Early Versus Late Cholecystectomy After Clearance of Common Bile Duct Stones

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Versus Late Cholecystectomy After Clearance of Common Bile Duct Stones by Endoscopic Retrograde Cholangiopancreatography

Conditions
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Gallbladder and Bile Duct Calculi

Intervention / Treatment
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* Procedure: early cholecystectomy
* Procedure: late cholecystectomy


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: early cholecystectomy<br>group (A) will be managed by early laparoscopic cholecystectomy after clearness ERCP | Procedure: early cholecystectomy<br>* Those patients are primarily managed by endoscopic sphincterotomy and stone extraction for management of CBD stones. Then, the study population will be divided into 2 groups; group 1 will be managed by early laparoscopic cholecystectomy (LC) within 3 days after ERCP<br>* Other names: G 1;|
| Active Comparator: late cholecystectomy<br>group (B) will be managed by late LC one month after ERCP. | Procedure: late cholecystectomy<br>* Those patients are primarily managed by endoscopic sphincterotomy and stone extraction for management of CBD stones. Then, the study population will be divided into 2 groups; group 2 will be managed by late LC one month after ERCP.<br>* Other names: G 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| conversion rate to open | number of patients underwent conversion to open | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| signs of inflammation (redness, pus) | signs of inflammation redness, pus, wall thickness | 30 days | 
| postoperative morbidity | postoperative morbidity | 1 days | 
| degree of adhesion (mild,moderate, severe) | degree of adhesions | 1 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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time of cholecystectomy after ERCP