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

January 22, 2013
January 22, 2013
January 2013
December 2014   (final data collection date for primary outcome measure)
diagnostic yield [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Number of patients with adequate tissue sample (which allows definitive diagnosis)
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
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EUS-guided Procore-biopsy in Diagnosing Autoimmune Pancreatitis
Not Provided

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

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Autoimmune Pancreatitis
Device: Procore-Needle
Experimental: Procore Needle
Intervention: Device: Procore-Needle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16
Not Provided
December 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Stefan von Delius, MD stefan_ruckert@yahoo.de
Germany
 
NCT01774513
1212013
No
Technische Universität München
Technische Universität München
Not Provided
Not Provided
Technische Universität München
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP