EUS-guided Procore-biopsy in Diagnosing Autoimmune Pancreatitis

Autoimmune Pancreatitis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01774513
• Other study ID #: 1212013
• Status: Recruiting
• Phase: N/A
• First received: January 22, 2013
• Last updated: January 22, 2013
• Start date: January 2013

Study information

• Verified date: January 2013
• Source: Technische Universität München
• Contact: Stefan von Delius, MD
• Email: stefan_ruckert[@]yahoo.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Autoimmune Pancreatitis
• Pancreatitis

Intervention

Device:
• Procore-Needle

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic yield	Number of patients with adequate tissue sample (which allows definitive diagnosis)	6 months	No