NCT02246322

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer
• Neuroendocrine Tumors
• Lymphadenopathies
• GIST
• Gastric Wall Tumor

Interventions

Type	Name	Description
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).
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).

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-10-01
• Completion: 2014-11-01
• First posted: 2014-09-22
• Last updated: 2014-09-22

Locations

1 site across 1 country: Italy