None listed
Conditions
Interventions
Medical Device : In patients with choledocholithiasis who needs ERCP guided stone removal, the novel dilatation device (OptimosTM Dilatation Device) is used for papillary dilatation.
The method of s
Sponsors
Chonnam National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| technical success and therapeutic success | — |
Secondary
| Measure | Time frame |
|---|---|
| Dilatation device removal success;Safety | — |
Countries
Korea, Republic of
Contacts
Public ContactEunae Cho
Chonnam National University Hospital
Outcome results
None listed