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SharkCore Versus Acquire FNB

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ClinicalTrials.gov Identifier: NCT03672032
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Henning Gerke, University of Iowa

Brief Summary:

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) has been established as an effective technique for sampling tissue inside and around the gastrointestinal tract, including the pancreas, liver, lymph nodes, and adrenal glands. EUS-FNA is convenient, minimally invasive, and safe procedure with an estimated sensitivity of 75%-92% and a specificity of 82%-100%.

Diagnosis of various pathologies in the GI tract including solid pancreatic masses, mediastinal or gastric lymph nodes, gastrointestinal submucosal lesions, and peri-rectal lesions require adequate tissue architecture and immunohistochemical analysis. This is difficult to obtain and is frequently insufficient with EUS-FNA cytology alone. The core tissue is required to improve the diagnostic yield and obtain histologic diagnosis along with immunostaining to establish specimen adequacy. In past 1 year two new needle EUS needle (Shark Core)and Acquire EUS needles has been introduced to improve diagnostic accuracy, tissue yield, and potentially obtain a core tissue sample. So far, no prospective studies have compared these two needles to see which one is better for overall diagnostic accuracy. Our goal is to perform a prospective analysis to compare the diagnostic yield and safety profile of these 2 new EUS needle.


Condition or disease Intervention/treatment Phase
EUS Guided Biopsy Device: SharkCore Needle Device: Acquire Needle Not Applicable

Detailed Description:

Subjects will come to a pre-procedure room on the day of the procedure. The investigator will again go over the risk and benefit of procedure and indication of the procedure. Once the consent form is signed, a large bore IV cannula is placed and the subject will be taken to the DHC procedure room. Once all the team members required to perform the procedure are in the room we will do a time-out to make sure current patient and procedure are performed. A time-out is done by asking the subject to tell his full name with date of birth and describe in his own words what procedure is planned for subject today. If all the things match the investigator will go ahead and start the sedation.

All EUS-FNB will be performed in the standard manner using linear echoendoscopes. All EUS-FNB procedures were performed by 1 of 2 highly experienced endosonographers (Henning Gerke or Rami EL-Abiad).

The needle to be used (SharkCore vs Acquire) will be decided based on randomization software. The needle will then be used to puncture the target lesion in standard fashion. Aspirated cellular materials will be expressed into the slide by advancing the stylet. The remainder will be expressed onto filter paper and submitted for cell block preparation. The subject's medical information including diagnosis, date of diagnosis, date of admission, blood test results, and medications received will be reviewed for analysis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Randomized Controlled Trial Comparing SharkCore FNB Needles With Acquire FNB Needles Regarding Specimen Quality and Diagnostic Accuracy
Actual Study Start Date : October 29, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Active Comparator: SharkCore Needle Device: SharkCore Needle
SharkCore Needle will be used to obtain biopsy

Active Comparator: Acquire Needle Device: Acquire Needle
Acquire Needle will be used to obtain biopsy




Primary Outcome Measures :
  1. Is the Acquire Needle non-inferior compared to SharkCore Needle in histologic yield of the sample obtained? [ Time Frame: 12 months ]
    A pathologist blinded to clinical information will access each Biopsy specimen for adequacy (scoring system where scores of 0 were samples with no material, 1 - sufficient material for limited cytological interpretation; probably not representative, 2 - sufficient material for adequate cytological interpretation, 3 - sufficient material for limited histological interpretation, 4 - sufficient material for adequate histological interpretation, low quality (total material < 1 10 power field in length, 5 - sufficient material for adequate histological interpretation, high quality (> 1 10 power field in length)


Secondary Outcome Measures :
  1. Is the Acquire Needle non-inferior compared to SharkCore Needle in diagnostic accuracy? [ Time Frame: 12 months ]

    The diagnostic accuracy was calculated considering malignant diagnoses as a true positive.

    A histological or cytological diagnosis of a neoplastic lesion will be considered correct since false-positive diagnoses have been reported to be rare if strict cytological criteria are applied.

    The criterion standard for diagnosis of benign, non-neoplastic lesion that will not undergo surgical resection will be based on a combination of clinal impression, imaging characteristics and a clinical course that was consistent with the study diagnosis.


  2. Is the Acquire Needle non-inferior compared to SharkCore Needle in number of needle passes required to obtain the tissue sample? [ Time Frame: 12 months ]
    We will be collecting data on how many needle passes are required to get adequate FNB sample for each procedure. In the end, we will use this data to calculate using standard statistical measures to compare the average number of passes required to get adequate sample by both SharkCore and Acquire needle.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients schedule for EUS guided biopsy

Exclusion Criteria:

  • Patients who had EUS-FNA for cystic fluid aspiration
  • Pregnant females
  • International normalized ratio >1.5 and platelet count < 50,000
  • Medically unstable

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): NCT03672032


Contacts
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Contact: Henning Gerke, MD 319-384-6582 henning-gerke@uiowa.edu
Contact: Munish Ashat, MD 319-353-4574 munish-ashat@uiowa.edu

Locations
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United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52402
Contact: Henning Gerke, MD    319-384-6582    henning-gerke@uiowa.edu   
Sponsors and Collaborators
Henning Gerke
Investigators
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Principal Investigator: Henning Gerke, MD University of Iowa

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Responsible Party: Henning Gerke, MD, Clinical Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03672032    
Other Study ID Numbers: 201808820
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will not be sharing IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes