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

Not Applicable

Completed

• Conditions: Common Bile Duct Calculi
• Interventions: Procedure: Saline irrigation group

• Registration Number: NCT05639816
• Lead Sponsor: Rajavithi Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Study First Submitted: 2022-03-22
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-28
• Last Update Submitted: 2022-11-28
• Study First Posted: 2022-12-06
• Last Update Posted: 2022-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline irrigation group	Saline irrigation group	The patients received saline irrigation of common bile duct after complete ERCP stone removal confirmed by occluded cholangiogram

Primary Outcome Measures

Name	Time	Method
prevalence of residual CBD stone	1 day	Detected residual CBD stone by endoscoic ultrasound

Secondary Outcome Measures

Name	Time	Method
factors associated with retained CBD stone	1 day	procedural and non-procedural factors related to retained CBD stone
Complicaion and clinical outcome	6 months	Complication associated with the procedure, hospital stay, and clinical outcome after the procedure

Trial Locations

Locations (1)

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand