Diagnostic Yield Of 20-gauge Procore Needle For EUS-guided FNA Biopsy In Solid Pancreatic Lesions

Study Overview

Diagnostic Yield of 20-gauge Procore Needle for EUS-guided FNA Biopsy in Solid Pancreatic Lesions

This study aims to examine technical feasibility and diagnostic yield of new 20-gauge Procore needle for EUS-guided fine needle biopsy in solid lesions by comparing with 22-gauge Procore needle. The study design is prospective, randomized study.

N/A

Pancreatic Neoplasms

DEVICE: EUS-FNB with 20 gauge ProCore needle
DEVICE: EUS-FNB with 22 gauge ProCore needle

EUS 20 gauge

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-09-28	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-10-02
First Submitted that Met QC Criteria 2016-09-28	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-10-03
First Posted (ACTUAL) 2016-09-30	Results First Posted N/A	Last Verified 2017-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Single

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: EUS-FNB with 20-gauge EUS-FNB with 20-gauge procore needle	DEVICE: EUS-FNB with 20 gauge ProCore needle EUS-FNB with 20-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)
ACTIVE_COMPARATOR: EUS-FNB with 22-gauge EUS-FNB with 22-gauge procore needle	DEVICE: EUS-FNB with 22 gauge ProCore needle EUS-FNB with 22-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: EUS-FNB with 20-gauge

EUS-FNB with 20-gauge procore needle

DEVICE: EUS-FNB with 20 gauge ProCore needle

EUS-FNB with 20-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)

ACTIVE_COMPARATOR: EUS-FNB with 22-gauge

EUS-FNB with 22-gauge procore needle

DEVICE: EUS-FNB with 22 gauge ProCore needle

EUS-FNB with 22-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)

Primary Outcome Measures	Measure Description	Time Frame
single diagnostic yield of the histologic core		up to 5 minutes after endoscopic ultrasound-guided fine needle biopsy

Secondary Outcome Measures	Measure Description	Time Frame
total diagnostic yield of the histologic core		up to 5 minutes after endoscopic ultrasound-guided fine needle biopsy

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

Patients older than 20 years referred to our medical center for EUS-FNB with diagnosed or suspected solid pancreatic masses according to clinical evaluation and imaging studies.

cystic pancreatic lesions, patients haemodynamically unstable or with severe coagulopathy (international normalized ratio [INR] > 1.5 or platelet count < 50,000 cells/cubic millimeter [cmm3]), patients unable to suspend anticoagulant/anti-platelet therapy, pregnancy, inability or refusal to give informed consent, and refusal to participate in the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Seoul St. Mary's Hospital

Investigators

STUDY_DIRECTOR: In Seok Lee, MD, The Catholic University of Korea

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record