Prospective Evaluation of the Diagnostic Efficacy of a EUS Guided FNB Needle (AQUIRE®) in Tumors of the Pancreas, Submucosal Tumors and Lymph Node Disease of the Upper GI Tract
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tumors of the Pancreas
- Sponsor
- Philipps University Marburg Medical Center
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- tissue yield
- Last Updated
- 7 years ago
Overview
Brief Summary
The present study investigates the efficacy of a new Endoultrasound guided fine needle biopsy (EUS-FNB) device (AquireTM Boston Scientific= AQUIRE®) for obtaining histological tissue cylinders in the diagnosis of solid pancreatic tumors, submucosal tumors of the upper gastrointestinal tract (esophagus, stomach, duodenum) and lymph node disease..
Detailed Description
The AquireTM FNB device uses a triple point tip that is designed to maximize tissue capture and minimize fragmentation. The efficiency of the 22 Gauge needle is evaluated in a prospective single arm study. The material obtained will be collected for formalin fixation and analyzed by a pathologist blinded for the type of needle device.
Investigators
Ulrike Denzer
Prof. Dr. med. Ulrike Denzer, Head of the department of endoscopy
Philipps University Marburg Medical Center
Eligibility Criteria
Inclusion Criteria
- •Informed consent
- •Indication for EUS FNB with solid pancreatic tumors, submucosal tumors or lymph node disease of the upper gastrointestinal tract will be included
Exclusion Criteria
- •Cystic pancreatic tumors
- •Contraindication for EUS FNB
- •Lesion of interest cannot be reached endosonographically
Outcomes
Primary Outcomes
tissue yield
Time Frame: 12 month after FNB
The primary outcome of the present study is to analyze the percentage in which a representative histological sample can be obtained by EUS-FNB (quality score 3 as defined by Payne et al.).