Head to Head Comparison of Two Needles EUS Guided FNB

Sponsor

Milton S. Hershey Medical Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02534246

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Tumor	Device: Ultrasound biopsy needle Echo Tip ProCore Device: Ultrasound biopsy needle SharkCore	N/A

Detailed Description

EUS guided core biopsy using various needle designs and sizes, seems to be a promising technique to procure tissue in solid pancreatic masses for making an accurate histological diagnosis. EUS-guided core biopsies of pancreas may aid in patients with non-diagnostic EUS-FNA samples and institutions where they do not have on-site cytopathology available for prompt evaluation of tissue adequacy. Making an accurate diagnosis not only assists in planning appropriate treatment but also may decrease morbidity/mortality from unnecessary surgeries.

Our goal is to evaluate and compare the diagnostic accuracy and specimen adequacy of the Cook Medical 25 gauge ProCore ultrasound biopsy needle and the Medtronic (Beacon) 25 gauge SharkCore ultrasound biopsy needle. We hypothesize the endoscopic ultrasound tissue biopsy will not be different in diagnostic accuracy of solid pancreatic lesions when using a 25 gauge SharkCore ultrasound biopsy needle in comparison with the 25 gauge ProCore ultrasound biopsy needle.

This is a non- inferior paired, prospective, single-blind study design in which patients undergoing EUS for a solid pancreatic mass. Two biopsies with each of the two endoscopic needles of interest in this study will be used in random order. The biopsy needle passed first will be randomized, after which the two needles will be alternated for each of the remaining biopsies. Randomization will occur in permuted blocks of 3. Physician will record the ease/ difficulty of obtaining each of the 4 biopsies on a scale of 1 to 5. Also, they record the needle visibility on ultrasound. The biopsy site will be examined for evidence of bleeding. Biopsies will be sent to the pathology laboratory in a blinded fashion in coded containers, where pathologist determine the number of adequate biopsies out of two passes of each needle.The pathologist will also provide a scale of perceived diagnostic usefulness of material in a blinded fashion. Post procedure care will including a letter to referring physician with recommendations for treatment and follow up.

This study include 30 patients referred to Hershey Medical Center.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Diagnostic

Official Title:

A Paired Prospective, Single Blinded Study of the Diagnostic Accuracy and Specimen Adequacy of Two Endoscopic Tissue Biopsy Needles for Diagnosis Solid Pancreatic Mass

Study Start Date :

Aug 1, 2016

Anticipated Primary Completion Date :

Oct 1, 2016

Anticipated Study Completion Date :

Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pro Core EUS guided Fine Needle Biopsy 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 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.
Experimental: Shark Core EUS guided Fine Needle Biopsy 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

Arm

Intervention/Treatment

Experimental: Pro Core EUS guided Fine Needle Biopsy

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

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.

Experimental: Shark Core EUS guided Fine Needle Biopsy

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

Outcome Measures

Primary Outcome Measures

Direct Comparison of pancreatic mass histologic tissue adequacy using two EUS guided fine needle biopsy needles [1year]
Head to head comparison of tissue adequacy for solid pancreatic lesions using two 25 gauge EUS guided fine needle biopsy platforms - ProCore vs SharkCore.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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