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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Common Bile Duct Calculi

Intervention / Treatment
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* Procedure: Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy
* Procedure: aparoscopic common bile duct exploration and laparoscopic cholecystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with cholecystocholedocholithiasis American Society of Anesthesiologists (ASA) scores of I-III Age 20-70 years. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy<br>endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy | Procedure: Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy<br>* laparoscopic removal of gallbladder and endoscopic extraction of common bile duct stones<br>* Other names: ERCP plus LC;|
| Active Comparator: laparoscopic common bile duct exploration and laparoscopic cholecystectomy<br> | Procedure: aparoscopic common bile duct exploration and laparoscopic cholecystectomy<br>* laparoscopic removal of gallbladder and laparoscopic extraction of common bile duct stones<br>* Other names: LCBDE plus LC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate | successful laparoscopic cholecystectomy and successful common bile duct stone extraction | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time | the overall time of the procedure | from 1 to 5 hours | 
| morbidity | any intraoperative or postoperative adverse event | 3 years | 
| mortality | death of patient | 3 years | 
| Hospital stay | the length of hospital stay from the day of admission to the day of discharge | 30 days | 
| the number of hospital readmission |  | 3 years | 
| the number of postoperative intervention |  | 3 years | 
| The total cost of treatment |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic retrograde cholangiopancreatography, laparoscopic common bile duct exploration, Laparoscopic cholecystectomy, single operator, cholecystocholedocholithiasis