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

Common Bile Duct Calculi Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05901363
• Other study ID #: SVU/MED/SUR011/4/23/4/613
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: October 30, 2022

Study information

• Verified date: June 2023
• Source: South Valley University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Calculi
• Common Bile Duct Calculi
• Gallstones

Intervention

Procedure:
• Endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy
laparoscopic removal of gallbladder and endoscopic extraction of common bile duct stones
• aparoscopic common bile duct exploration and laparoscopic cholecystectomy
laparoscopic removal of gallbladder and laparoscopic extraction of common bile duct stones

Locations

Country	Name	City	State
Egypt	Mohammed Ahmed Omar	Qina	Qena

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success rate	successful laparoscopic cholecystectomy and successful common bile duct stone extraction	2 years
Secondary	operative time	the overall time of the procedure	from 1 to 5 hours
Secondary	morbidity	any intraoperative or postoperative adverse event	3 years
Secondary	mortality	death of patient	3 years
Secondary	Hospital stay	the length of hospital stay from the day of admission to the day of discharge	30 days
Secondary	the number of hospital readmission		3 years
Secondary	the number of postoperative intervention		3 years
Secondary	The total cost of treatment		30 days