Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Blood and Lymph Conditions

Rare Diseases

Pancreatic Neoplasms

Neuroendocrine Tumors

Lymphadenopathy

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Lymphatic Diseases

Pancreatic Cancer

Neuroendocrine Tumor

Neuroepithelioma

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

22G needle

Silvia Carrara, MD

Alessandro Repici, MD

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.

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.

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.

The subjective evaluation of the operator (easy or hard)

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)

The total number of passes needed to obtain adequate material for each lesion (absolute number).

The times when the need for passage from the 22G to the 25G needle, or vice versa, registered as percentages of the total procedures.

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).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Clinical Trial With a New Needle Device Comparing Two Needles for EUS_FNA of Solid Lesions.	NCT02246322	Pancreatic Canc... Neuroendocrine ... Lymphadenopathi... GIST Gastric Wall Tu...	25G needle 22G needle	18 Years -	Istituto Clinico Humanitas
A Clinical Trial With a New Needle Device Comparing Two Needles for EUS_FNA of Solid Lesions.	NCT02246322	Pancreatic Canc... Neuroendocrine ... Lymphadenopathi... GIST Gastric Wall Tu...	25G needle 22G needle	18 Years -	Istituto Clinico Humanitas

Spots Global Cancer Trial Database for gastrointestinal wall neoplasia