<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02979509</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201600783</org_study_id>
    <nct_id>NCT02979509</nct_id>
  </id_info>
  <brief_title>Evaluation of Diagnostic Yield of EUS-Guided Tissue Sampling</brief_title>
  <official_title>Multi-center Prospective Evaluation of the Diagnostic Yield of Endoscopic Ultrasound-Guided Tissue Sampling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Borland Groover Clinic, Jacksonville, FL</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northwestern University, Chicago, IL</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Montefiore Medical Center, Bronx, NY</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>New York University, New York, NY</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Geisinger Medical Center, Danville, PA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ochsner Health System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      All patients will receive standard medical care and no experimental interventions will be&#xD;
      performed. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a&#xD;
      well-established procedure commonly used for the investigation of lesions within or adjacent&#xD;
      to the gastrointestinal (GI) lumen (i.e. pancreas, liver, mediastinal masses, left adrenal&#xD;
      gland, lymph nodes, and subepithelial lesions). EUS-guided tissue sampling has been commonly&#xD;
      performed with different size and types of aspiration and core biopsy needles.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a well-established procedure&#xD;
      commonly used for the investigation of lesions within or adjacent to the gastrointestinal&#xD;
      (GI) lumen (i.e. pancreas, liver, mediastinal masses, left adrenal gland, lymph nodes, and&#xD;
      subepithelial lesions). EUS-guided tissue sampling has been commonly performed with different&#xD;
      size and types of aspiration and core biopsy needles. More recently, a novel&#xD;
      through-the-needle microforceps has been introduced. The MorayTM microforceps fits through a&#xD;
      19-gauge FNA needle and allows targeted tissue sampling under EUS visualization.&#xD;
&#xD;
      Aim - To prospectively evaluate the safety and diagnostic yield of the through-the-needle&#xD;
      microforceps for pancreatic and non-pancreatic solid, cystic and mixed solid/cystic lesions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Actual">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall diagnostic yield of EUS-TS</measure>
    <time_frame>2 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic Yield of EUS-guided tissue sampling solid lesions</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic Yield of EUS-guided tissue sampling cystic lesions</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic yield of EUS-TS using through-the-needle micro forceps</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic yield of EUS-TS using fine-needle aspiration</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic yield of EUS-TS using core biopsy needle</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of adverse events associated with EUS-TS</measure>
    <time_frame>48 hours</time_frame>
    <description>Adverse events defined based on previously established criteria by the American Society of Gastrointestinal Endoscopy (ASGE)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">54</enrollment>
  <condition>Gastroenterology</condition>
  <condition>Lesions</condition>
  <arm_group>
    <arm_group_label>Endoscopic ultrasound- (EUS) guided tissue sampling</arm_group_label>
    <description>All patients scheduled to undergo EUS with tissue sampling (TS) as medically indicated will be considered for the study. Patients in whom EUS-TS is considered as part of their standard medical care will be offered to participate in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Endoscopic ultrasound- (EUS) guided tissue sampling</intervention_name>
    <description>EUS- guided tissue sampling of solid and/or cystic pancreatic and non-pancreatic lesions as part of their medical care.</description>
    <arm_group_label>Endoscopic ultrasound- (EUS) guided tissue sampling</arm_group_label>
    <other_name>EUS-TS</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will include all patients who are scheduled to undergo EUS-guided tissue sampling&#xD;
        as part of their standard of care.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt;18 years old&#xD;
&#xD;
          2. Patients referred for EUS-guided tissue sampling for lesions (i.e. pancreas, liver,&#xD;
             mediastinal masses, left adrenal gland, lymph nodes, and subepithelial lesions).&#xD;
&#xD;
          3. Target lesion should be ≥ 15 mm in size (long axis).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any contraindication to performing endoscopy&#xD;
&#xD;
          2. Unable to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dennis Yang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>January 2, 2020</last_update_submitted>
  <last_update_submitted_qc>January 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Computer-based files will only be made available to personnel involved in the study through the use of access privileges, passwords and encryption. The prospectively maintained database will be constructed with the Research Electronic Data Capture software.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02979509
org study id: IRB201600783
nct id: NCT02979509
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
All patients will receive standard medical care and no experimental interventions will be
      performed. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a
      well-established procedure commonly used for the investigation of lesions within or adjacent
      to the gastrointestinal (GI) lumen (i.e. pancreas, liver, mediastinal masses, left adrenal
      gland, lymph nodes, and subepithelial lesions). EUS-guided tissue sampling has been commonly
      performed with different size and types of aspiration and core biopsy needles.
Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a well-established procedure
      commonly used for the investigation of lesions within or adjacent to the gastrointestinal
      (GI) lumen (i.e. pancreas, liver, mediastinal masses, left adrenal gland, lymph nodes, and
      subepithelial lesions). EUS-guided tissue sampling has been commonly performed with different
      size and types of aspiration and core biopsy needles. More recently, a novel
      through-the-needle microforceps has been introduced. The MorayTM microforceps fits through a
      19-gauge FNA needle and allows targeted tissue sampling under EUS visualization.

      Aim - To prospectively evaluate the safety and diagnostic yield of the through-the-needle
      microforceps for pancreatic and non-pancreatic solid, cystic and mixed solid/cystic lesions.
observational model: Cohort
time perspective: Prospective
measure: Overall diagnostic yield of EUS-TS
time frame: 2 months
measure: Diagnostic Yield of EUS-guided tissue sampling solid lesions
time frame: 2 months
measure: Diagnostic Yield of EUS-guided tissue sampling cystic lesions
time frame: 2 months
measure: Diagnostic yield of EUS-TS using through-the-needle micro forceps
time frame: 2 months
measure: Diagnostic yield of EUS-TS using fine-needle aspiration
time frame: 2 months
measure: Diagnostic yield of EUS-TS using core biopsy needle
time frame: 2 months
measure: Rate of adverse events associated with EUS-TS
time frame: 48 hours
description: Adverse events defined based on previously established criteria by the American Society of Gastrointestinal Endoscopy (ASGE)
arm group label: Endoscopic ultrasound- (EUS) guided tissue sampling
description: All patients scheduled to undergo EUS with tissue sampling (TS) as medically indicated will be considered for the study. Patients in whom EUS-TS is considered as part of their standard medical care will be offered to participate in this study.
intervention type: Other
intervention name: Endoscopic ultrasound- (EUS) guided tissue sampling
description: EUS- guided tissue sampling of solid and/or cystic pancreatic and non-pancreatic lesions as part of their medical care.
arm group label: Endoscopic ultrasound- (EUS) guided tissue sampling
other name: EUS-TS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dennis Yang, MD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Computer-based files will only be made available to personnel involved in the study through the use of access privileges, passwords and encryption. The prospectively maintained database will be constructed with the Research Electronic Data Capture software.