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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
January 22, 2013
January 24, 2013
January 24, 2013
January 2013
December 2014   (Final data collection date for primary outcome measure)
diagnostic yield [ Time Frame: 6 months ]
Number of patients with adequate tissue sample (which allows definitive diagnosis)
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Intervention Model: Single Group Assignment
Masking: None (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.
 
Unknown status
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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01774513
1212013
No
Not Provided
Not Provided
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