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

Pancreatic Cancer Clinical Trial

— EUS-FNA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02246322
• Other study ID #: BNX-1
• Status: Recruiting
• Phase: N/A
• First received: September 1, 2014
• Last updated: September 18, 2014
• Start date: August 2013
• Est. completion date: November 2014

Study information

• Verified date: September 2014
• Source: Istituto Clinico Humanitas
• Contact: Silvia Carrara, MD
• Phone: +390282247288
• Email: silvia.carrara[@]humanitas.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

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

Intervention

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).
• 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).

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano, Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Ease of needle pass	The subjective evaluation of the operator (easy or hard)	18 months	Yes
Secondary	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	Yes
Secondary	Number of passes	The total number of passes needed to obtain adequate material for each lesion (absolute number).	18 months	Yes
Secondary	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	Yes
Secondary	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	Yes