A Clinical Trial With A New Needle Device Comparing Two Needles For EUS_FNA Of Solid Lesions.

Study Overview

A Clinical Trial With a New Needle Device Comparing Two Needles for EUS_FNA of Solid Lesions.

Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe, and effective technique for obtaining samples from the GI wall lesions and from organs adjacent to the GI tract (pancreas, nodes...).Needles available for EUS-FNA include 25G, 22G and 19G. Some studies have suggested that the 25G needle could be equal or even better than the 22G needle. The BXN system and neddles are is a newly developed for EUS-FNA. This trial is developed for testing the accuracy of the new neddle system for EUS-FNA and for comparing the two needles types, 25G and 22G.

N/A

Pancreatic Cancer
Neuroendocrine Tumors
Lymphadenopathies
GIST
Gastric Wall Tumor

DEVICE: 25G needle
DEVICE: 22G needle

BNX-1

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-09-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-09-18
First Submitted that Met QC Criteria 2014-09-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-09-22
First Posted (ESTIMATED) 2014-09-22	Results First Posted N/A	Last Verified 2014-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 25G needle All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).	DEVICE: 25G needle All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).
EXPERIMENTAL: 22G needle All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).	DEVICE: 22G needle All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 25G needle

All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).

DEVICE: 25G needle

All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).

EXPERIMENTAL: 22G needle

All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).

DEVICE: 22G needle

All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).

Primary Outcome Measures	Measure Description	Time Frame
Clinical performance of 22G and 25G needles	Evaluation of whether enough material for adequate cytological/histological analysis can obtained with equal efficacy with the 25G and the 22G needles. The percentages of adequate samples obtained.	18 months

Secondary Outcome Measures	Measure Description	Time Frame
Ease of needle pass	The subjective evaluation of the operator (easy or hard)	18 months
Needle malfunction	Needles do not come out of the cover; kinking; needles do not puncture the tissue (presence or absence of malfunction, and registering of the specific malfunction)	18 months
Number of passes	The total number of passes needed to obtain adequate material for each lesion (absolute number).	18 months
Number of crossovers	The times when the need for passage from the 22G to the 25G needle, or vice versa, registered as percentages of the total procedures.	18 months
Major complications	Bleeding (minor: visible at EUS but without clinical significance or less than 2 g/dl; major: dropping of more than 2 g/dl in Hb levels and clinically significant), perforation (presence/absence), infection (need for hospitalization).	18 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Silvia Carrara, MD

Phone Number: +390282247288

Email: silvia.carrara@humanitas.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

endosonographic appearance of a solid lesions
age >18 years
informed consent.

alteration of the coagulation (INR >1.5, PLT <50 x 103 /µL)
inability to express consent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Silvia Carrara, MD, Humanitas Research Hospital IRCCS, Rozzano-Milan

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Camellini L, Carlinfante G, Azzolini F, Iori V, Cavina M, Sereni G, Decembrino F, Gallo C, Tamagnini I, Valli R, Piana S, Campari C, Gardini G, Sassatelli R. A randomized clinical trial comparing 22G and 25G needles in endoscopic ultrasound-guided fine-needle aspiration of solid lesions. Endoscopy. 2011 Aug;43(8):709-15. doi: 10.1055/s-0030-1256482. Epub 2011 May 24.
Siddiqui UD, Rossi F, Rosenthal LS, Padda MS, Murali-Dharan V, Aslanian HR. EUS-guided FNA of solid pancreatic masses: a prospective, randomized trial comparing 22-gauge and 25-gauge needles. Gastrointest Endosc. 2009 Dec;70(6):1093-7. doi: 10.1016/j.gie.2009.05.037. Epub 2009 Jul 28.

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Clinical Trial Record