EUS-guided Procore-biopsy in Diagnosing Autoimmune Pancreatitis
Sponsor
Technische Universität München (Other)
Overall Status
Unknown status
CT.gov ID
NCT01774513
Collaborator
(none)
16
1
1
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Study Start Date
:
Jan 1, 2013
Anticipated Primary Completion Date
:
Dec 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Procore Needle
|
Device: Procore-Needle
|
Outcome Measures
Primary Outcome Measures
- diagnostic yield [6 months]
Number of patients with adequate tissue sample (which allows definitive diagnosis)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Klinikum rechts der Isar | Munich | Bavaria | Germany | 81675 |
Sponsors and Collaborators
- Technische Universität München
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01774513
Other Study ID Numbers:
- 1212013
First Posted:
Jan 24, 2013
Last Update Posted:
Jan 24, 2013
Last Verified:
Jan 1, 2013