EUS-guided Procore-biopsy in Diagnosing Autoimmune Pancreatitis

Technical University of Munich

Status: Unknown

Conditions: Autoimmune Pancreatitis

Treatments: Device: Procore-Needle

Study type: Interventional

Funder types: Other

Identifiers

NCT01774513

1212013

Details and patient eligibility

About

The goal of this prospective study is to evaluate the feasibility of the Core Biopsy Needle with reverse bevel (Procore TM) in diagnosing autoimmune pancretitis

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient age 18 years and older
• patients with suspicion of autoimmune pancreatitis (based on the findings in EUS and MRI)

Exclusion criteria

• unable to obtain informed consent
• ASA class 4 and 5
• known pregnancy
• contraindication for endoscopy or for biopsy sampling
• patients with high suspicion on pancreatic cancer (based on the findings in radiology and EUS)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Procore Needle

Experimental group

Treatment:

Device: Procore-Needle