Clinical Trials Directory

Trials / Completed

CompletedNCT03937037

Effect of Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP

Effect of Intermittent Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP

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

Summary

In this prospective study, the investigators assessed the utility of intermittent saline irrigation in reducing the recurrent rate of choledocholithiasis after the endoscopic extraction for common bile duct stones, and it does not increase the rate of procedure-related complications.

Detailed description

In recent years, an endoscopic retrograde cholangiopancreatography (ERCP) is the golden standard procedure to remove the common bile duct stones(CBD). Nevertheless, it is reported that the recurrence rate of CBD stones is 4% to 24% after ERCP. The contributing factors were periampullar diverticulum, situ gallbladder, and incomplete CBD stone clearance. The main reason of stone recurrence is incomplete CBD stone clearance including remnant stone fragments themselves and tinny fragments can act as a nidus for further CBD stone growth. It is difficult to retrieve these fine fragments completely using conventional devices such as retrieval basket and ballon. Therefore, the investigators attempt to remove residual stone fragments by means of saline infusion. Saline irrigation has many advantages such as better effect and less side effect and no extra cost. It is reported that use intraductal ultrasonography (IDUS) to demonstrate residual CBD stones. However, IDUS has limited availability in clinical practice. The single-operator cholangioscopy (SOC)-system gains widespread acceptance because of its independent washing channels and direct viewing. The purpose of this study is to evaluate whether saline solution irrigation would decrease the recurrent rate of choledocholithiasis after endoscopy retrieval stones.

Conditions

Interventions

TypeNameDescription
PROCEDURESaline irrigation100ml saline irrigation after CBD stone removal with routine ERCP procedure

Timeline

Start date
2019-05-10
Primary completion
2022-12-31
Completion
2022-12-31
First posted
2019-05-03
Last updated
2023-01-25

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03937037. Inclusion in this directory is not an endorsement.