NCT03701009

Saline Irrigation Reduces the Residual Bile Duct Stones During Endoscopic Retrograde Cholangiopancreatography (ERCP)

Saline Irrigation Reduces the Residual Bile Duct Stones After ERCP: a Single-arm Prospective Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the usefulness of saline solution irrigation in decreasing residual common bile duct (CBD) stones.

Detailed description

In recent years, ERCP is the standard procedure to remove the bile duct stones. The big stones(\>1.2 cm) require additional lithotripsy procedures for complete stone removal. Nevertheless, small stone fragments still remain in the common bile duct when the cholangiogram shows normal. The fragments are too small to be verified. These retained fragments may cause recurrence of stones. Another way to demonstrate residual CBD stones is to use intraductal ultrasonography (IDUS). However, IDUS has limited availability in clinical practice. The single-operator cholangioscopy (SOC)-system Spyglass gains widespread acceptance because of its independent washing channels and direct viewing. The investigators used Spyglass to detect if saline(50 or 100ml) infusion might clear the bile duct fragments after ERCP. Saline irrigation has many advantages such as easy stone removal, no additional cost and rare side effects. The purpose of this study is to evaluate the usefulness of saline solution irrigation in decreasing residual CBD stones.

Conditions

• Stone Clearance

Interventions

Type	Name	Description
PROCEDURE	CBD stone removal via lithotripsy	Hold saline irrigation just after X-ray demonstrated no stone residue, a Spyglass explored.
PROCEDURE	Saline 50ml	If not clean, intermittent saline irrigation 50ml, and Spyglass explored second time.
PROCEDURE	Saline +50ml	If still have some stone fragments, intermittent saline irrigation another 50ml after the second Spyglass detection, Spyglass explored third time to evaluate stone clearance.

Timeline

• Start date: 2018-10-10
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2018-10-09
• Last updated: 2020-07-14

Locations

1 site across 1 country: China