NCT03303352: SMARTEUS

Connect Your Needle to Your Phone to Increase EUS FNA Diagnostic Yield?

Completed NA Last updated 31 January 2020

What this trial tests

NA trial testing EUS FNA in Pancreatic Neoplasms in 64 participants. Completed in 30 January 2020.

Timeline

24 July 2017

Primary endpoint
30 January 2020

30 January 2020

Quick facts

Lead sponsor	Carol Davila University of Medicine and Pharmacy
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	diagnostic
Enrollment	64
Start date	24 July 2017
Primary completion	30 January 2020
Estimated completion	30 January 2020
Sites	3 locations across Romania

Drugs / interventions tested

• EUS FNA

Conditions studied

• Pancreatic Neoplasms — all drugs for Pancreatic Neoplasms →

Sponsor

Carol Davila University of Medicine and Pharmacy

Who can join

18 and older, any sex, with Pancreatic Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Summary

Endoscopic ultrasound fine needle aspiration (EUS FNA) is an established and recommended technique for diagnostic of solid pancreatic masses. The accuracy of the technique depends on the operator experience, lesion type and location, type of procedure sedation as well as procedure related technique factors (presence of elastography or contrast enhanced imaging, needle diameter, presence of stylet, use of suction and type of suction, the number and method of "to and fro" movements, the number of passes and the presence of a cytopathologist in the examination room).

The relationship between the "to and fro" movement and the EUS FNA yield in solid pancreatic masses has only been explored in the literature in a subjective fashion, without accurately measuring the needle acceleration.

Recently, a simple electronic sensor device connected by Bluetooth to a phone, has been proposed for teaching and research purposes. Among its sensors, it includes an accelerometer which can measure the instant scalar acceleration of an object and transmit it to the connected phone. By attaching this device to the EUS FNA needle, the investigators can accurately measure the instant scalar acceleration of the "to and fro" movements.

The investigators propose a prospective, multicenter, randomized, crossover study on 51 patients with solid pancreatic masses to compare an EUS FNA "fast" sampling technique in which the needle acceleration is higher than 1 g to a "slow" technique where the needle acceleration is lower than 1g.

The primary objective of the study is to compare the tissue acquisition rates and the histological diagnosis accuracy between the 2 methods "fast" and "slow". The secondary objectives of the study are to compare the cellularity and quality scores of the obtained specimens between the 2 methods. Another secondary objective is to find a linear relationship between the needle acceleration and the EUS FNA yield (histological diagnosis, sample cellularity and adequacy).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. UEG Week 2018 Poster Presentations
   · 2018 · cited 2×