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

Johns Hopkins University

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Conditions

Mesenchymal Tumor Autoimmune Pancreatitis Lymphoma Solid Tumors

Interventions

EUS-FNB with ProCore needlePROCEDURE

The use of the standard ProCore needle to acquire diagnostic tissue

EUS-FNB with SharkCore needlePROCEDURE

The use of new SharkCore needle to acquire diagnostic tissue

ProCore needleDEVICE

This is the standard needle used currently to procure tissue from lesions under endoscopic ultrasound guidance

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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)

Locations (1)

Johns Hopkins Hospital

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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

Time frame: Up to 1 month

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: During procedure

Data from ClinicalTrials.gov

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