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Study Comparing 25d ProCor Needle Versus the Standard 25g Needle for Biopsies Performed by EUS-FNA

NCT02048124 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2020-11-10

No results posted yet for this study

Summary

Background: There is an ongoing interest in developing Endoscopic Ultrasound /Fine Needle Aspiration (EUS-FNA) needles that can provide tissue core biopsies for a true histological (rather than cytological) evaluation. By slightly modifying the traditional EUS-FNA needle, a new needle named "ProCor" was developed in the hope of obtaining core samples and thus increase diagnostic yield.

Objective: In this research project, we propose to conduct a prospective trial to compare the results obtained with two types of needles: a 25g standard needle (25gS) and the 25g ProCor needle (25gP).

EUS-FNA Biopsies will be obtained with both the 25S and 25P needles in each lesion; a randomisation sequence will set in order to determine which of the two needles will first be used (25S or 25P).

The cytological or histological diagnoses will be made; . for histological diagnosis, the pathologist will first establish the presence or absence of a tissue core (defined as a measurable cylinder of tissue). The pathologist will assess the adequacy of each specimen: cellularity (score 1 "poor"; score 2 "good"; score 3 "excellent"),\[14\] sample bloodiness (score 1 "minimal";score 2 "moderate"; score 3 "significant", and the presence or absence of malignancy("positive" / "negative" / "suspicious" / inconclusive).

Results for continuous variables will be summarized using mean ± SD, . and categorical variables using proportions. The 25S and 25P groups will be compared using Chi-square test for categorical variables and, Student t test for continuous variablesTwo-sided p values less than 0.05 will be considered statistically significant. Data will be analyzed using SPSS v 15.0 (SPSS Inc., Chicago IL) statistical software.

Conditions

  • Solid Lesion Biopsies

Interventions

DEVICE

25g standard needle

DEVICE

25d ProCor needle

Sponsors & Collaborators

  • 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
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-01
Primary Completion
2018-06-30
Completion
2020-09-15

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 NCT02048124 on ClinicalTrials.gov