None listed
Conditions
Interventions
Medical Device : Medical devices: HOT-AXIOSTM stent (Lumen diameter 10 mm, Saddle length 10mm, Flange diameter 21mm)
Classification number (class):Grade 3
This product is between gallbladder, gastro
Sponsors
Jeonbuk National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women over the age of 20 who voluntarily obtained consent (for elderly subjects, read and sign the signed consent form after verbally explaining the research content before reading the written consent form, and have their guardians listen to the explanation together) 2. a patient who has agreed to a clinical trial 3. Patients with indications for EUS-GBD conversion 4. Patients deemed inappropriate for cholecystectomy through multidisciplinary discussions
Exclusion criteria
Exclusion criteria: 1. a pregnant woman 2. Blood clotting disorder (PLT1.5 sec) 3. Patients who have difficulty performing ultrasound endoscopy due to cardiopulmonary dysfunction 4. Patients with contraindications for EUS-GBD implementation 5. a patient who has not agreed to a clinical study 6. Patients unable to access biopsy under ultrasound endoscopy (e.g., anatomical deformation due to intervening blood vessels, gastrectomy, etc.) 7. a patient under the age of 20 8. a patient with a large ascites
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical success rate for switching from PTGBD to EUS-GBD using EC-LAMS | — |
Secondary
| Measure | Time frame |
|---|---|
| clinical success rate;recurrence rate of acute cholecystitis ; Need for a re-treatment; incidence of treatment-related adverse reactions | — |
Countries
Korea, Republic of
Contacts
Public ContactSEONGHUN KIM
Jeonbuk National University Hospital
Outcome results
None listed