Connect Your Needle to Your Phone to Increase EUS FNA Diagnostic Yield?
(SMARTEUS Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byMihai Ciocirlan, MS, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Carol Davila University of Medicine and Pharmacy

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Research Team

Mihai Ciocirlan, MS, PhD

Principal Investigator

"Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania

Eligibility Criteria

Inclusion Criteria

a solid pancreatic lesion with diameter larger than 20mm, with or without a cystic component, with unknown histology;

age above 18 years old;

signed informed consent;

Treatment Details

Interventions

EUS FNA (Procedure)

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Slow Pass First - Fast Pass SecondExperimental Treatment1 Intervention

Each patient will receive 2 EUS FNA passes, 1 "fast" and 1 "slow", with a 22 gauge EUS needle, with suction syringe, employing the fanning technique, 10 jabs for each pass. A "fast" pass has an advancing mean acceleration jab ("to" movement) higher than 1 g, while a "slow" pass has an advancing mean acceleration jab of less than 1 g (where 1 g equals 9.8 m/s2). Both movements will have a "slow" "fro" withdrawal movement, from the point of maximum advance into the lesion to the lesion entry site. For each patient, the passes order with be either done as "slow" pass first, "fast" pass second.

Group II: Fast Pass First, Slow Pass SecondExperimental Treatment1 Intervention