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

Sponsor

Istituto Clinico Humanitas (Other)

Overall Status

Unknown status

CT.gov ID

NCT02246322

Collaborator

(none)

144

Enrollment

Location

Arms

Duration (Months)

9.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Neuroendocrine Tumors Lymphadenopathies GIST Gastric Wall Tumor	Device: 25G needle Device: 22G needle	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

A Randomized Clinical Trial With a New Needle Device Comparing 25G and 22G Needle in Endoscopic Ultrasound Fine-needle Aspiration of Solid Lesions.

Study Start Date :

Aug 1, 2013

Anticipated Primary Completion Date :

Oct 1, 2014

Anticipated Study Completion Date :

Nov 1, 2014

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Clinical performance of 22G and 25G needles [18 months]
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.

Secondary Outcome Measures

Ease of needle pass [18 months]
The subjective evaluation of the operator (easy or hard)
Needle malfunction [18 months]
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)
Number of passes [18 months]
The total number of passes needed to obtain adequate material for each lesion (absolute number).
Number of crossovers [18 months]
The times when the need for passage from the 22G to the 25G needle, or vice versa, registered as percentages of the total procedures.
Major complications [18 months]
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).