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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Cancer; Neuroendocrine Tumors; GIST; Lymphadenopathies; Gastric Wall Tumor
• Intervention / Treatment: Device: 25G needle; Device: 22G needle

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Silvia Carrara, MD; Phone Number: +390282247288; Email: silvia.carrara@humanitas.it

Study Locations

• Italy
  • Rozzano, Milan, Italy, 20089
    • Recruiting
    • Humanitas Research Hospital
    • Principal Investigator: Silvia Carrara, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: 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).
Experimental: 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).	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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Investigators: Principal Investigator: Silvia Carrara, MD, Humanitas Research Hospital

Publications and helpful links

General Publications

• Camellini L, Carlinfante G, Azzolini F, Iori V, Cavina M, Sereni G, Decembrino F, Gallo C, Tamagnini I, Valli R, Piana S, Campari C, Gardini G, Sassatelli R. A randomized clinical trial comparing 22G and 25G needles in endoscopic ultrasound-guided fine-needle aspiration of solid lesions. Endoscopy. 2011 Aug;43(8):709-15. doi: 10.1055/s-0030-1256482. Epub 2011 May 24.
• Siddiqui UD, Rossi F, Rosenthal LS, Padda MS, Murali-Dharan V, Aslanian HR. EUS-guided FNA of solid pancreatic masses: a prospective, randomized trial comparing 22-gauge and 25-gauge needles. Gastrointest Endosc. 2009 Dec;70(6):1093-7. doi: 10.1016/j.gie.2009.05.037. Epub 2009 Jul 28.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): October 1, 2014
• Study Completion (Anticipated): November 1, 2014

Study Registration Dates

• First Submitted: September 1, 2014
• First Submitted That Met QC Criteria: September 18, 2014
• First Posted (Estimate): September 22, 2014

Study Record Updates

• Last Update Posted (Estimate): September 22, 2014
• Last Update Submitted That Met QC Criteria: September 18, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Pancreatic cancer; Neuroendocrine tumors; GIST; Lymphadenopathies; Gastrointestinal wall neoplasia
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Pancreatic Diseases; Pancreatic Neoplasms; Neuroendocrine Tumors; Lymphadenopathy
• Other Study ID Numbers: BNX-1