Back to resultsEUS-guided Procore-biopsy in Diagnosing Autoimmune Pancreatitis
Primary Purpose
Autoimmune Pancreatitis
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Procore-Needle
Sponsored by
About this trial
This is an interventional diagnostic trial for Autoimmune Pancreatitis
Eligibility 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)
Sites / Locations
- Klinikum rechts der IsarRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Procore Needle
Arm Description
Outcomes
Primary Outcome Measures
diagnostic yield
Number of patients with adequate tissue sample (which allows definitive diagnosis)
Secondary Outcome Measures
Full Information
NCT ID
NCT01774513
First Posted
January 22, 2013
Last Updated
January 22, 2013
Sponsor
Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT01774513
Brief Title
EUS-guided Procore-biopsy in Diagnosing Autoimmune Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Pancreatitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Procore Needle
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Procore-Needle
Primary Outcome Measure Information:
Title
diagnostic yield
Description
Number of patients with adequate tissue sample (which allows definitive diagnosis)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan von Delius, MD
Email
stefan_ruckert@yahoo.de
Facility Information:
Facility Name
Klinikum rechts der Isar
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan von Delius, MD
Email
stefan_ruckert@yahoo.de
First Name & Middle Initial & Last Name & Degree
Stefan von Delius, MD
First Name & Middle Initial & Last Name & Degree
Christoph Schlag, MD
First Name & Middle Initial & Last Name & Degree
Hana Algül, MD
First Name & Middle Initial & Last Name & Degree
Gregor Weirich, MD
First Name & Middle Initial & Last Name & Degree
Christiane Schwerdtfeger, MD
12. IPD Sharing Statement
Learn more about this trial
EUS-guided Procore-biopsy in Diagnosing Autoimmune Pancreatitis
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