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

NCT ID: NCT02766842

Last Updated: 2017-05-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-02-28

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.

Conditions

Mesenchymal Tumor; Autoimmune Pancreatitis; Lymphoma; Solid Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

EUS-FNB with ProCore needle

Intervention Type: PROCEDURE

The use of the standard ProCore needle to acquire diagnostic tissue

ProCore needle

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

EUS-FNB with SharkCore needle

Intervention Type: PROCEDURE

The use of new SharkCore needle to acquire diagnostic tissue

SharkCore needle

Intervention Type: DEVICE

This is the new FDA approved needle for tissue procurement under endoscopic ultrasound guidance.

Interventions

EUS-FNB with ProCore needle

The use of the standard ProCore needle to acquire diagnostic tissue

Intervention Type: PROCEDURE

EUS-FNB with SharkCore needle

The use of new SharkCore needle to acquire diagnostic tissue

Intervention Type: PROCEDURE

ProCore needle

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

Intervention Type: DEVICE

SharkCore needle

This is the new FDA approved needle for tissue procurement under endoscopic ultrasound guidance.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Mouen Khashab

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mouen Khashab, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00095614

Identifier Type: -

Identifier Source: org_study_id