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

Not Applicable

• Conditions: Neuroendocrine Tumors; Lymphadenopathies; Gastric Wall Tumor; Pancreatic Cancer; GIST
• Interventions: Device: 22G needle; Device: 25G needle

• Registration Number: NCT02246322
• Lead Sponsor: Istituto Clinico Humanitas

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Status Verified: 2014-09
• Study First Submitted: 2014-09-01
• Study First Submitted QC: 2014-09-18
• Last Update Submitted: 2014-09-18
• Study First Posted: 2014-09-22
• Last Update Posted: 2014-09-22
• Primary Completion: 2014-10
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
22G needle	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).
25G needle	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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)
Ease of needle pass	18 months	The subjective evaluation of the operator (easy or hard)
Number of passes	18 months	The total number of passes needed to obtain adequate material for each lesion (absolute number).

Trial Locations

Locations (1)

Humanitas Research Hospital; 🇮🇹 Rozzano, Milan, Italy