Common Bile Duct Stones Clinical Trial
Official title:
A Prospective Multicenter Comparative Study for Efficacy of Choleretics in Acalculous Gallbladder in Situ After Endoscopic Removal of Biliary Stones
In patients with gallbladder in situ after complete removal of common bile duct (CBD) stones, there is no definite guideline for the management of remnant acalculous gallbladder. This study was planned to evaluate the efficacy of choleretic agents in those patients comparing with non-treatment group during short (2 years) and long-term (5 to 10 years) period. So that, the investigators want to establish the treatment guideline in gallbladder in situ without definite stones following complete removal of CBD stones. Second, the protective or preventive effect of choleretics may be defined.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | December 2021 |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - Complete clearance of CBD stones - No definite GB stones - Agree with the study protocol Exclusion Criteria: - < 18 years of age - Concomitant IHD stones - Combined malignancy with a limted life span - Prior cholecystectomy state - refusal to agree to the study protocol |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Soon Chun Hyang University Cheonan Hospital | Cheonan | Chungcheongnam-do |
| Lead Sponsor | Collaborator |
|---|---|
| Soon Chun Hyang University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Drug-related adverse event | Other outcome measure includes adverse events after choleretics. | three months | No |
| Primary | Complications | The primary outcome is biliary complications between two groups during follow-up. | two year | No |
| Secondary | Natural outcomes | Other outcome measures included adverse events after choleretics and natural clinical courses of gallbladder in situ. | two year | No |
| Secondary | Other adverse events | Other outcome measures included adverse events after choleretics and natural outcomes of gallbladder in situ. | two year | No |
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