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

Brief Title

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

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Diagnostic accuracy of needle as assessed by diagnostic yield of needle and final diagnosis method

Secondary Outcome

 Number of passes to procure core tissue from needle

Condition

Mesenchymal Tumor

Intervention

EUS-FNB with ProCore needle

Study Arms / Comparison Groups

 EUS-FNB with ProCore needle
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

0

Start Date

April 2016

Completion Date

February 2017

Primary Completion Date

February 2017

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)
      

Gender

All

Ages

18 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

Mouen Khashab, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02766842

Organization ID

IRB00095614


Responsible Party

Principal Investigator

Study Sponsor

Johns Hopkins University


Study Sponsor

Mouen Khashab, MD, Principal Investigator, Johns Hopkins University


Verification Date

May 2017