A Pilot Study on the Use of a Terpene Preparation for the Prevention of Common Bile Duct Stone Recurrence
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0002289
- Lead Sponsor
- Konkuk University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
1. Less than 4 weeks after complete clearance of CBD stones by ERCP (endoscopic sphincterotomy and/or endoscopic papillary balloon dilation can be used to remove CBD stones)
2. Complete CBD stone clearance documented by direct cholangiogram
3. Index event of endoscopic CBD stone removal
(also eligible If repeat ERCPs are done within 2 weeks of index ERCP and complete CBD stone clearance is documented)
4. Between 20 and 80 years of age
5. Regardless of gallbladder status (in situ or postcholecystectomy)
1. Unable to obtain informed consent
2. CBD stone removed by methods other than ERCP
3. Expected survival of less than 6 months
4. History of taking ursodeoxycolic acid or terpene preparation within 6 months of enrollment
5. Previous history of endoscopic manipulation of the biliary tree
6. Presence of intrahepatic stones
7. Comorbid condition precluding administration of terpene preparation
8. Taking oral anticoagulants
9. Taking oral bupriopion
10. Pregnant or planning to become pregnant
11. Presence of biliary drainage, including percutaneous transhepatic biliary drainage
12. History of hepatobiliary surgery other than simple cholecystectomy
13. History of subtotal gastrectomy, total gastrectomy, or pancreaticoduodenectomy
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrence of common bile duct stone
- Secondary Outcome Measures
Name Time Method Development of acute cholangitis