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Procedure

Slow Pass First - Fast Pass Second for Pancreatic Cancer (SMARTEUS Trial)

N/A
Waitlist Available
Led By Mihai Ciocirlan, MS, PhD
Research Sponsored by Carol Davila University of Medicine and Pharmacy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
No Placebo-Only Group

Summary

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).

Eligible Conditions
  • Pancreatic Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cytological diagnostic accuracy of EUS FNA, for "fast" and "slow" passages
Tissue acquisition rate of EUS FNA
Secondary study objectives
Cellularity score of EUS FNA
Quality of cytological specimen of EUS FNA
The linear relationship between needle acceleration and outcomes 1,2,3 and 4
Other study objectives
Subgroup analysis for trans-gastric and trans-duodenal route

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
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 "fast" pass first, "slow" pass second.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EUS FNA
2017
N/A
~120

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Who is running the clinical trial?

Carol Davila University of Medicine and PharmacyLead Sponsor
35 Previous Clinical Trials
5,107 Total Patients Enrolled
Mihai Ciocirlan, MS, PhDPrincipal Investigator"Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania
~8 spots leftby Nov 2025