N/A
Completed N=140
Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle
Pancreatic Cancer · Lymphadenopathy · gastrointestinal stromal tumor
Source: ClinicalTrials.gov NCT01769248 ↗
Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcomePrimary: Diagnostic Yield of EUS-FNB and EUS-FNA — 67.1; 90 percentage of patients
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Yield of EUS-FNB and EUS-FNA |
67.1; 90 | — |
| SECONDARY Specimen Adequacy as Assessed by Rapid-onsite Evaluation of FNA and FNB |
60.0; 82.8 | — |
| SECONDARY Percentage of Patients in Whom a Diagnosis is Achieved After Crossover (%) |
96.4; 41.7 | — |
Eligibility Criteria
Inclusion Criteria
- 3.1.1 All patients referred for EUS tissue sampling who provide informed consent
Exclusion Criteria
- 3.2.1 Coagulopathy which is not corrected
3.2.2 Diagnostic EUS determines lesion is not amenable to FNA or FNB
Data sourced from ClinicalTrials.gov (NCT01769248). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.