Endoscopic Ultrasound (EUS) Fine Needle Biopsy (FNB) Submucosal Nodule

Duke University

Overview

The purpose of this study is to compare the diagnostic accuracy of a novel endoscopic ultrasound (EUS) biopsy needle to the current standard EUS needle. The investigators hypothesize that with the SharkcoreTM needle a diagnostic yield of 90% is possible for subepithelial lesions (SEL) within the Gastrointestinal (GI) tract versus 60% yield with the current needle.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Conditions

GI Lesions

Interventions

Pro Core NeedleDEVICE

Needle will be used in standard fashion utilizing a slow pull technique by an expert endoscopist who is familiar with EUS and use of both needles.

medtronic Sharkcore NeedleDEVICE

Needle will be used in standard fashion utilizing a slow pull technique by an expert endoscopist who is familiar with EUS and use of both needles.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients age 18 or older referred for EUS found to have a hypoechoic lesion \> 8 mm within the GI lumen arising from the muscularis propria, as determined by EUS. * Women that have a negative pregnant test Exclusion Criteria: * Patients under the age of 18. * Uncorrectable coagulopathy (INR\>1.5) * Uncorrectable thrombocytopenia (platelet count \<50,000) * Patient who is unable to comply with study requirements * Pregnant women * Female patients who are not tested per our current unit protocol * Refusal to consent or unable to provide informed consent

Locations (1)

Duke

Durham, North Carolina, United States

Outcomes

Primary Outcomes

diagnostic accuracy of biopsy needle

Time frame: end of biopsy, approximately 10 minutes

Data from ClinicalTrials.gov

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