Head to Head Comparison of Two Needles EUS Guided FNB

NCT02534246 | Withdrawn DMC

• 1 other identifier: STUDY2970
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate and compare the diagnostic accuracy and specimen adequacy of two ultrasound biopsy needles. These are two existing FDA approved tissue biopsy regimens, with respect to diagnosis of solid pancreatic lesions.

Conditions

Pancreatic Tumor

Keywords

Core tissue biopsy; Core needle biopsy; EUS; Fine needle biopsy; Fine needle aspiration

Outcome Measures

Primary Outcomes (1)

• Direct Comparison of pancreatic mass histologic tissue adequacy using two EUS guided fine needle biopsy needles

  Head to head comparison of tissue adequacy for solid pancreatic lesions using two 25 gauge EUS guided fine needle biopsy platforms - ProCore vs SharkCore.

  1year

Study Arms (2)

Pro Core EUS guided Fine Needle Biopsy

EXPERIMENTAL

Echo Tip ProCore ultrasound biopsy needle (Cook Medical 25 gauge) with reverse bevel design for diagnosis of pancreatic lesions.

Device: Ultrasound biopsy needle Echo Tip ProCore

Shark Core EUS guided Fine Needle Biopsy

EXPERIMENTAL

SharkCore ultrasound biopsy needle (Medtronic \[Beacon\] 25 gauge) with six cutting edge surfaces and an opposing bevel design for diagnosis of pancreatic lesions.

Device: Ultrasound biopsy needle SharkCore

Interventions

Ultrasound biopsy needle Echo Tip ProCore DEVICE

Two passes preformed with Echo Tip ProCore ultrasound biopsy needle (Cook Medical 25 gauge) and two passes will be performed using SharkCore ultrasound biopsy needle (Medtronic \[Beacon\] 25 gauge) from single lesion.

Pro Core EUS guided Fine Needle Biopsy

Ultrasound biopsy needle SharkCore DEVICE

Shark Core EUS guided Fine Needle Biopsy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects aged 18-90 of any gender, ethnicity and race that are referred to endoscopy for endoscopic ultrasound guided tissue acquisition for solid pancreatic mass.
• Voluntary enrollment
• Ability to give written informed consent
• Subjects must have a pancreatic mass detected by radiology (CT or MRI) or ultrasound or at the time of EUS.

You may not qualify if:

• Patients with coagulopathy with an elevated INR\>2
• Any individual who cannot provide one's voluntary informed written consent.
• Any pre-existing or discovered medical condition that may at the discretion of investigator interfere with the completion of and/ or participation in existing protocol.
• Pregnancy
• Less than 18 years old

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• John M Levenick, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistance Professor of Medicine

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: August 27, 2015
• Study Start: August 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2017
• Last Updated: September 13, 2016

Record last verified: 2016-09

Locations

US (1)