Early Versus Late Cholecystectomy After Clearance of Common Bile Duct Stones

Not Applicable

Completed

• Conditions: Gallbladder and Bile Duct Calculi
• Interventions: Procedure: late cholecystectomy; Procedure: early cholecystectomy

• Registration Number: NCT02460315
• Lead Sponsor: Mansoura University

Brief Summary

Approximately 10-15% of all patients with gallstones have coexisting common bile duct (CBD) stones. However CBD stones can also be formed in the absence of gallbladder stones. The current standard of treatment for calcular obstructive jaundice is endoscopic removal of the stones. Endoscopic sphincterotomy (ES) is widely accepted as the treatment of choice for patients with CBDS. Stone extraction is successful in up to 97% of patients The time interval between ERCP and laparoscopic cholecystectomy (LC) is a matter of debate that may vary from days to months. Some retrospective and other prospective studies have investigated this issue without sharp clue or definite conclusion This study planned to compare early LC (within admission) versus late LC (after 1 month) after ERCP as regard technical difficulties and surgical outcomes.

Detailed Description

The aim is comparing early versus delayed laparoscopic cholecystectomy after endoscopic retrograde cholangiopancreatography in patients with gall bladder stones and calcular obstructive jaundice as regards operative difficulties, conversion rate, signs of inflammation, degree of adhesions, blood loss, postoperative morbidity, and hospital stay. Moreover, bacterial examination of bile and culture sensitivity test for assessment of bacterial colonization and relate the degree of colonization to timing of laparoscopic cholecystectomy after endoscopic retrograde cholangiopancreatography, to decide upon the optimal timing for the surgery.

The study population will be divided into 2 groups; group (A) will be managed by early laparoscopic cholecystectomy (LC) within 3 days after ERCP and group (B) will be managed by late LC one month after ERCP.

Study Timeline

• Status Verified: 2013-05
• Study Start: 2013-05
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Study First Submitted: 2015-05-22
• Study First Submitted QC: 2015-06-01
• Last Update Submitted: 2015-06-01
• Study First Posted: 2015-06-02
• Last Update Posted: 2015-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients with CBD stone and treated by ERCP

Exclusion Criteria

• Patient unfit for surgery,
• Pregnant patients,
• Patients with severe malnutrition,
• Patients with liver cirrhosis,
• Patients in whom endoscopic management of CBD stones failed
• Patients who experienced pancreatitis or perforation as a complication of the endoscopic management of CBD stones
• Patients who underwent previous upper abdominal surgeries
• Mentally retarded patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
late cholecystectomy	late cholecystectomy	group (B) will be managed by late LC one month after ERCP.
early cholecystectomy	early cholecystectomy	group (A) will be managed by early laparoscopic cholecystectomy after clearness ERCP

Primary Outcome Measures

Name	Time	Method
conversion rate to open	1 day	number of patients underwent conversion to open

Secondary Outcome Measures

Name	Time	Method
postoperative morbidity	1 days	postoperative morbidity
signs of inflammation (redness, pus)	30 days	signs of inflammation redness, pus, wall thickness
degree of adhesion (mild,moderate, severe)	1 days	degree of adhesions