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Endoscopic Ultrasound Guided Fine Needle Biopsy (EUS-FNB-SC) Using a Novel Fork Needle

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ClinicalTrials.gov Identifier: NCT02678442
Recruitment Status : Completed
First Posted : February 9, 2016
Results First Posted : January 6, 2020
Last Update Posted : January 6, 2020
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Michael Wallace, Mayo Clinic

Brief Summary:
This is a clinical trial to compare two needles used in biopsy techniques to acquire tissue from pancreatic cancer. The hypothesis is that the tissue yield, as measured by tumor DNA and cellular material is superior for Flexible Needle Biopsy (FNB) compared with conventional Fine Needle Aspiration (FNA). Specifically, FNB will increase the proportion of cases in which sufficient DNA is obtained to allow genomic profiling and whole exome sequencing.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Device: Fine Needle Biopsy (FNB) Device: Fine Needle Aspiration (FNA) Not Applicable

Detailed Description:
This is a single-blinded randomized controlled trial with paired evaluation of conventional FNA needle versus FNB needle stratified by lesion location (pancreas head tumor versus pancreas body/tail). A minimum of 4 passes ( 2 with each needle) will be performed from all the lesions. After each pass of needle, the on-site cytopathologists will evaluate the adequacy and the degree of the pathological changes in the obtained material. Based on the information provided by the onsite cytopathologists, the endosonographer will repeat the FNA until enough histological material is obtained to confirm a diagnosis. Patients will be assessed immediately after procedure and during the first 30 days with a follow-up.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Pilot-Feasibility Trial of EUS Guided Pancreas Fine Needle Core Biopsy for Whole Exome Sequencing and Genomic Profiling
Study Start Date : May 16, 2016
Actual Primary Completion Date : November 10, 2018
Actual Study Completion Date : November 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Active Comparator: FNB first, then FNA
In an endoscopic ultrasound-guided procedure, Shark Core Fine Needle Biopsy (FNB) will be performed first, followed by Fine Needle Aspiration (FNA).
Device: Fine Needle Biopsy (FNB)
The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites.
Other Name: Shark Core Fine Needle Biopsy

Device: Fine Needle Aspiration (FNA)
Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds.

Active Comparator: FNA first, then FNB
In an endoscopic ultrasound-guided procedure, Fine Needle Aspiration (FNA) will be performed first, followed by Shark Core Fine Needle Biopsy (FNB).
Device: Fine Needle Biopsy (FNB)
The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites.
Other Name: Shark Core Fine Needle Biopsy

Device: Fine Needle Aspiration (FNA)
Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds.




Primary Outcome Measures :
  1. Total DNA Yield of Adenocarcinoma [ Time Frame: Baseline ]
    Total quantity of DNA obtained from first needle pass of adenocarcinoma, measured in ng/µL.


Secondary Outcome Measures :
  1. Total Number of Passes Needed to Obtain Adequate Tissue Sample for Cytology/Histology Diagnosis [ Time Frame: Baseline ]
    The total number of passes required to obtain adequate tissue sample for cytology/histology processing and interpretation.

  2. Core Tissue Length [ Time Frame: Baseline ]
    The length of the tissue core sample acquired, on the first needle pass, measured in centimeters.

  3. Concentration of DNA Yield of Adenocarcinoma [ Time Frame: Baseline ]
    The concentration of the DNA from the adenocarcinoma on the first needle pass, measured in micrograms per microliter.

  4. Percentage of Tumor Cellularity [ Time Frame: Baseline ]
    Percent of tumor cellularity with first pass of adenocarcinoma

  5. Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for Cytologic Interpretation [ Time Frame: Baseline ]
    The total number of subjects whose first-pass biopsy contained adequate material for cytologic interpretation, as determined by a cytopathologist.

  6. Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for High Quality Histologic Interpretation [ Time Frame: Baseline ]
    The number of subjects whose first pass biopsy contained adequate material for high quality histologic interpretation, as determined by a cytopathologist. High quality is defined as being greater than 10 power field in length.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients who are 18 years old or older and are referred for the evaluation of pancreatic mass lesion.
  • International Normalized Ratio (INR) less than 1.5 and platelet count of more than 50,000.
  • Medically stable to undergo sedation for EUS.
  • Signed informed consent

Exclusion Criteria:

  • Medical condition that preclude the patient from having a therapeutic procedure regardless of the EUS finding
  • Pregnant patients

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): NCT02678442


Locations
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United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Medtronic
Investigators
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Principal Investigator: Michael B. Wallace, MD, MPH Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Michael Wallace, Mayo Clinic:
Additional Information:
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Responsible Party: Michael Wallace, M.D, MPH, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02678442    
Other Study ID Numbers: 15-007801
First Posted: February 9, 2016    Key Record Dates
Results First Posted: January 6, 2020
Last Update Posted: January 6, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No