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

NCT02766842 | Withdrawn Phase 2 DMC

• 1 other identifier: IRB00095614
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Mesenchymal Tumor; Autoimmune Pancreatitis; Lymphoma; Solid Tumors

Keywords

SharkCore; ProCore

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of passes to procure core tissue from needle

  During procedure

• Safety of tissue procurement by needle

  Up to 1 year

• Procedure time

  During procedure

Study Arms (2)

EUS-FNB with ProCore needle

ACTIVE COMPARATOR

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; Device: ProCore needle

EUS-FNB with SharkCore needle

ACTIVE COMPARATOR

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; Device: SharkCore needle

Interventions

EUS-FNB with ProCore needle PROCEDURE

The use of the standard ProCore needle to acquire diagnostic tissue

EUS-FNB with ProCore needle

EUS-FNB with SharkCore needle PROCEDURE

The use of new SharkCore needle to acquire diagnostic tissue

EUS-FNB with SharkCore needle

ProCore needle DEVICE

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

EUS-FNB with ProCore needle

SharkCore needle DEVICE

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

EUS-FNB with SharkCore needle

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Autoimmune Pancreatitis; Lymphoma

Condition Hierarchy (Ancestors)

Pancreatitis, Chronic; Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders

Study Officials

• Mouen Khashab, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 10, 2016
• Study Start: April 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: May 15, 2017

Record last verified: 2017-05

Locations

US (1)