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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreatic Cancer, Lymphadenopathy, Gastrointestinal Stromal Tumor

Intervention / Treatment
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* Device: Fine needle aspiration
* Device: Fine needle biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fine needle aspiration<br>fine needle aspiration | Device: Fine needle aspiration<br>* Fine needle aspiration<br>* Other names: Echo Tip FNA Needle;Device: Fine needle biopsy<br>* FNB<br>* Other names: Echo Tip Procore;|
| Active Comparator: Fine needle biopsy<br>Fine needle biopsy | Device: Fine needle aspiration<br>* Fine needle aspiration<br>* Other names: Echo Tip FNA Needle;Device: Fine needle biopsy<br>* FNB<br>* Other names: Echo Tip Procore;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FNB, EUS, FNA