MedTrace Logo

Comparative Study of 22 and 25 Gauge ProCore EUS-guided Biopsy in Pancreatic Mass

NCT01727921 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2016-04-28

No results posted yet for this study

Summary

Background:

EUS-guided fine needle aspiration (FNA) is a major diagnostic tool in the patient with pancreatic mass with high specificity, specificity and accuracy. However FNA with small needle has sometimes failed in acquisition of tissue due to small caliber. To overcome this limitation, newly designed ProCore needle was developed and flexible 22 and 25 gauge ProCore needles were frequently used. However there was no comparative study of the efficacy and accuracy between 22 and 25 gauge ProCore needle yet.

Aim:

To compare the efficacy and accuracy of EUS-guided FNA between 22 and 25 gauge ProCore needle. (The investigators hypothesized that the accuracy of 25 gauge Procore needle is not inferior to 22 gauge ProCore needle.)

Conditions

  • Pancreatic Neoplasms

Interventions

DEVICE

22 gauge ProCore needle biopsy

22 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle

DEVICE

25 gauge ProCore needle biopsy

25 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Kwanghyuck Lee, MD · Assistant Professor of Medicine, Division of Gastroenterology, Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-12-31
Completion
2015-11-30

Countries

  • South Korea

Study Locations

More Related Trials

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 NCT01727921 on ClinicalTrials.gov