Common Bile Duct Calculi
Conditions
Keywords
Endoscopic retrograde cholangiopancreatography, laparoscopic common bile duct exploration, Laparoscopic cholecystectomy, single operator, cholecystocholedocholithiasis
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.
Interventions
PROCEDUREEndoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy
laparoscopic removal of gallbladder and endoscopic extraction of common bile duct stones
PROCEDUREaparoscopic common bile duct exploration and laparoscopic cholecystectomy
laparoscopic removal of gallbladder and laparoscopic extraction of common bile duct stones
Sponsors
South Valley University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| success rate | 2 years | successful laparoscopic cholecystectomy and successful common bile duct stone extraction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| operative time | from 1 to 5 hours | the overall time of the procedure |
| the number of postoperative intervention | 3 years | — |
| The total cost of treatment | 30 days | — |
| the number of hospital readmission | 3 years | — |
Countries
Egypt
Outcome results
None listed