Endoscopic Ultrasound (EUS) Fine Needle Biopsy (FNB) Submucosal Nodule
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/24/2018 |
| Start Date: | September 5, 2017 |
| End Date: | September 2019 |
| Contact: | Tina Lucas |
| Email: | tina.lucas@duke.edu |
| Phone: | 919 668 1679 |
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.
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
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