steatotic liver disease
Conditions
Interventions
Patients with refractory steatotic liver disease that persists for more than one year after pancreaticoduodenectomy will be randomized. Subjects assigned to the pemafibrate group (intervention group)
Sponsors
Matsumoto Kazuyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 age old over 2. Patients has passed More than 1 year since pancreaticoduodenectomy 3. Patients with steatotic liver disease with CT value <40HU on non-contrast CT 4. Patienst who have been fully informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with complications of other liver diseases such as active viral hepatitis, autoimmune hepa titis, primary cholestatic cholangitis, drug-induced liver injury 2. Alcohol consumption, 30 g/day or more (men) or 20 g/day or more (women) in terms of ethanol 3. Patients taking concomitantly prohibited drugs 4. Patients with a history of allergy to pemafibrate 5. Patients with liver cirrhosis of Child-Pugh Classification B or C 6. Patients with biliary stones or biliary obstruction 7. Prior treatment with fibrates or SPPARM within 12 weeks of obtaining consent 8. Being pregnant or possibly pregnant 9. Patients who judged as inappropriate candidate by the chief medical examine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of those with liver CT value 40HU or more on non-contrast CT at 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage change in liver CT value on non-contrast CT 2. Percent change in Alb, ALT, GGT, Zn, TG, T-Cho, HDL-Cho, LDL-Cho, ALBI score and FIB-4 index 3. Percent change in weight and BMI 4. Adverse events and side effects | — |
Contacts
Public ContactYosuke Yamamoto
Okayama University Hospital
Outcome results
None listed