Evaluation of the new 22-gauge EUS guided Biopsy Needle (Acqiure) Comparing to another new 20-gauge FNA needle with forward-cutting bevel (ProCore) in Patients With Autoimmune Pancreatitis : A Prospective Randomized, Controlled Multicenter Study
Phase 3
- Conditions
- type 1 autoimmune pancreatitis
- Registration Number
- JPRN-UMIN000027668
- Lead Sponsor
- Bilio-Pancreatic Stenting study group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
Not provided
Exclusion Criteria
1) Uncorrectable coagulopathy (INR > 1.5). Or uncorrectable thrombocytopenia (platelet < 50,000) 2) Uncooperative patients 3) Inaccessible lesions to EUS 4) Patients with ASA criteria 3, 4, or 5 5) Refusal to consent form
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic yield of the 22G Acquire and the 20G ProCore needle
- Secondary Outcome Measures
Name Time Method 1) Diagnostic accuracy and specificity of the 22G Acquire and the 20G ProCore needle 2) Contribution of histologic findings to the diagnosis of AIP according to the ICDC 3) Diagnostic sufficiency of Tissue obtained by the EUS needles 4) Evaluation of marked lymphoplasmacytic infiltration with fibrosis and without granulocytic infiltration. 5) Evaluation of abundant (>10 cells/HPF) IgG4-positive cells 6) storiform fibrosis 7) obliterative phlebitis 8) Success rate of EUS-FNA 9) Rate of complications related with EUS-FNA. the EUS needles 10) Comparing diagnostic accuracy of 1st pass and total passes in two groups, respectively.