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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Lymphoma; Solid Tumors; Autoimmune Pancreatitis; Mesenchymal Tumor
• Intervention / Treatment: Procedure: EUS-FNB with ProCore needle; Device: ProCore needle; Procedure: EUS-FNB with SharkCore needle; Device: SharkCore needle

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 Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EUS-FNB with ProCore needle; 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; The use of the standard ProCore needle to acquire diagnostic tissue; Device: ProCore needle; This is the standard needle used currently to procure tissue from lesions under endoscopic ultrasound guidance
Active Comparator: EUS-FNB with SharkCore needle; 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; The use of new SharkCore needle to acquire diagnostic tissue; Device: SharkCore needle; This is the new FDA approved needle for tissue procurement under endoscopic ultrasound guidance.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Mouen Khashab, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: May 6, 2016
• First Submitted That Met QC Criteria: May 6, 2016
• First Posted (Estimate): May 10, 2016

Study Record Updates

• Last Update Posted (Actual): May 15, 2017
• Last Update Submitted That Met QC Criteria: May 11, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: ProCore; SharkCore
• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Autoimmune Diseases; Pancreatic Diseases; Pancreatitis, Chronic; Pancreatitis; Autoimmune Pancreatitis
• Other Study ID Numbers: IRB00095614

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided