N/A
N=56
Core Biopsy Endo Sonography Study Evaluation of the Significance of the Pro-core® Needle
Pancreatic Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT02181140 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcome: Primary: Diagnostic Accuracy — 84 Diagnostic accuracy (%)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EUS guided FNA and fine needle punction (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Accuracy |
84 | — |
| SECONDARY EUS Pro Core FNA: Histology Samples |
36 | — |
| SECONDARY Complication Rates |
— | — |
Summary
The study is designed to evaluate the diagnostic accuracy of a new designed endoscopic ultrasonography (EUS) Core biopsy aspiration needle in comparison to a conventional EUS aspiration needle in GI-tumors.
Eligibility Criteria
Inclusion Criteria
- clinical indication for endoscopic ultrasound diagnostics with fine needle biopsies
- age greater than 18 years
Exclusion Criteria
- difficult or impossible approach to desired structures due to anatomy (postoperative anatomy, e.g.)
- cystic lesion, e.g. cystic pancreas tumors
- coagulopathy
- severe general condition of the patient
- other contraindications for endoscopical ultrasound aided fine needle punction
Data sourced from ClinicalTrials.gov (NCT02181140). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.