Evaluating treatment for asymptomatic common bile duct stones
Multicenter Prospective Study for Efficacy of Asymptomatic Common Bile Duct Stone Treatment
This study is testing how well treating asymptomatic common bile duct stones works compared to not treating them at all, to help doctors decide the best way to manage these cases.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Kyungpook National University Hospital Academic / other |
| Locations | 1 site (Daegu, Gyungsangbok-do) |
| Trial ID | NCT06215040 on ClinicalTrials.gov |
What this trial studies
This prospective, multicenter study aims to identify the characteristics and treatment effectiveness of asymptomatic common bile duct stones. It will compare patient-reported outcomes before and after the removal of these stones using endoscopic retrograde cholangiopancreatography. Additionally, the study will follow patients who opt not to undergo removal to assess the risk of cholangitis and document the complication rates associated with the procedure. The findings will help clarify the management of asymptomatic cases identified through routine imaging.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with asymptomatic common bile duct stones through imaging who agree to participate in the study.
Not a fit: Patients with symptomatic common bile duct stones or those with other severe health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidelines for the treatment of asymptomatic common bile duct stones, potentially improving patient quality of life.
How similar studies have performed: While there is existing literature on symptomatic cases, this study addresses a novel area by focusing on asymptomatic patients, making it a unique investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosed as common bile duct stone by image modality examination * agreement for this study enrollment Exclusion Criteria: * no definite common bile duct stone by image modality examination * symptomatic patients who complain with fever/abdominal pain that compatible with common bile duct stone related symptom * previously diagnosed as pancreatobiliary malignancy * previously treated by endoscopic or percutaneous treatment for bile duct stones * severe cardio or pulmonary disease * pregnancy or possibility of pregnancy * who do not agree with study enrollment
Where this trial is running
Daegu, Gyungsangbok-do
- Kyungpook National University Hospital — Daegu, Gyungsangbok-do, South Korea (Recruiting)
Study contacts
- Study coordinator: Jun Heo
- Email: hero797@hanmail.net
- Phone: 82532005505
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.