Prospective Evaluation of the Diagnostic Efficacy of a EUS Guided FNB Needle (AQUIRE®)

Philipps University

Status: Unknown

Conditions: Lymph Node Disease; Submucosal Tumor of Gastrointestinal Tract (Disorder); Tumors of the Pancreas

Treatments: Device: Endoultrasound guided FNB

Study type: Observational

Funder types: Other

Identifiers

NCT03621852

VERSION 2 04/2017

Details and patient eligibility

About

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..

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

Endoultrasound guided FNB

Description:

Patients with tumors of the pancreas, submucosal tumors or lymphnode disease of the upper gastrointestinal tract, which have to undergo EUS guided FNB.

Treatment:

Device: Endoultrasound guided FNB