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

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.

Study Overview

• Status: Completed
• Conditions: Common Bile Duct Calculi
• Intervention / Treatment: Procedure: Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy; Procedure: aparoscopic common bile duct exploration and laparoscopic cholecystectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Qena
    • Qinā, Qena, Egypt, 83523
      • Mohammed Ahmed Omar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: South Valley University
• Investigators: Principal Investigator: Mohammed A Omar, General Surgery Department, Faculty of Medicine, South Valley University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: June 3, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Estimated): June 13, 2023

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Laparoscopic cholecystectomy; Endoscopic retrograde cholangiopancreatography; laparoscopic common bile duct exploration; single operator; cholecystocholedocholithiasis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Cholelithiasis; Cholecystolithiasis; Calculi; Gallstones
• Other Study ID Numbers: SVU/MED/SUR011/4/23/4/613

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After publication
• IPD Sharing Time Frame: For 1 year
• IPD Sharing Access Criteria: After publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No