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

Endoscopic Ultrasound Fine Needle Biopsy of Submucosal Lesions of the GI Tract; Finding the Right Needle - A Randomized Study

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.

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