EUS-guided Procore-biopsy in Diagnosing Autoimmune Pancreatitis

Not Applicable

• Conditions: Autoimmune Pancreatitis
• Interventions: Device: Procore-Needle

• Registration Number: NCT01774513
• Lead Sponsor: Technical University of Munich

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-01
• Study Start: 2013-01
• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-01-22
• Last Update Submitted: 2013-01-22
• Study First Posted: 2013-01-24
• Last Update Posted: 2013-01-24
• Primary Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Procore Needle	Procore-Needle	-

Primary Outcome Measures

Name	Time	Method
diagnostic yield	6 months	Number of patients with adequate tissue sample (which allows definitive diagnosis)

Trial Locations

Locations (1)

Klinikum rechts der Isar; 🇩🇪 Munich, Bavaria, Germany