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EUS-guided Procore-biopsy in Diagnosing Autoimmune Pancreatitis

This study is currently recruiting participants.
Verified January 2013 by Technische Universität München
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01774513
First received: January 22, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Technische Universität München
ClinicalTrials.gov 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:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 22, 2013