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

Istituto Clinico Humanitas

Status: Unknown

Conditions: Gastric Wall Tumor; Neuroendocrine Tumors; GIST; Pancreatic Cancer; Lymphadenopathies

Treatments: Device: 22G needle; Device: 25G needle

Study type: Interventional

Funder types: Other

Identifiers

NCT02246322

BNX-1

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

25G needle

Experimental group

Description:

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).

Treatment:

Device: 25G needle

22G needle

Experimental group

Description:

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).

Treatment:

Device: 22G needle