Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle
Completed · Not applicable
Conditions studied: Pancreatic Cancer, Lymphadenopathy, Gastrointestinal Stromal Tumor
In brief
Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. More recently, a needle that allows a tissue biopsy for histologic analysis has been FDA approved. The Echotip Procore (Cook Medical) core biopsy needle (ETP), has been demonstrated to provide excellent efficacy for core biopsy samples. Final diagnostic yield using this needle ranges from 80-90% and appears to be significantly greater than EUS-FNA for lesions requiring histology for diagnosis. However, there is currently only limited data from prospective studies comparing EUS-FNA to EUS-FNB with the ETP needle. The investigators propose a randomized, prospective, cross-over study comparing diagnostic accuracy of EUS-FNA to EUS-FNB.
Key facts
- Study ID
- NCT01769248
- Run by
- Northwestern University
- People needed
- 140
- Starts
- 2012-09-01
- Expected to finish
- 2014-02-01
- Last updated by the study team
- 2018-01-18
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 3.1.1 All patients referred for EUS tissue sampling who provide informed consent
You may not qualify if…
- 3.2.1 Coagulopathy which is not corrected
- 2.2 Diagnostic EUS determines lesion is not amenable to FNA or FNB
Where it is running
- UCLA Medical Center — Los Angeles, California, United States
- California Pacific Medical Center — San Francisco, California, United States
- Moffit Cancer Center — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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