Evaluation of a New EUS Guided Biopsy Needle (SharkCore) Comparing to Standard EUS Needle (ProCore)

Study Overview
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Brief Summary
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Diagnosis of lesions of pancreas, the upper gastrointestinal tract, as well as adjacent structures, such as lymph nodes, is still showing advancements especially with the increased use of endoscopic ultrasound. Endoscopic ultrasound-guided fine needle aspiration and fine needle biopsy (EUS-FNA/FNB) have become mainstay diagnostic techniques for these lesions. The purpose of the study is to compare between the currently used, ProCore needles and the new biopsy needle, SharkCore, for the histological diagnosis and evaluation of lesions.

Detailed Description
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Endoscopic ultrasound-guided fine needle aspiration and fine needle biopsy (EUS-FNA/FNB) have become mainstay diagnostic techniques for the diagnosis and evaluation of lesions of the pancreas, the upper gastrointestinal tract, as well as adjacent structures, including lymph nodes. Cytology specimens provided from FNA cannot fully characterize certain neoplasms such as lymphomas or mesenchymal tumors. Core biopsy specimens for histological examinations are needed to provide accurate diagnoses. ProCore needles (ProCore, Wilson-Cook Medical Inc. Winston-Salem, NC) were designed to obtain histological and cytological samples. Studies comparing ProCore needles with standard FNA needles showed no significant difference in diagnostic accuracy, histological core tissue procurement or mean number of passes. To overcome the above mentioned limitations (mainly suboptimal core tissue procurement rates), a new novel SharkCore needle (Beacon Endoscopic, Newton, MA, USA) has been designed and approved for clinical human use by the FDA. The objective of the study is to compare the new EUS guided histology biopsy needle SharkCore to the currently used EUS histology needle, ProCore, for the histological diagnosis and evaluation of lesions.

Official Title
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Evaluation of a New EUS Guided Biopsy Needle (SharkCore) Comparing to Standard EUS Needle (ProCore): A Prospective Randomized, Controlled Multicenter Study

Conditions
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Mesenchymal Tumor, Autoimmune Pancreatitis, Lymphoma, Solid Tumors

Intervention / Treatment
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* Procedure: EUS-FNB with ProCore needle
* Procedure: EUS-FNB with SharkCore needle
* Device: ProCore needle
* Device: SharkCore needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 years of age referred for EUS Lesions requiring histologic diagnosis: Mesenchymal tumors Autoimmune pancreatitis Granulomatous disease Indeterminate hepatitis Confirmatory immunochemistry to establish a diagnosis (i.e. pancreatic neuroendocrine tumor) Lymphoma Solid tumors Previously non-diagnostic FNA Exclusion Criteria: Uncorrectable coagulopathy (INR > 1.5) Uncorrectable thrombocytopenia (platelet < 50,000) Uncooperative patients Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures) Refusal to consent form Cystic lesions Inaccessible lesions to EUS (proximal to sigmoid colon or distal to second duodenum)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EUS-FNB with ProCore needle<br>General anesthesia or conscious sedation will be started and an upper endoscopic ultrasound will be inserted into the participants mouth and advanced to the site of the lesion. The lesion will be punctured by the ProCore needle, then the stylet is completely removed, and negative suction pressure is applied using a 10 ml syringe for 30 seconds while the needle is stationary with the target. Then, the needle is moved back and forth several times within the target, utilizing the fanning technique. Finally, suction is released by closing the lock of the syringe and the needle is removed. | Procedure: EUS-FNB with ProCore needle<br>* The use of the standard ProCore needle to acquire diagnostic tissue<br>Device: ProCore needle<br>* This is the standard needle used currently to procure tissue from lesions under endoscopic ultrasound guidance<br>|
| Active Comparator: EUS-FNB with SharkCore needle<br>The procedure will be done in the same manner with same endoscopic technique and method of tissue procurement. The only difference will be using the SharkCore needle to acquire tissue. | Procedure: EUS-FNB with SharkCore needle<br>* The use of new SharkCore needle to acquire diagnostic tissue<br>Device: SharkCore needle<br>* This is the new FDA approved needle for tissue procurement under endoscopic ultrasound guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of needle as assessed by diagnostic yield of needle and final diagnosis method | The final diagnosis of tissue from needle will be compared to the final diagnosis reached either by surgical removal of mass or other method of biopsy | Up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of passes to procure core tissue from needle | The number of passes needed to acquire core tissue as assessed by the pathologist in the room. | During procedure | 
| Safety of tissue procurement by needle | All complications related to needle used will be recorded with a preset questionnaire to measure the frequency of complications related to needle used. | Up to 1 year | 
| Procedure time | Time required to acquire tissue using each needle will be recorded from time of needle insertion to time of core tissue procurement as per pathologist. | During procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SharkCore, ProCore