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EUS-guided Procore-biopsy in Diagnosing Autoimmune Pancreatitis

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ClinicalTrials.gov Identifier: NCT01774513
Recruitment Status : Unknown
Verified January 2013 by Technische Universität München.
Recruitment status was:  Recruiting
First Posted : January 24, 2013
Last Update Posted : January 24, 2013
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

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

Condition or disease Intervention/treatment Phase
Autoimmune Pancreatitis Device: Procore-Needle Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : January 2013
Estimated Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Procore Needle Device: Procore-Needle



Primary Outcome Measures :
  1. diagnostic yield [ Time Frame: 6 months ]
    Number of patients with adequate tissue sample (which allows definitive diagnosis)



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774513


Contacts
Contact: Stefan von Delius, MD stefan_ruckert@yahoo.de

Locations
Germany
Klinikum rechts der Isar Recruiting
Munich, Bavaria, Germany, 81675
Contact: Stefan von Delius, MD       stefan_ruckert@yahoo.de   
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

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01774513     History of Changes
Other Study ID Numbers: 1212013
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases