For Patients with Stones in Gallbladder and Bile Duct Stones At the Same Time, Surgical Removal of the Gallbladder with the Laparoscope is Done in the Same Admission Compared to Its Removal After 6 Weeks Following Successful Removel of the Stones from the Bile Ducts by the Side View Endoscope

Index Laparoscopic Cholecystectomy Following Clearance of Common Bile Duct Stones Via Endoscopic Retrograde Cholangiography

The goal of this clinical trial is to learn if early laparoscopic cholecystectomy is safe and feasible when performed during the same admission for patients with concomitant gallbladder and common bile duct stones after clearance of CBD stones via ERCP in comparison to Late laparoscopic cholecystectomy 6 weeks after ERCP. The main questions it aims to answer are: laparoscopic cholecystectomy

• Does index laparoscopic cholecystectomy associate with less recurrence of biliary complications?
• Is index laparoscopic cholecystectomy feasible and safe for the patients in terms of intraoperative difficulties, conversion to open, hospital stay, and postoperative complications than late laparoscopic cholecystectomy? the investigator will compare index laparoscopic cholecystectomy with late laparoscopic cholecystectomy 6 weeks after ERCP to see if index laparoscopic cholecystectomy is safe and feasible and associated with better outcomes.

Participants will:

Come to the outpatient clinic every week after intervention for follow-up for 3 months after surgery.

Study Overview

• Status: Completed
• Conditions: Choledocholithiasis with Cholecystitis
• Intervention / Treatment: Procedure: laparoscopic cholecystectomy; Procedure: Late laparoscopic cholecystectomy

Detailed Description

The study population of this randomized controlled trial study is those who underwent CBD stone clearance by ERCP. The included fifty patients were stratified randomly into two groups: early and delayed.

Randomization was done using computer-generated random number sequences in concealed envelopes with a block randomization design. Laparoscopic cholecystectomy is performed on the next day after successful clearance of stones from CBD while, the patient is still admitted, for the early group and postponed 4 to 6 weeks for the delayed group after the patient is discharged home.

Laparoscopic cholecystectomy was performed by the same surgical team for both groups.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Behira
    • Damanhur, Behira, Egypt, 22951
      • Damanhur Medical National Institute

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients with concomitant gallbladder and common bile duct stone who underwent clearance of common bile duct stones by ERCP

Exclusion Criteria: patients with any of the following:

• Severe pancreatitis
• Suspicion of post-ERCP bleeding or perforation,
• Associated malignancy
• Those in whom ERCP failed to clear the CBD stones

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Early same admission laparoscopic cholecystectomy ( group A); Early laparoscopic cholecystectomy is performed on next day within 24 hours after common bile duct stone removal by ERCP.	Procedure: laparoscopic cholecystectomy; Early laparoscopic cholecystectomy in the same admission after atone clearance from the bile ducts via ERCP.
Active Comparator: Late laparoscopic cholecystectomy ( group B); Late laparoscopic cholecystectomy is performed 6 weeks after common bile duct stones clearance	Procedure: Late laparoscopic cholecystectomy; Laparoscopic cholecystectomy is performed 6 weeks after clearance of stones from the common bile duct.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrence of biliary events	the occurence of acute cholecystitism biliary colics, common bile duct stonem pancreatitisand cholangitis after ERCP while waiting for laparoscopic cholecystectomy	up to 3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time	time from the first incision of skin to skin closure and completion of surgery	during surgery
pancreatitis	acute inflammation of the pancreas : abdominal pain, elevated lipase and amylase ( more than 3 folds) and/or findings specific for the pancreatitits on imaging.	3 months after surgery
conversion to open surgery	termination of the laparoscopic procedure and perfome the surgery by the conventional open surgery	During surgery
Bleeding	Intraoperative or postoperative bleeding that requires blood transfusion	during surger and up to 3 weeks
the presence of intraoperative adhesions	Adhesions around the gallbladder and at the Calot's triangle	During surgery
Bile leak	the leak of bile through the drain or intraabdominally	up to 1 week after surgery
Wound infection	Any evidence of infection in the wounds : redness, pain or discharge of infected fluids from the wounds	up to 3 months after surgery
hospital stays	the sum the length of stay after ERCP and laparoscopic cholecystectomy including readmission for complication management	from admission to the end of post operative follow up at 3 months after surgery
post oprative pain	the degree pain described by the patients after surgery on the visual rating scale	after surgery and up to 3 days

Collaborators and Investigators

• Sponsor: Damanhour Medical National Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): August 15, 2024

Study Registration Dates

• First Submitted: September 7, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: ERCP; choledocholithiasis; Early cholecystectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Bile Duct Diseases; Common Bile Duct Diseases; Cholelithiasis; Cholecystitis; Choledocholithiasis
• Other Study ID Numbers: HD000192

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No