EUS-guided Procore-biopsy in Diagnosing Autoimmune Pancreatitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2013 by Technische Universität München.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Technische Universität München Identifier:
First received: January 22, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
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

Condition Intervention
Autoimmune Pancreatitis
Device: Procore-Needle

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

Resource links provided by NLM:

Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • diagnostic yield [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of patients with adequate tissue sample (which allows definitive diagnosis)

Estimated Enrollment: 16
Study Start Date: January 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Procore Needle Device: Procore-Needle


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01774513

Contact: Stefan von Delius, MD

Klinikum rechts der Isar Recruiting
Munich, Bavaria, Germany, 81675
Contact: Stefan von Delius, MD   
Principal Investigator: Stefan von Delius, MD         
Sub-Investigator: Christoph Schlag, MD         
Sub-Investigator: Hana Algül, MD         
Sub-Investigator: Gregor Weirich, MD         
Sub-Investigator: Christiane Schwerdtfeger, MD         
Sponsors and Collaborators
Technische Universität München
  More Information

Responsible Party: Technische Universität München Identifier: NCT01774513     History of Changes
Other Study ID Numbers: 1212013 
Study First Received: January 22, 2013
Last Updated: January 22, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Digestive System Diseases
Pancreatic Diseases processed this record on May 25, 2016