Efficacy and safety of a novel device (OptimosTM Dilatation Device) in endoscopic retrograde cholangiopancreatography (ERCP) for removal of biliary stones
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0006185
- Lead Sponsor
- Chonnam National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 20
Patients with all of the following:
1) Diagnosis of choledocholithiasis using abdominal imaging studies (e.g., CT, MRI, or endoscopic ultrasonography) or laboratory tests
2) Those who will follow the treatment methods and visit for follow-ups
3) Those who understand and agree to participate in this study
Patients with any of the following:
1) Those who cannot give informed consent and agree to participate in this study
2) Those under the age of 20
3) Those over the age of 90
4) Those with previous history of bile duct stone removal by ERCP
5) Those with bleeding tendency/coagulopathy or platelet count <50,000/mm3 or INR >1.5
6) Those taking antiplatelet agents (e.g.,clopidogrel, prasugrel, ticagrelor) and who have not stopped these medications for more than 5 days
7) Those taking anticoagulants (e.g., dabigatran, ribaroxaban, apixaban, edoxaban) and who have not stopped these medications for more than 48 hours
8) Those taking warfarin and who have not stopped this medication for more than 5 days or has INR > 1.5
9) Pregnant women
10) Those who are unable to undergo this procedure at the endoscopist's disrcetion
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method technical success and therapeutic success
- Secondary Outcome Measures
Name Time Method Dilatation device removal success;Safety