<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/NCT03766659</url>
  </required_header>
  <id_info>
    <org_study_id>MORE</org_study_id>
    <nct_id>NCT03766659</nct_id>
  </id_info>
  <brief_title>EUS-FNB With MOSE vs EUS-FNA With ROSE</brief_title>
  <acronym>MORE</acronym>
  <official_title>Endoscopic Ultrasound-guided Fine Needle Biopsy With Macroscopic On-Site Evaluation vs Fine Needle Aspiration With Rapid On-Site Evaluation for Solid Pancreatic Lesions: A Multi-centered Prospective Randomized Controlled Trial (MORE Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</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>
      Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is an indispensable tool for&#xD;
      tissue acquisition for pancreatic lesions. However, FNA alone has several limitations&#xD;
      including inadequate acquisition of cells, and unable to provide core tissue for further&#xD;
      histological analysis. The use of rapid on-site evaluation (ROSE) by cytopathologist has the&#xD;
      biggest impact on improving diagnostic accuracy and is regarded as the gold standard for&#xD;
      EUS-FNA. Unfortunately, it is not widely available due to limited resources.&#xD;
&#xD;
      In order to overcome these limitations, new fine needle biopsy (FNB) needles have been&#xD;
      recently developed to collect not only cells but also the entire core tissue for histological&#xD;
      analysis. Having core biopsy with preserved tissue provides additional advantages of allowing&#xD;
      molecular analysis, which are of emerging importance in cancer management. Early results&#xD;
      comparing FNB with FNA showed the superiority of FNB over FNA in the absence of ROSE. Data&#xD;
      comparing FNB and FNA with ROSE are limited. In order to study to true merits of FNB over&#xD;
      FNA, comparison with the most optimal method is necessary.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to compare the diagnostic yield of EUS-FNB with MOSE vs EUS-FNA&#xD;
      with ROSE.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 19, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2023</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>
    <intervention_model_description>International multicenter prospective randomized comparative study.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic yield</measure>
    <time_frame>1 month after Procedure</time_frame>
    <description>the proportion of patients with adequate tissue for diagnosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>morbidity rate</measure>
    <time_frame>1 month after Procedure</time_frame>
    <description>Procedure-related morbidity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">340</enrollment>
  <condition>Pancreatic Neoplasms</condition>
  <arm_group>
    <arm_group_label>MOSE</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>EUS-FNB with MOSE</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ROSE</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>EUS-FNA with ROSE</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MOSE</intervention_name>
    <description>EUS-FNB with MOSE</description>
    <arm_group_label>MOSE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ROSE</intervention_name>
    <description>EUS-FNA with ROSE</description>
    <arm_group_label>ROSE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 18 and 80 years&#xD;
&#xD;
          -  Referred for EUS-guided tissue acquisition of solid pancreatic lesions greater than&#xD;
             1cm in the largest diameter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Altered anatomy&#xD;
&#xD;
          -  Contraindications for conscious sedation&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Those who cannot provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Charing CHONG</last_name>
    <phone>3505 3933</phone>
    <email>chongcn@surgery.cuhk.edu.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Philip Yeung</last_name>
    <phone>3404 3933</phone>
    <email>philipyeung@surgery.cuhk.edu.hk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Surgery; The Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Charing C Chong, MBChB</last_name>
      <phone>852-26321496</phone>
      <email>Chongcn@surgery.cuhk.edu.hk</email>
    </contact>
    <investigator>
      <last_name>Charing C Chong, MBChB</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>February 9, 2023</last_update_submitted>
  <last_update_submitted_qc>February 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Charing Chong, MD</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</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/NCT03766659
org study id: MORE
nct id: NCT03766659
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is an indispensable tool for
      tissue acquisition for pancreatic lesions. However, FNA alone has several limitations
      including inadequate acquisition of cells, and unable to provide core tissue for further
      histological analysis. The use of rapid on-site evaluation (ROSE) by cytopathologist has the
      biggest impact on improving diagnostic accuracy and is regarded as the gold standard for
      EUS-FNA. Unfortunately, it is not widely available due to limited resources.

      In order to overcome these limitations, new fine needle biopsy (FNB) needles have been
      recently developed to collect not only cells but also the entire core tissue for histological
      analysis. Having core biopsy with preserved tissue provides additional advantages of allowing
      molecular analysis, which are of emerging importance in cancer management. Early results
      comparing FNB with FNA showed the superiority of FNB over FNA in the absence of ROSE. Data
      comparing FNB and FNA with ROSE are limited. In order to study to true merits of FNB over
      FNA, comparison with the most optimal method is necessary.
The purpose of this study is to compare the diagnostic yield of EUS-FNB with MOSE vs EUS-FNA
      with ROSE.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: International multicenter prospective randomized comparative study.
primary purpose: Diagnostic
masking: Single (Participant)
measure: Diagnostic yield
time frame: 1 month after Procedure
description: the proportion of patients with adequate tissue for diagnosis
measure: morbidity rate
time frame: 1 month after Procedure
description: Procedure-related morbidity
arm group label: MOSE
arm group type: Other
description: EUS-FNB with MOSE
arm group label: ROSE
arm group type: Other
description: EUS-FNA with ROSE
intervention type: Diagnostic Test
intervention name: MOSE
description: EUS-FNB with MOSE
arm group label: MOSE
intervention type: Diagnostic Test
intervention name: ROSE
description: EUS-FNA with ROSE
arm group label: ROSE
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Charing CHONG
phone: 3505 3933
email: chongcn@surgery.cuhk.edu.hk
last name: Philip Yeung
phone: 3404 3933
email: philipyeung@surgery.cuhk.edu.hk
facility: 
status: Recruiting
contact: 
investigator: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Charing Chong, MD
investigator title: Dr
mesh term: Pancreatic Neoplasms