<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/NCT03753815</url>
  </required_header>
  <id_info>
    <org_study_id>ZS-1767</org_study_id>
    <nct_id>NCT03753815</nct_id>
  </id_info>
  <brief_title>Diagnostic Yield of FNA Needle and FNB Needle for Autoimmune Pancreatitis</brief_title>
  <official_title>A Randomized Trial Comparing a 19-gauge EUS Fine-needle Aspiration Device With a 20-gauge Fine-needle Biopsy Device for the Diagnosis of Autoimmune Pancreatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to compare the diagnostic accuracy of two EUS-guided tissue&#xD;
      acquisition devices; the 19G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G&#xD;
      Echotip ProCore Fine Needle Biopsy (FNB) device for the diagnosis of autoimmune pancreatitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endoscopic ultrasound (EUS)-guided tissue acquisition has emerged as a valuable method to&#xD;
      diagnose autoimmune pancreatitis (AIP) and exclude malignancy. During Endoscopic Ultrasound&#xD;
      (EUS), tissue samples can be obtained for pathological evaluation with different devices.&#xD;
      Previous studies suggest 19-gauge fine needle aspiration (FNA) needle provides a reliable&#xD;
      specimen for diagnosis of AIP. However tissue architecture and cell morphology are essential&#xD;
      for accurate pathological assessment. Therefore, pathologists generally prefer a histological&#xD;
      specimen. Fine needle biopsy (FNB) has the advantage of obtaining a histological specimen,&#xD;
      which may lead to better diagnostic performance. However, the superiority of histology over&#xD;
      cytology in EUS-guided tissue sampling for diagnosis of AIP has not been proven yet. In this&#xD;
      study, we aim to compare the diagnostic accuracy of two EUS-guided tissue acquisition&#xD;
      devices; the 19G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G Echotip&#xD;
      ProCore Fine Needle Biopsy (FNB) device for the diagnosis of autoimmune pancreatitis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 22, 2018</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">October 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic accuracy (compared to the gold standard diagnosis)</measure>
    <time_frame>24 months</time_frame>
    <description>Gold standard diagnosis is defined as: based on the conclusions of the diagnostic work-up (combined outcomes of tissue sampling and imaging studies), and confirmed by a compatible clinical disease course of at least 12 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical success</measure>
    <time_frame>24 months</time_frame>
    <description>tissue acquisition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of the tissue sample</measure>
    <time_frame>within 2 weeks after the EUS procedure and after 24 months</time_frame>
    <description>Quality, defined as; presence of core tissue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of the tissue sample</measure>
    <time_frame>within 2 weeks after the EUS procedure and after 24 months</time_frame>
    <description>Quantity, defined as; presence of remnant material after diagnosis was obtained and sufficiency for advanced diagnostic processing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic yield of the first needle pass</measure>
    <time_frame>within 2 weeks after the EUS procedure and after 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>first 24 hours until - 24 months after procedure</time_frame>
    <description>Safety</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">46</enrollment>
  <condition>Autoimmune Pancreatitis</condition>
  <arm_group>
    <arm_group_label>19G FNA needle</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients referred for EUS-guided tissue acquisition of AIP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>20G FNB needle</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients referred for EUS-guided tissue acquisition of AIP</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>19G FNA needle</intervention_name>
    <description>Puncture of AIP under Endoscopic Ultrasonography, with a 19-gauge FNA needle</description>
    <arm_group_label>19G FNA needle</arm_group_label>
    <other_name>19G Echotip Ultra Fine Needle Aspiration (FNA) device</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>20G FNB needle</intervention_name>
    <description>Puncture of AIP under Endoscopic Ultrasonography, with a 20-gauge FNB needle</description>
    <arm_group_label>20G FNB needle</arm_group_label>
    <other_name>20G Echotip ProCore Fine Needle Biopsy (FNB) device</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients referred for EUS-guided tissue acquisition because of clinical suspicion of&#xD;
             AIP&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh&#xD;
             frozen plasma (FFP)&#xD;
&#xD;
          -  Use of anticoagulants that cannot be discontinued in order to guarantee an INR below&#xD;
             1.5&#xD;
&#xD;
          -  Previous inclusion in the current study&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aiming Yang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospitalollege Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aiming Yang, M.D.</last_name>
    <phone>+86-010-69151593</phone>
    <email>yangaiming@medmail.com.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yunlu Feng, M.D.</last_name>
    <phone>+86-010-69151591</phone>
    <email>yunluf@icloud.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aiming Yang, M.D.</last_name>
      <phone>+86-10-69151593</phone>
      <email>yangaiming@medmail.com.cn</email>
    </contact>
    <contact_backup>
      <last_name>Yunlu Feng, M.D.</last_name>
      <phone>+86-10-69151591</phone>
      <email>yunluf@icloud.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>April 28, 2021</last_update_submitted>
  <last_update_submitted_qc>April 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
    <mesh_term>Autoimmune Pancreatitis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03753815
org study id: ZS-1767
nct id: NCT03753815
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to compare the diagnostic accuracy of two EUS-guided tissue
      acquisition devices; the 19G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G
      Echotip ProCore Fine Needle Biopsy (FNB) device for the diagnosis of autoimmune pancreatitis.
