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

NCT03303352 | Completed

• 1 other identifier: SMARTEUS
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (2)

• Tissue acquisition rate of EUS FNA

  Fraction of tissue acquisition from all included patients,for "fast" and "slow" passages

  up to 12 months

• Cytological diagnostic accuracy of EUS FNA, for "fast" and "slow" passages

  Fraction of correct diagnosis from all included patients

  up to 12 months

Secondary Outcomes (3)

• Cellularity score of EUS FNA

  up to 12 months

• Quality of cytological specimen of EUS FNA

  up to 12 months

• The linear relationship between needle acceleration and outcomes 1,2,3 and 4

  up to 12 months

Other Outcomes (1)

• Subgroup analysis for trans-gastric and trans-duodenal route

  up to 12 months

Study Arms (2)

Fast Pass First, Slow Pass Second

EXPERIMENTAL

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.

Procedure: EUS FNA

Slow Pass First - Fast Pass Second

EXPERIMENTAL

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.

Procedure: EUS FNA

Interventions

EUS FNA PROCEDURE

Patients with solid pancreatic masses fulfilling the inclusion and exclusion criteria will be randomly allocated to receive EUS FNA (endoscopic ultrasound fine needle aspiration).

Fast Pass First, Slow Pass Second; Slow Pass First - Fast Pass Second

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• a solid pancreatic mass with a diameter less than 20mm or with known histology;
• a cystic pancreatic mass, without a solid component;
• coagulation disorder (international normalized ratio above 1.5, activated partial thromboplastin time above 42 seconds, platelet count less than 60000/mmc) or impossibility to stop antiaggregants or anticoagulants according to the European Society of Digestive Endoscopy guidelines;
• European Cooperative Oncology Group status 4;
• American Society of Anesthesiology score higher than 3;
• pregnant women;
• age under 18 years old;
• refusal or impossibility to sign informed consent.

Sponsors & Collaborators

• Carol Davila University of Medicine and Pharmacy: lead

Study Sites (3)

"Prof. Dr. Agrippa Ionescu" Clinical and Emerency Hospital

Bucharest, 0112013, Romania

Location

Floreasca Emergency Hospital

Bucharest, 014471, Romania

Location

Colentina Clinical Hospital

Bucharest, 020125, Romania

Location

Related Publications (1)

• Ciocirlan M, Gheorghiu A, Bilous D, Cruceru M, Manaila G, Tianu E, Vladut C. Monitored needle acceleration in endoscopic ultrasound-guided fine-needle aspiration of solid pancreatic masses improves sample quality and diagnostic accuracy: a randomized trial. Endoscopy. 2022 Apr;54(4):389-393. doi: 10.1055/a-1497-6532. Epub 2021 Jul 1.

  PMID: 33940637 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Mihai Ciocirlan, MS, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: At the end of the study, all slides will be scored for cellularity and quality on a 0 to 3 discrete scale, according to the previous work done by Mukai S et al \[12\], by an independent pathologist, from an institution not involved in the initial histological analysis, blinded to the type of pass ("fast" or "slow").
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Senior Lecturer in Gastroenterology and Hepatology

Model Details: A prospective, multicenter, randomized, crossover study.

Study Record Dates

• First Submitted: September 30, 2017
• First Posted: October 6, 2017
• Study Start: July 24, 2017
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: January 31, 2020

Record last verified: 2020-01

Locations

RO (3)