autoimmune pancreatitis
Conditions
Interventions
Steroid treatment (total 56 weeks) Induction ~ 4 weeks : Prednisolone 10mg/day 4 weeks ~ 48 weeks : Prednisolone 5mg/day 48 weeks ~ 52 weeks : Prednisolone 2.5mg/day 52 weeks ~ 56 weeks : Predni
Sponsors
Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Asymptomatic and untreated patients with AIP diagnosed on the basis of the diagnostic criterion of AIP 2011 published by Japan Pancreas Society 2) Age of 20 and more 3) ECOG performance status of 0 or 1 4) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients who have already administered steroid and/or immunosuppressive drugs 2) Severe drug hypersensitivity 3) Active infection 4) Infection of HBV (patients with HBc antigen-positive or with HBs antibody-positive, or patients previously unvaccinated against HBV with HBs antibody-positive alone) 5) Patients who require the treatment of cerebrovascular or cardiovascular disorder 6) Patients with uncontrollable diabetes mellitus 7) Patients with uncontrollable hypertension 8) Patients with severe mental disorder 9) Patients with severe cataract or glaucoma 10) Patients with severe renal disorder 11) Patients with severe lung disorder 12) Patients with severe liver disorder 13) Patients with severe osteoporosis 14) Past history of pancreatectomy 15) Pregnant or lactating women, or women with suspected pregnancy 16) Patients seems inadequate for this study judged by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sequential change of pancreatic exocrine function | — |
Countries
Japan
Contacts
Public ContactTakahiro Suda
Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology
Outcome results
None listed