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Endoscopic Ultrasonography (EUS) Guided Fine Needle Aspiration Using Free Stylet 22g and 25 g Needles

NCT01543282 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-05-22

No results posted yet for this study

Summary

This is a randomized controlled study comparing EUS-FNA with 22 gauge and 25 gauge needles in consecutive patients.

Summary

Background: three needle sizes for endoscopic ultrasonography guided fine needle aspiration (EUS-FNA) are currently available: 22 Gauge (G), 25 G and 19 G. However, well design studies comparing them regarding efficacy and feasibility are lacking.

Aims: to investigate diagnostic yield, specimen adequacy, feasibility and complications of the conventional 22 G compared with the 25 G needle.

Methods: patients ≥ 18 years, referred to EUS-FNA for a solid lesion will be considered for inclusion. Patients with suspected diagnosis of lymphoma, GIST, sarcoidosis, significant coagulopathy (APT \< 50% or platelets \< 50000/mm3), use of warfarin or other anticoagulants, use of clopidogrel within 7 days of EUS, inability or refusal to sign the informed consent and pregnancy or suspected pregnancy will be excluded.

Participants will be randomized to 22 G needle and 25 G FNA. Chi-square test will be used to compare proportions. Continuous variables will be compared using Student´s t test. A two-tailed P values of less than 0.05 will be considered statistically significant. The diagnostic yield of 25 G and 22 G needle will be evaluated by four criteria: sensitivity, specificity, positive predictive value and negative predictive value. An expected rate of 85% diagnostic yield from EUS guided FNA by using 22G needle will be considered. By using a power of 80% and an α value of 0.05 would be necessary 120 patients per group to detect a 15% difference in the rate of diagnostic yield.

Conditions

  • Solid Neoplasms

Interventions

DEVICE

Endosonography guided fine needle aspiration cytology ( Cook Medical, Boston Scientific)

Patients will be randomized either to receive EUS-FNA with a 22 g needle or 25 g needle. EUS-FNA passes will be performed without stylet until sample adequacy or until a maximum of 5 FNA passes in pancreatic lesions or 3 FNA passes in other lesions. In case of inadequate sample after 3 passes, or needle failure, cross over to the other type of needle is allowed.

Sponsors & Collaborators

  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal

    collaborator OTHER

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Anand V Sahai, MD · Hopital Saint Luc (Centre Hopitalier de l´Université du Montreal) Montreal, Quebec, Canada

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-10
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01543282 on ClinicalTrials.gov