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

NCT ID: NCT02920944

Last Updated: 2017-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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EUS-FNB with 20-gauge

EUS-FNB with 20-gauge procore needle

Group Type EXPERIMENTAL

EUS-FNB with 20 gauge ProCore needle

Intervention Type DEVICE

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

EUS-FNB with 22-gauge

EUS-FNB with 22-gauge procore needle

Group Type ACTIVE_COMPARATOR

EUS-FNB with 22 gauge ProCore needle

Intervention Type DEVICE

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

Interventions

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EUS-FNB with 20 gauge ProCore needle

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

Intervention Type DEVICE

EUS-FNB with 22 gauge ProCore needle

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul St. Mary's Hospital

OTHER

Sponsor Role collaborator

Seung Bae Yoon

OTHER

Sponsor Role lead

Responsible Party

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Seung Bae Yoon

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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In Seok Lee, MD

Role: STUDY_DIRECTOR

The Catholic University of Korea

Locations

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The Catholic University of Korea

Seoul, No State, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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EUS 20 gauge

Identifier Type: -

Identifier Source: org_study_id