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EUS-FNA With 22G Procore Needles vs 22G Conventional Needles

NCT01581762 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2016-10-12

No results posted yet for this study

Summary

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is an important investigation tool to obtain tissue for diagnosis. Nowadays, the performance of EUS-FNA varies with accuracy rates ranging from 60% - 100%. Needles with different diameters have been explored to retrieve tissue specimens. The diagnostic yields, successful rates and safety profiles are similar. It has been suggested that although thinner needles provide less cellular material than do larger needles, the specimens from the former are less contaminated by blood, and thus easier to interpret. In addition, thinner needles may be easier to use because of greater flexibility, particularly for locations requiring important scope bending. As a result, a new 22G FNA needle has been designed in order to improve the tissue-sampling rate (ECHO-HD-22-C, Cook Endoscopy, USA). There is a reverse bevel at the tip of the new needle with promotes collection of core sample by shearing material from target lesion during retrograde movement of the needle in the lesion. The feasibility and safety of this newly design EUS-FNA needle have been demonstrated in a recent multicenter, pooled, cohort study using the 19G version. Successful puncture was technically feasible in 98.2% of cases and the overall accuracy of 92.9%. There were no complications related to the technique.

The aim of this study is to compare the tissue-sampling rate and the diagnostic accuracy rate of EUS-FNA between the uses of the convention and newly designed 22-gauge needles.

Conditions

  • Self Efficacy

Interventions

PROCEDURE

EUS-guided FNA

EUS-guided FNA with two types of needles - conventional 22G needle (Sham control) and Procore needle (active comparator)

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • CHARING C CHONG, MBChB · Department of Surgery, CUHK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Hong Kong

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 NCT01581762 on ClinicalTrials.gov