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

• Conditions: Submucosal Tumor of Gastrointestinal Tract (Disorder); Lymph Node Disease; Tumors of the Pancreas
• Interventions: Device: Endoultrasound guided FNB

• Registration Number: NCT03621852
• Lead Sponsor: Philipps University Marburg Medical Center

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.

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2018-07-24
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-08
• Last Update Submitted: 2018-08-08
• Study First Posted: 2018-08-09
• Last Update Posted: 2018-08-09
• Primary Completion: 2019-07-01
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.).

Trial Locations

Locations (1)

Universitätskliniken Gießen und Marburg, Standort Marburg; 🇩🇪 Marburg, Hessen, Germany