Endoscopic ultrasound (EUS)-guided tissue acquisition has emerged as a valuable method to
      diagnose autoimmune pancreatitis (AIP) and exclude malignancy. During Endoscopic Ultrasound
      (EUS), tissue samples can be obtained for pathological evaluation with different devices.
      Previous studies suggest 19-gauge fine needle aspiration (FNA) needle provides a reliable
      specimen for diagnosis of AIP. However tissue architecture and cell morphology are essential
      for accurate pathological assessment. Therefore, pathologists generally prefer a histological
      specimen. Fine needle biopsy (FNB) has the advantage of obtaining a histological specimen,
      which may lead to better diagnostic performance. However, the superiority of histology over
      cytology in EUS-guided tissue sampling for diagnosis of AIP has not been proven yet. In this
      study, we aim to compare the diagnostic accuracy of two EUS-guided tissue acquisition
      devices; the 19G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G Echotip
      ProCore Fine Needle Biopsy (FNB) device for the diagnosis of autoimmune pancreatitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: Diagnostic accuracy (compared to the gold standard diagnosis)
time frame: 24 months
description: Gold standard diagnosis is defined as: based on the conclusions of the diagnostic work-up (combined outcomes of tissue sampling and imaging studies), and confirmed by a compatible clinical disease course of at least 12 months
measure: Technical success
time frame: 24 months
description: tissue acquisition
measure: Quality of the tissue sample
time frame: within 2 weeks after the EUS procedure and after 24 months
description: Quality, defined as; presence of core tissue
measure: Quantity of the tissue sample
time frame: within 2 weeks after the EUS procedure and after 24 months
description: Quantity, defined as; presence of remnant material after diagnosis was obtained and sufficiency for advanced diagnostic processing
measure: Diagnostic yield of the first needle pass
time frame: within 2 weeks after the EUS procedure and after 24 months
measure: Adverse events
time frame: first 24 hours until - 24 months after procedure
description: Safety
arm group label: 19G FNA needle
arm group type: Active Comparator
description: Patients referred for EUS-guided tissue acquisition of AIP
arm group label: 20G FNB needle
arm group type: Active Comparator
description: Patients referred for EUS-guided tissue acquisition of AIP
intervention type: Device
intervention name: 19G FNA needle
description: Puncture of AIP under Endoscopic Ultrasonography, with a 19-gauge FNA needle
arm group label: 19G FNA needle
other name: 19G Echotip Ultra Fine Needle Aspiration (FNA) device
intervention type: Device
intervention name: 20G FNB needle
description: Puncture of AIP under Endoscopic Ultrasonography, with a 20-gauge FNB needle
arm group label: 20G FNB needle
other name: 20G Echotip ProCore Fine Needle Biopsy (FNB) device
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Aiming Yang, M.D.
role: Principal Investigator
affiliation: Peking Union Medical College Hospitalollege Hospital
last name: Aiming Yang, M.D.
phone: +86-010-69151593
email: yangaiming@medmail.com.cn
last name: Yunlu Feng, M.D.
phone: +86-010-69151591
email: yunluf@icloud.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor
mesh term: Pancreatitis
mesh term: Autoimmune Pancreatitis