Effect of Common Bile Duct Stone Clearance Using Saline Irrigation After Stone Removal: A Prospective Randomized Control Trial.

Study Overview
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Brief Summary
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Retained CBD stone after ERCP is a common problem in clinical practice. This study aimed to evaluate the effect of saline irrigation of common bile duct after complete stone removal considered by ERCP in the reduction of residual CBD stone and the effect on clinical outcome.

Detailed Description
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This study aimed to evaluate the effect of saline irrigation of common bile duct after complete stone removal considered by ERCP in the reduction of residual CBD stone and the effect on clinical outcome. Patients with CBD stone who received endoscopic stone removal were included after complete stone clearance was seen on occluded cholangiogram. One arm received saline irrigation of CBD at least 50 ml until clear effluent seen and another arm as control. Both group received endoscopic ultrasound to evaluation for residual stone and followed up for complication and outcome.

Official Title
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Effect of Common Bile Duct Stone Clearance Using Saline Irrigation After Stone Removal: A Prospective Randomized Control Trial.

Conditions
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Common Bile Duct Calculi

Intervention / Treatment
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* Procedure: Saline irrigation group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with common bile duct stone Complete stone removal by endoscopy as seen in occluded cholangiogram Exclusion Criteria: unstable vital sign failed complete stone remval assciated biliary malignancy or history of bile duct surgery associated bile duct stricture or choledochal cyst Toxic cholangitis pregnancy or unable to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

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
Interventional Model Description: Included patients are randomized to two group, study group and control group an followed up parallelly.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: saline irrigation group<br>The patients received saline irrigation of common bile duct after complete ERCP stone removal confirmed by occluded cholangiogram | Procedure: Saline irrigation group<br>* Normal saline irrigation of common bile duct after complete stone removal<br>|
| No Intervention: control<br>The patients whom complete ERCP stone removal confirmed by occluded cholangiogram were follow up according to standard treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of residual CBD stone | Detected residual CBD stone by endoscoic ultrasound | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| factors associated with retained CBD stone | procedural and non-procedural factors related to retained CBD stone | 1 day | 
| Complicaion and clinical outcome | Complication associated with the procedure, hospital stay, and clinical outcome after the procedure | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholangitis, endoscopic retrograde cholangiopancreatography, endoscopic ultrasound