Clinical trial NCT06599437: 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
Official title: Index Laparoscopic Cholecystectomy Following Clearance of Common Bile Duct Stones Via Endoscopic Retrograde Cholangiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Choledocholithiasis with Cholecystitis
Keywords: choledocholithiasis
ERCP
Early cholecystectomy
Lead sponsor: Damanhour Medical National Institute
Sponsor class: OTHER_GOV
First posted: 2024-09-19
Enrollment: 50
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: recurrence of biliary events
timeFrame: up to 3 months after surgery
Secondary outcomes:
measure: operative time
timeFrame: during surgery
measure: pancreatitis
timeFrame: 3 months after surgery
measure: conversion to open surgery
timeFrame: During surgery
measure: Bleeding
timeFrame: during surger and up to 3 weeks
measure: the presence of intraoperative adhesions
timeFrame: During surgery
measure: Bile leak
timeFrame: up to 1 week after surgery
measure: Wound infection
timeFrame: up to 3 months after surgery
measure: hospital stays
timeFrame: from admission to the end of post operative follow up at 3 months after surgery
measure: post oprative pain
timeFrame: after surgery and up to 3 days
Other outcomes:
Locations:
city: Damanhur
country: Egypt
facility: Damanhur Medical National Institute
state: Behira
Study officials:
References: