Prospective study of biliary stent placement for treatment of small common bile duct stones

Phase 2

Recruiting

• Conditions: Choledocholithiasis; D042883

• Registration Number: JPRN-jRCT1042200020
• Lead Sponsor: kawaguchi shinya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1) Patients who was placed biliary stent for common bile duct stones.
2) Patients of common bile duct stones which were detected by CT, MRI, abdominal ultrasonography, endoscopic ultrasonography (EUS) , or cholangiography, and the short diameter of bile duct stones was 5 mm or less.
3) Written informed consent is obtained.

Exclusion Criteria

1) Bile duct malignant tumor
2) History of Bilroth-II reconstruction gastrectomy, Roux-en-Y reconstruction gastrectomy, cholangiojejunostomy, or pancreaticoduodenectomy
3) Benign biliary stricture
4) History of medium or large sphincterotomy
5) Asymptomatic or gallstone pancreatitis
6) A responsible doctor has confirmed the candidate should be excluded from this study.
7) Patients without cholangitis who are expected to have a bile duct stone diameter of 6 mm or more by ERCP after obtaining consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of disappearance of common bile duct stones until 6 months after placement of a biliary stent. Disappearance of common bile duct stones is confirmed by endoscopic ultrasonography (EUS) or cholangiography with intraductal ultrasonography (IDUS).

Secondary Outcome Measures

Name	Time	Method
Period from placement of biliary stent to stone disappearance<br>The rate of recurrence of common bile duct stone, and period from disappearance to recurrence<br>The rate of adverse events <br>The rate of asymptomatic migration of stent