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EUS-guided Procore-biopsy in Diagnosing Autoimmune Pancreatitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Technische Universität München.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01774513
First Posted: January 24, 2013
Last Update Posted: January 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Technische Universität München
  Purpose
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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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

  Eligibility

Information from the National Library of Medicine

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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)
  Contacts and Locations
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
  More Information

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01774513     History of Changes
Other Study ID Numbers: 1212013
First Submitted: January 22, 2013
First Posted: January 24, 2013
Last Update Posted: January 24, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases