None listed
Conditions
Interventions
Drug : 1. Study Design and Overview
This study is a prospective, multicenter, randomized, open-label trial comparing the recurrence rate of common bile duct stones between two treatment groups: terpen
thus, both investigators and participants will be aware of the assigned treatments.
Therefore, blinding will not be implemented, and unblinding procedures are unnecessary. The decision to forego blind
Sponsors
Yonsei University Health System, Gangnam Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Selection Criteria This prospective study compares the recurrence rates of common bile duct stones between a group treated with Terpene preparations (Rowachol®) and UDCA and a group treated with Terpene preparations (Rowachol®), UDCA, and CDCA following endoscopic treatment for common bile duct stones. Eligible participants must meet all of the following criteria. (1) Patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) to remove common bile duct stones (2) Patients enrolled in the study within 4 weeks of ERCP (3) Patients who underwent endoscopic sphincterotomy, endoscopic papillary balloon dilation, or a combination of both procedures for the removal of common bile duct stones (4) Patients with complete removal of common bile duct stones confirmed by cholangiogram (5) Adults aged 20 years or older (6) The presence or absence of cholecystectomy is not included in the inclusion or exclusion criteria for study participants (7) Patients who can receive concomitant administration of Terpene-containing agents (Rowachol®) and UDCA or Terpene-containing agents (Rowachol®) and UDCA plus CDCA following ERCP
Exclusion criteria
Exclusion criteria: Exclusion Criteria Patients meeting any of the following criteria will be excluded from the study. (1) Patients unable to obtain informed consent for the study (2) Patients who have had common bile duct stones removed by methods other than ERCP (3) Patients with a clinical prognosis of less than 6 months of survival (4) Patients who have taken UDCA, UDCA/CDCA, or terpene preparations within 6 months prior to study enrollment (5) Patients with a history of endoscopic treatment of the biliary tract (ERCP, endoscopic stent placement, etc.) (6) Patients with a history of treatment for common bile duct stones (7) Patients with gallbladder stones (8) Patients with impaired physical function resulting in limitations in daily activities, classified as ECOG 3 or higher, and at high risk for gallstone recurrence (9) Patients with intrahepatic gallstones that have not been completely removed (10) Patients with concomitant malignant tumors of the pancreas or biliary tract (11) Patients for whom terpene-containing agents (Rowachol®) or UDCA, UDCA/CDCA are contraindicated (12) Patients currently taking oral anticoagulants (13) Patients currently taking oral bupropion (14) Pregnant women or women planning to become pregnant (15) Patients with a biliary drainage catheter (including PTBD) (16) Patients who have undergone hepatobiliary surgery other than simple cholecystectomy (17) Patients who have undergone gastrectomy, total gastrectomy, or pancreatoduodenectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate of common bile duct stones (Primary Endpoint: Recurrence rate of CBD stones) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse drug reactions | — |
Countries
Korea, Republic of
Contacts
Public ContactSee Young Lee
Yonsei University Health System, Gangnam Severance Hospital
Outcome results
None listed