Clinical trial NCT05901363: 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
Overall status: COMPLETED
Phase: NA
Conditions: Common Bile Duct Calculi
Keywords: Endoscopic retrograde cholangiopancreatography
laparoscopic common bile duct exploration
Laparoscopic cholecystectomy
single operator
cholecystocholedocholithiasis
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 218
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: success rate
timeFrame: 2 years
Secondary outcomes:
measure: operative time
timeFrame: from 1 to 5 hours
measure: morbidity
timeFrame: 3 years
measure: mortality
timeFrame: 3 years
measure: Hospital stay
timeFrame: 30 days
measure: the number of hospital readmission
timeFrame: 3 years
measure: the number of postoperative intervention
timeFrame: 3 years
measure: The total cost of treatment
timeFrame: 30 days
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: Mohammed Ahmed Omar
state: Qena
Study officials:
affiliation: General Surgery Department, Faculty of Medicine, South Valley University
name: Mohammed A Omar
role: PRINCIPAL_INVESTIGATOR
References: