Lymph Node Disease, Submucosal Tumor of Gastrointestinal Tract (Disorder), Tumors of the Pancreas
Conditions
Keywords
Endosonography, fine needle biopsy
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.
Interventions
DEVICEEndoultrasound guided FNB
EUS FNB with Aquire TM device
Sponsors
Philipps University Marburg
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tissue yield | 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.). |
Countries
Germany
Contacts
Primary ContactUlrike Denzer, PD. Dr. med.
Backup ContactAlexander Waldthaler, Dr.med.
Outcome results
None listed