Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Cancer, Neurology, Endocrine, Pancreatic Cancer |
| Therapuetic Areas: | Endocrinology, Neurology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 1/20/2018 |
| Start Date: | September 2012 |
| End Date: | February 2014 |
Randomized Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle
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.
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.
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.
We will compare tissue samples obtained by standard FNA to FNB with a sample size of 140
patients with the primary outcome being diagnostic yield. Each patient will be randomized to
FNA or FNA. If after 3 passes the on-site evaluation remains inadequate, the endoscopist will
crossover to the other arm.
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.
We will compare tissue samples obtained by standard FNA to FNB with a sample size of 140
patients with the primary outcome being diagnostic yield. Each patient will be randomized to
FNA or FNA. If after 3 passes the on-site evaluation remains inadequate, the endoscopist will
crossover to the other arm.
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
We found this trial at
3
sites
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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