Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle

Not Applicable

Completed

Conditions: Lymphadenopathy
Gastrointestinal Stromal Tumor
Pancreatic Cancer

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

3.1.1 All patients referred for EUS tissue sampling who provide informed consent

Exclusion Criteria

3.2.2 Diagnostic EUS determines lesion is not amenable to FNA or FNB

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Diagnostic Yield of EUS-FNB and EUS-FNA	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Specimen Adequacy as Assessed by Rapid-onsite Evaluation of FNA and FNB	1 year	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
Percentage of Patients in Whom a Diagnosis is Achieved After Crossover (%)	1 yr	As above. Crossover to FNA or FNB occurs after 3 passes without adequate material

Locations (3): UCLA Medical Center
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Los Angeles, California, United States
California Pacific Medical Center
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San Francisco, California, United States
Moffit Cancer Center
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Tampa, Florida, United States