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

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 - Comparing the diagnostic yield of EUS-FNA using ProCore and Acquire in patients with AIP (COMPAS study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027668

Enrollment

110

Registered

2017-08-01

Start date

2017-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 1 autoimmune pancreatitis

Interventions

Acquire needle ProCore needle

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with suspect of type 1 autoimmune pancreatitis Agree to consent form Patients with ECOG performance status 0 or 1

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Diagnostic yield of the 22G Acquire and the 20G ProCore needle	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactAkira Kurita

Kitano Hospital, The Tazuke Kofukai Medical Research Institute Division of Gastroenterology and Hepatology, Digestive Disease Center

kuritaaki1976@gmail.com06-6131-2662

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026