Actively Recruiting
Multicenter Prospective Study for Efficacy of Asymptomatic Common Bile Duct Stone Treatment
Led by Kyungpook National University Hospital · Updated on 2024-01-22
120
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
K
Kyungpook National University Hospital
Lead Sponsor
Y
Yeungnam University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to identify the characteristics of asymptomatic common bile duct stones and evaluate the effectiveness of their treatment. The study focuses on patients who have common bile duct stones detected incidentally during health screenings without symptoms. It addresses the lack of prospective studies comparing outcomes for those who undergo stone removal versus those who do not, especially concerning quality of life and risk of cholangitis. The study is conducted across multiple centers and sponsored by Kyungpook National University Hospital. Participants diagnosed with common bile duct stones through imaging may choose to undergo removal via endoscopic retrograde cholangiopancreatography, a procedure to remove the stones. Those who opt out of this treatment will be followed to monitor potential complications and the rate of cholangitis. The study will also assess the complication rates associated with this endoscopic procedure in asymptomatic patients. During the study, participants will complete questionnaires before and after treatment to measure quality of life changes, with primary outcomes assessed at three months. Researchers will monitor patients who decline removal for signs of cholangitis and complications. The total duration of follow-up and assessments will help determine the effectiveness and safety of treatment strategies for asymptomatic common bile duct stones.
CONDITIONS
Brief Title
The Treatment Effect for Asymptomatic Common Bile Duct Stone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with common bile duct stone by imaging examination
- Agree to participate in this study
You will not qualify if you...
- No definite common bile duct stone by imaging examination
- Symptomatic patients with fever or abdominal pain related to bile duct stones
- Previously diagnosed with pancreatobiliary malignancy
- Previously treated by endoscopic or percutaneous methods for bile duct stones
- Severe heart or lung disease
- Pregnancy or possibility of pregnancy
- Do not agree to participate in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to enrollment
Participants diagnosed with asymptomatic common bile duct stone by imaging examination.
Duration - Up to 3 months or longer depending on individual follow-up
Participants who do not undergo common bile duct stone removal are followed to monitor the risk of cholangitis and complications.
Periodic assessments during follow-up
Duration - Single procedure with follow-up for complications
Participants who undergo endoscopic retrograde cholangiopancreatography have common bile duct stone removal.
1 procedure visit and follow-up assessments
Trial Site Locations
Total: 1 location
1
Kyungpook National University Hospital
Daegu, Gyungsangbok-do, South Korea
Actively Recruiting
Research Team
J
Jun Heo
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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