Early vs Late Laparoscopic Cholecystectomy After Common Bile Duct Stones Clearance Through Ercp.

NCT07130864 | Recruiting DMC

• 1 other identifier: 530/DME/KMC
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

There is controversy about timing of cholecystectomy after the common bile duct is cleared of stones. our study aims to compare the results of early vs late cholecystectomy.

Conditions

Laparoscopic Cholecystectomy; Choledocholithiasis; ERCP; Bile Duct Injury

Outcome Measures

Primary Outcomes (1)

• Difficulty level of cholecystectomy

  the presence of diffuse pericholecystic scar adhesions, Calot's triangle with intense fibrosis, atrophic gallbladder, presence of a cholecysto-enteric or cholecyto-choledochal fistula, presence of necrotic changes, liver abscess or the presence of impacted stones and the help of a senior colleague will be considered a difficult cholecystectomy

  From start of surgery till end, On day 1 of surgery

Secondary Outcomes (2)

• Bile duct injury

  From the day 1 of surgery till one month

• Hospital stay

  from day 1 of surgery till discharge, upto 1 month

Study Arms (2)

Early Group

EXPERIMENTAL

Early group consist of those patients whose cholecystectomy is performed within 72 hours of ERCP .

Procedure: Early cholecystectomy

Late group

EXPERIMENTAL

Late group consist of those patients whose cholecystectomy is performed after 72 hours of ERCP.

Procedure: Late cholecystectomy

Interventions

Early cholecystectomy PROCEDURE

Early cholecystectomy is performed within 72 hours of ERCP.

Early Group

Late cholecystectomy PROCEDURE

Late cholecystectomy is performed after 72 hours of ERCP

Late group

Eligibility Criteria

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

You may qualify if:

• All patients undergoing laparoscopic cholecystectomy who had concomitant choledocholithiasis for which ercp is done.

You may not qualify if:

• Non consenting indviduals

Sponsors & Collaborators

• Khyber Teaching Hospital: lead

Study Sites (1)

Khyber teaching hospital

Peshawar, Khyberpukhtunkhwa, 25000, Pakistan

RECRUITING

MeSH Terms

Conditions

Choledocholithiasis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Saeed Sarwar, MBBS

CONTACT

+923420973863; saeedkmc2020@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 19, 2025
• Study Start: May 23, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)