 30 days 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
operative time from 1 to 5 hours the overall time of the procedure
morbidity 3 years any intraoperative or postoperative adverse event
the number of hospital readmission 3 years the number of postoperative intervention 3 years
Trial Locations
- Locations (1)
Mohammed Ahmed Omar
🇪🇬Qinā, Qena, Egypt