- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01774513
EUS-guided Procore-biopsy in Diagnosing Autoimmune Pancreatitis
January 22, 2013 updated by: Technical University of Munich
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
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stefan von Delius, MD
- Email: stefan_ruckert@yahoo.de
Study Locations
-
-
Bavaria
-
Munich, Bavaria, Germany, 81675
- Recruiting
- Klinikum Rechts der Isar
-
Contact:
- Stefan von Delius, MD
- Email: stefan_ruckert@yahoo.de
-
Sub-Investigator:
- Christoph Schlag, MD
-
Sub-Investigator:
- Gregor Weirich, MD
-
Sub-Investigator:
- Hana Algül, MD
-
Sub-Investigator:
- Christiane Schwerdtfeger, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Procore Needle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
diagnostic yield
Time Frame: 6 months
|
Number of patients with adequate tissue sample (which allows definitive diagnosis)
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
January 22, 2013
First Submitted That Met QC Criteria
January 22, 2013
First Posted (Estimate)
January 24, 2013
Study Record Updates
Last Update Posted (Estimate)
January 24, 2013
Last Update Submitted That Met QC Criteria
January 22, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1212013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Bin ChengCompleted
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Clinical Trials on Procore-Needle
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Samsung Medical CenterCompletedPancreatic NeoplasmsKorea, Republic of
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Postgraduate Institute of Medical Education and...Completed
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Huazhong University of Science and TechnologyUnknownLymphatic Metastasis | Pancreas Neoplasms | Neoplasm Metastases | Unknown Primary Neoplasm MetastasisChina
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Johns Hopkins UniversityWithdrawnLymphoma | Solid Tumors | Autoimmune Pancreatitis | Mesenchymal TumorUnited States
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Seung Bae YoonSeoul St. Mary's HospitalCompletedPancreatic NeoplasmsKorea, Republic of
-
Yonsei UniversityCompletedPancreatic Cancer | Solid Pancreatic and Peripancreatic LesionKorea, Republic of
-
Medical University of South CarolinaJohns Hopkins University; University of North Carolina; Cook Endoscopy; Thoraxklinik-Heidelberg...CompletedQuantity of Tissue Obtained | Quality of Tissue Obtained | Ease of Use of 22-gauge ProCore EBUS Needles and the Standard 22-gauge NeedlesUnited States
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Technical University of MunichUnknownSubepithelial Tumors of the Upper Gastrointestinal TractGermany
-
Samsung Medical CenterOlympusCompletedPancreatic CancerKorea, Republic of
-
Milton S. Hershey Medical CenterWithdrawn