Clinical trial NCT02766842: Evaluation of a New EUS Guided Biopsy Needle (SharkCore) Comparing to Standard EUS Needle (ProCore)
Official title: Evaluation of a New EUS Guided Biopsy Needle (SharkCore) Comparing to Standard EUS Needle (ProCore): A Prospective Randomized, Controlled Multicenter Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Mesenchymal Tumor
Autoimmune Pancreatitis
Lymphoma
Solid Tumors
Keywords: SharkCore
ProCore
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Diagnostic accuracy of needle as assessed by diagnostic yield of needle and final diagnosis method
timeFrame: Up to 1 month
Secondary outcomes:
measure: Number of passes to procure core tissue from needle
timeFrame: During procedure
measure: Safety of tissue procurement by needle
timeFrame: Up to 1 year
measure: Procedure time
timeFrame: During procedure
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mouen Khashab, MD
role: PRINCIPAL_INVESTIGATOR
References: