Study of preventive effect of ursodeoxycholic acid on common bile duct stones.

Phase 3

• Conditions: Common bile duct stones

• Registration Number: JPRN-jRCTs061180077
• Lead Sponsor: Keishi Kanno

Brief Summary

In this study, we evaluated the efficacy and safety of ursodeoxycholic acid in the prevention of recurrence after treatment of common bile duct stones. In prevention of recurrence, one case of recurrence was observed in both the ursodeoxycholic acid-treated and non-treated groups. No significant changes in secondary endpoints were observed during the 96 week obsevation period, and the only side effect was mild diarrhea, indicating that ursodeoxtcholic acid was safe to use.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-20
• Study Completion: 2021-01-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. Age : 20 years old or older at the time of informed consent
2. First treatment of common bile duct stone removal
3. Complete removal of CBD stones by endoscopic papillary treatment
4. Symptomfree period for more than 3 months after removal treatment and no common bile duct stone was proved by CT scan in the preliminary investigation period
5. Written informed consent

Exclusion Criteria

1. A history of gastrectomy
2. Current treatment for cancer
3. Complete obstruction of the biliary tract
4. Current treatment for fulminant hepatitis
5. Women who were pregnant or breastfeeding, had signs of pregnancy, or were planning to become pregnant
6. Alcohol abuse
7. A history of hypersensitivity to the study drug
8. Current treatment with another bile acid formulation (Urso or Chino capsule), cholagogue (dehydrocholic acid, Supacal, Felviten, and Inchinkoto) , bile acid adsorbent (cholestimide or Questran), or agents under development
9. Patients who were judged to be ineligible for the study by the investigator for other reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence rate of common bile duct stone during the followup period

Secondary Outcome Measures

Name	Time	Method
The rate of change and the amount of change in the following test items during the 96 week test period<br>Blood glucose level, LDL cholesterol, HDL cholesterol, triglyceride, AST, ALT, GGT, ALP, T-Bil, D-Bil, bile composition, bile culture<br>Presence or absence of symptoms based on imaging diagnosis during the 96 week test period