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

NCT06599437 | Completed DMC

• 1 other identifier: HD000192
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Choledocholithiasis with Cholecystitis

Keywords

choledocholithiasis; ERCP; Early cholecystectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• operative time

  during surgery

• pancreatitis

  3 months after surgery

• conversion to open surgery

  During surgery

• Bleeding

  during surger and up to 3 weeks

• the presence of intraoperative adhesions

  During surgery

Study Arms (2)

Early same admission laparoscopic cholecystectomy ( group A)

ACTIVE COMPARATOR

Early laparoscopic cholecystectomy is performed on next day within 24 hours after common bile duct stone removal by ERCP.

Procedure: laparoscopic cholecystectomy

Late laparoscopic cholecystectomy ( group B)

ACTIVE COMPARATOR

Late laparoscopic cholecystectomy is performed 6 weeks after common bile duct stones clearance

Procedure: Late laparoscopic cholecystectomy

Interventions

laparoscopic cholecystectomy PROCEDURE

Early laparoscopic cholecystectomy in the same admission after atone clearance from the bile ducts via ERCP.

Early same admission laparoscopic cholecystectomy ( group A)

Late laparoscopic cholecystectomy PROCEDURE

Laparoscopic cholecystectomy is performed 6 weeks after clearance of stones from the common bile duct.

Late laparoscopic cholecystectomy ( group B)

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Damanhour Medical National Institute: lead

Study Sites (1)

Damanhur Medical National Institute

Damanhur, Behira, 22951, Egypt

Location

MeSH Terms

Conditions

Choledocholithiasis

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Hepatopacreatobiliary and GI Surgery

Study Record Dates

• First Submitted: September 7, 2024
• First Posted: September 19, 2024
• Study Start: December 1, 2021
• Primary Completion: April 1, 2024
• Study Completion: August 15, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

EG (1)