None listed
Conditions
Interventions
Medical Device : Portal vein embolization using PRIME-GEL 710–1000 µm loaded with non-steroidal anti-inflammatory drugs (NSAIDs)
Ibuprofen 400mg
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients aged 19 years or older 2. Patients who have provided written informed consent 3. Patients scheduled to undergo preoperative portal vein embolization (PVE) 4. Patients with a Child–Pugh score = 9 (class A or B) 5. Patients with an expected survival of at least 6 months who are able to complete follow-up until the end of the study
Exclusion criteria
Exclusion criteria: 1. Patients younger than 19 years of age 2. Patients with contraindications to gelatin 3. Patients with contraindications to angiography or catheter manipulation 4. Pregnant or breastfeeding women 5. Child–Pugh class C 6. Presence of sepsis or active infection 7. Platelet count < 50,000/µL or INR = 2.0 8. Evidence of irreversible bleeding tendency or coagulation disorders 9. Medically uncontrolled encephalopathy 10. Presence of medically uncontrolled ascites 11. Allergy to contrast media not manageable with prophylaxis 12. Any other condition that, in the opinion of the investigator or principal investigator, would make participation in the clinical trial inappropriate or difficult
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum post-procedural pain score assessed by the Numeric Rating Scale (NRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| requirement and frequency of analgesic use during and after the procedure;incidence of post-embolization syndrome;safety assessments according to CTCAE v5.0;efficacy assessment based on changes in future liver remnant volume before and after portal vein embolization | — |
Countries
Korea, Republic of
Contacts
Public ContactJin Bae Heo
Asan Medical Center
Outcome results
None listed