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

Lymph Node Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03621852
• Other study ID #: VERSION 2 04/2017
• Status: Recruiting
• Start date: July 1, 2017
• Est. completion date: July 1, 2020

Study information

• Verified date: August 2018
• Source: Philipps University Marburg Medical Center
• Contact: Ulrike Denzer, PD. Dr. med.
• Phone: 004964215866460
• Email: uwdenzer[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Lymph Node Disease
• Lymphadenopathy
• Neoplasms
• Pancreatic Neoplasms
• Submucosal Tumor of Gastrointestinal Tract (Disorder)
• Tumors of the Pancreas

Intervention

Device:
• Endoultrasound guided FNB
EUS FNB with Aquire TM device

Locations

Country	Name	City	State
Germany	Universitätskliniken Gießen und Marburg, Standort Marburg	Marburg	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tissue yield	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.).	12 month after FNB