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

JRCT ID: jRCTs061180077

Registered date:20/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Common bile duct stones
• Date of first enrollment: 26/04/2017
• Target sample size: 420
• Study type: Interventional
• Intervention(s): UDCA is administered orally for 96 weeks at a dose of approximately 10 mg/kg body weight, devided into 1 to 3 times a day.

Outcome(s)

• Primary Outcome: Recurrence rate of common bile duct stone during the followup period

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Keishi Kanno
• Secondary ID(s): UMIN000020774