autoimmune pancreatitis
Conditions
Interventions
Endoscopic retrograde biliary drainage + glucocorticoid group:Endoscopic retrograde biliary drainage + glucocorticoids
glucocorticoid group:glucocorticoids alone
Sponsors
The First Medical Center,Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with a definitive diagnosis of AIP, type 1 or type 2, in accordance with the ICDC (2011) diagnostic criteria; 2.With painless significant obstructive jaundice (serum total bilirubin = 3ULN, [TB] = 63 µmol/L,Normal value: 0-21 µmol/L); 3. Aged >=18 years, male or female; 4. Signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Critically ill with unstable vital signs; 2. Patients with a combination of severe cardiopulmonary or other underlying disease or altered consciousness that precludes endoscopy, or patients with an American Society of Anesthesiologists Physiologic Status Classification (ASA) >=3 who are assessed by an anesthesiologist to be unable to undergo painless endoscopy; 3. Patients with a combination of other malignant tumors; 4. Patients with comorbid other primary biliopancreatic disease, or in whom biliopancreatic malignancy cannot be ruled out: e.g., choledocholithiasis, primary biliary cholangitis, etc; 5. Patients with anatomical changes of the digestive tract, or combined with upper gastrointestinal stenosis, severe esophagogastric fundal varices, etc. (ERCP insertion difficulties) 6. Patients with coagulation dysfunction (platelet count 1.5), or inability to discontinue anticoagulants for >5 days; 7. Patients with contraindications to or intolerance of hormone therapy: drug allergy, severe psychosis, epilepsy, severe hypertension, hyperadrenocorticism, severe infections, systemic fungal infections, severe osteoporosis, and active peptic ulcer; 8. Pregnant, lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse effects ; | — |
Countries
China
Contacts
Public ContactLi Mingyang
The First Medical Center,Chinese PLA General Hospital
Outcome results
None listed