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Head to Head Comparison of Two Needles EUS Guided FNB

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ClinicalTrials.gov Identifier: NCT02534246
Recruitment Status : Withdrawn
First Posted : August 27, 2015
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
John M. Levenick, Milton S. Hershey Medical Center

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : August 2016
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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



Primary Outcome Measures :
  1. Direct Comparison of pancreatic mass histologic tissue adequacy using two EUS guided fine needle biopsy needles [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534246


Locations
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United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: John M Levenick, MD Milton S. Hershey Medical Center
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Responsible Party: John M. Levenick, Assistance Professor of Medicine, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02534246    
Other Study ID Numbers: STUDY2970
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016
Keywords provided by John M. Levenick, Milton S. Hershey Medical Center:
Core tissue biopsy
Core needle biopsy
EUS
Fine needle biopsy
Fine needle aspiration
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases