Comparing Methods to Biopsy Pancreas Mass

NCT ID: NCT01663493

Last Updated: 2017-02-14

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

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-02-28

Brief Summary

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This study will examine whether there is any difference in number of passes needed to diagnose pancreatic masses during endoscopic ultrasound-guided biopsies using 2 different types of needles.

Detailed Description

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Conditions

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Pancreas Mass Diagnosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Fine needle aspiration needle

standard Beacon FNA needle

Group Type OTHER

FNB

Intervention Type PROCEDURE

fine needle biopsy needle

SharkCore fine needle biopsy needle

Group Type OTHER

FNB

Intervention Type PROCEDURE

Interventions

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FNB

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* adult
* pancreas mass

Exclusion Criteria

* coagulopathy
* mass not approachable by endoscopic ultrasound biopsy
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Linda S. Lee

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Linda S Lee

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2012-P-000955/1

Identifier Type: -

Identifier Source: org_study_id

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