A Pilot Study on the Use of a Terpene Preparation for the Prevention of Common Bile Duct Stone Recurrence

A Terpene Preparation for the Pharmacological Prevention of Recurrence of Common Bile Duct Stone after Endoscopic Removal: A Prospective, Multicenter, Randomized Pilot Study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0002289

Enrollment

Registered

2017-04-04

Start date

2017-03-07

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Treatment arm: 2 capsules of Rowachol taken 3 times a day 30 minutes before meals for 24 weeks Control arm: Rowachol will not be given

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Recurrence of common bile duct stone	—

Secondary

Measure	Time frame
Development of acute cholangitis	—

Countries

Korea, Republic of

Contacts

Public ContactYoung Koog Cheon

Konkuk University Medical Center

yksky001@hanmail.net+82-2-2030-7490

Outcome results