EUS-FNB for AIP Study
- Conditions
- Autoimmune pancreatitis
- Registration Number
- JPRN-jRCTs042180092
- Lead Sponsor
- Ishikawa Takuya
- Brief Summary
EUS-FNB with a 22-gauge Franseen needle demonstrated favorable detection rates which would be clinically beneficial for the histological diagnosis of autoimmune pancreatitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 56
1)Patients who meet image criteria of autoimmune pancreatitis (AIP) on International consensus diagnostic criteria (ICDC) and have not treated before.
2)Patients between 20 and 85 years old at the time of enrollment.
3)Performance status of 0 to 1.
4)Preservation of main organ functions at the time of diagnosis.
5)Provision of written consent to participate in the study.
1)Steroid administration within 3 months before the initiation of treatment.
2)Poorly controlled infection (including active tuberculosis).
3)Serious drug allergy.
4)Difficult in observation of the course of endoscopy.
5)Malignant tumor.
6)Serious adverse events.
7)Pregnant and lactating women, women who are possibly pregnant, and women who might want to become pregnant.
8)Severe mental disorder
9)Judgement as being ineligible by the principal or subinvestigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Detection rate of pathological findings with meet level 1 of International consensus diagnostic criteria for autoimmune pancreatitis by EUS-FNB
- Secondary Outcome Measures
Name Time Method 1)Detection rate of pathological findings which meet level 2 of International consensus diagnostic criteria (ICDC) by EUS-FNB<br>2)Detection rate of each pathological finding in ICDC by EUS-FNB<br>3)Contribution degree of EUS-FNB in the diagnosis of autoimmune pancreatitis<br>4)Complications of EUS-FNB