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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pancreatic Cancer, Neuroendocrine Tumors, Lymphadenopathies, GIST, Gastric Wall Tumor

Intervention / Treatment
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* Device: 25G needle
* Device: 22G needle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 25G needle<br>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<br>* 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).<br>|
| Experimental: 22G needle<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance of 22G and 25G needles | 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. | 18 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic cancer, Neuroendocrine tumors, Lymphadenopathies, GIST, Gastrointestinal wall neoplasia