<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/NCT04486274</url>
  </required_header>
  <id_info>
    <org_study_id>10-2020</org_study_id>
    <nct_id>NCT04486274</nct_id>
  </id_info>
  <brief_title>Macroscopic on Site Evaluation (MOLSE) vs Standard Specimen Acquisition of Solid Lesions During EUS-FNB</brief_title>
  <acronym>MOSE</acronym>
  <official_title>Macroscopic on Site Evaluation (MOLSE) vs Standard Specimen Acquisition of Solid Lesions During EUS-FNB: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Clinico Humanitas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Humanitas Mater Domini</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istituto Clinico Humanitas</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 ultrasonography (EUS) with tissue acquisition (TA) is nowadays a well-established&#xD;
      technique for the sampling of solid lesions pancreatic and non-pancreatic lesions. Actually&#xD;
      the standard methods to obtain sampling in gastrointestinal (GI) and non-GI solid masses is&#xD;
      the fine needle aspiration (FNA) performed by endoscopic ultrasonography (EUS). Its&#xD;
      sensitivity, specificity and diagnostic accuracy for malignant cytology are actually reported&#xD;
      of 85-95%, 95%-98% and 78-95% respectively. These data could be affected by the presence of&#xD;
      cytopathologist in endoscopy room during the tissue sampling. The rapid on-site evaluation&#xD;
      (ROSE) has been advocated to significantly increase EUS-FNA accuracy. To overcome this&#xD;
      problem fine needle biopsy (FNB) for TA to obtain histological specimens was proposed. These&#xD;
      needles allow as the acquisition of an histological specimen than the cytological one with&#xD;
      FNA needles. Recently, the need to obtain a histological, instead of a cytological, specimen&#xD;
      during EUS has become more urgent and necessary due to innovative oncological treatment&#xD;
      options. An acquired histological specimen could avoid the need of a cytopathologist in the&#xD;
      endoscopic room, diminishing costs, procedures time, number of passes and reducing the&#xD;
      additional costs of a possible repeated EUS-FNA, in case of an inconclusive diagnosis.&#xD;
&#xD;
      With the advent of FNB, the macroscopic on-site evaluation (MOSE) of the specimen by the&#xD;
      endosonographer was proposed, resulting in a comparable alternative to ROSE.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 17, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 31, 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>Sequential Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To assess the diagnostic accuracy of EUS-FNB with MOSE vs EUS-FNB alone.</measure>
    <time_frame>12 Months</time_frame>
    <description>Diagnostic accuracy will be measure</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">370</enrollment>
  <condition>Endoscopic Ultrasonography With Tissue Acquisition</condition>
  <arm_group>
    <arm_group_label>non MOSE arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three needle passes will be performed for each mass</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MOSE arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The endoscopist will perform biopsy until a macroscopic visible core (MVC) will be obtained and specimen will be placed in a container (Container A-MOSE). If the needle passes performed are less than 3 (1 or 2 passes) the specimens acquired in the remnant passes to join standard care of 3 passes, according to ESGE guidelines, will be placed in a second container (Container B).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MOSE</intervention_name>
    <description>After each pass, the stylet will be introduced into the needle, the material will be released onto a smear slide, and a macroscopic on-site quality evaluation (MOSE) of the specimen will be performed by the endoscopist.</description>
    <arm_group_label>MOSE arm</arm_group_label>
    <arm_group_label>non MOSE arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than 18, both genders.&#xD;
&#xD;
          -  Both in-patient and out-patients.&#xD;
&#xD;
          -  Presence of a solid lesion. In the presence of a cystic component, the solid part of&#xD;
             the lesion should be more 75% of the total.&#xD;
&#xD;
          -  FNB performed by a 22G needle Acquire® (Boston Scientific).&#xD;
&#xD;
          -  Tissue acquisition with fanning technique.&#xD;
&#xD;
          -  Obtained informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients underwent EUS-FNA with or without ROSE&#xD;
&#xD;
          -  Patients underwent EUS-FNB plus ROSE.&#xD;
&#xD;
          -  Previous biopsy of the lesion with diagnosis of malignancy&#xD;
&#xD;
          -  Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT)&#xD;
             or partial thromboplastin time (PTT) that does not normalize after administration of&#xD;
             fresh frozen plasma.&#xD;
&#xD;
          -  Pregnancy or breast-feeding.&#xD;
&#xD;
          -  Patients unable to understand and/or read the consent form.&#xD;
&#xD;
          -  Inclusion in other study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gastrointestinal Endoscopy Unit</name>
      <address>
        <city>Castellanza</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04486274
org study id: 10-2020
nct id: NCT04486274
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Endoscopic ultrasonography (EUS) with tissue acquisition (TA) is nowadays a well-established
      technique for the sampling of solid lesions pancreatic and non-pancreatic lesions. Actually
      the standard methods to obtain sampling in gastrointestinal (GI) and non-GI solid masses is
      the fine needle aspiration (FNA) performed by endoscopic ultrasonography (EUS). Its
      sensitivity, specificity and diagnostic accuracy for malignant cytology are actually reported
      of 85-95%, 95%-98% and 78-95% respectively. These data could be affected by the presence of
      cytopathologist in endoscopy room during the tissue sampling. The rapid on-site evaluation
      (ROSE) has been advocated to significantly increase EUS-FNA accuracy. To overcome this
      problem fine needle biopsy (FNB) for TA to obtain histological specimens was proposed. These
      needles allow as the acquisition of an histological specimen than the cytological one with
      FNA needles. Recently, the need to obtain a histological, instead of a cytological, specimen
      during EUS has become more urgent and necessary due to innovative oncological treatment
      options. An acquired histological specimen could avoid the need of a cytopathologist in the
      endoscopic room, diminishing costs, procedures time, number of passes and reducing the
      additional costs of a possible repeated EUS-FNA, in case of an inconclusive diagnosis.

      With the advent of FNB, the macroscopic on-site evaluation (MOSE) of the specimen by the
      endosonographer was proposed, resulting in a comparable alternative to ROSE.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Other
masking: None (Open Label)
measure: To assess the diagnostic accuracy of EUS-FNB with MOSE vs EUS-FNB alone.
time frame: 12 Months
description: Diagnostic accuracy will be measure
arm group label: non MOSE arm
arm group type: Experimental
description: Three needle passes will be performed for each mass
arm group label: MOSE arm
arm group type: Experimental
description: The endoscopist will perform biopsy until a macroscopic visible core (MVC) will be obtained and specimen will be placed in a container (Container A-MOSE). If the needle passes performed are less than 3 (1 or 2 passes) the specimens acquired in the remnant passes to join standard care of 3 passes, according to ESGE guidelines, will be placed in a second container (Container B).
intervention type: Other
intervention name: MOSE
description: After each pass, the stylet will be introduced into the needle, the material will be released onto a smear slide, and a macroscopic on-site quality evaluation (MOSE) of the specimen will be performed by the endoscopist.
arm group label: MOSE arm
arm group label: non MOSE arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Sponsor
sharing ipd: No