Pancreatic Cancer Clinical Trial
— MUCINOfficial title:
Randomized Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle
Verified date | December 2017 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 140 |
Est. completion date | February 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | UCLA Medical Center | Los Angeles | California |
United States | California Pacific Medical Center | San Francisco | California |
United States | Moffit Cancer Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Northwestern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic Yield of EUS-FNB and EUS-FNA | The investigators' primary outcome measure will assess the diagnostic yield (percentage of patients with a diagnosis) of EUS-FNB (fine-needle biopsy) to provide a final diagnosis of the lesion being sampled. This will be expressed as a percentage. | 1 year | |
Secondary | Specimen Adequacy as Assessed by Rapid-onsite Evaluation of FNA and FNB | The investigators' secondary outcome will assess the ability to obtain an adequate specimen for in room cytologic evaluation as determined by our cytopathologist. This will be defined as a sample that is representative (not necessarily diagnostic) of the lesion in question. This will be expressed as a percentage and compared between FNA and FNB | 1 year | |
Secondary | Percentage of Patients in Whom a Diagnosis is Achieved After Crossover (%) | As above. Crossover to FNA or FNB occurs after 3 passes without adequate material | 1 yr |
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