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

Rajavithi Hospital

Status: Completed

Conditions: Common Bile Duct Calculi

Treatments: Procedure: Saline irrigation group

Study type: Interventional

Funder types: Other

Identifiers

NCT05639816

134/2562

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

saline irrigation group

Experimental group

Description:

The patients received saline irrigation of common bile duct after complete ERCP stone removal confirmed by occluded cholangiogram

Treatment:

Procedure: Saline irrigation group

control

No Intervention group

Description:

The patients whom complete ERCP stone removal confirmed by occluded cholangiogram were follow up according to standard treatment