<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/NCT02246322</url>
  </required_header>
  <id_info>
    <org_study_id>BNX-1</org_study_id>
    <nct_id>NCT02246322</nct_id>
  </id_info>
  <brief_title>A Clinical Trial With a New Needle Device Comparing Two Needles for EUS_FNA of Solid Lesions.</brief_title>
  <acronym>EUS-FNA</acronym>
  <official_title>A Randomized Clinical Trial With a New Needle Device Comparing 25G and 22G Needle in Endoscopic Ultrasound Fine-needle Aspiration of Solid Lesions.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Clinico Humanitas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto Clinico Humanitas</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe, and&#xD;
      effective technique for obtaining samples from the GI wall lesions and from organs adjacent&#xD;
      to the GI tract (pancreas, nodes...).Needles available for EUS-FNA include 25G, 22G and 19G.&#xD;
      Some studies have suggested that the 25G needle could be equal or even better than the 22G&#xD;
      needle.&#xD;
&#xD;
      The BXN system and neddles are is a newly developed for EUS-FNA. This trial is developed for&#xD;
      testing the accuracy of the new neddle system for EUS-FNA and for comparing the two needles&#xD;
      types, 25G and 22G.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2013</start_date>
  <completion_date type="Anticipated">November 2014</completion_date>
  <primary_completion_date type="Anticipated">October 2014</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical performance of 22G and 25G needles</measure>
    <time_frame>18 months</time_frame>
    <description>Evaluation of whether enough material for adequate cytological/histological analysis can obtained with equal efficacy with the 25G and the 22G needles. The percentages of adequate samples obtained.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ease of needle pass</measure>
    <time_frame>18 months</time_frame>
    <description>The subjective evaluation of the operator (easy or hard)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Needle malfunction</measure>
    <time_frame>18 months</time_frame>
    <description>Needles do not come out of the cover; kinking; needles do not puncture the tissue (presence or absence of malfunction, and registering of the specific malfunction)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of passes</measure>
    <time_frame>18 months</time_frame>
    <description>The total number of passes needed to obtain adequate material for each lesion (absolute number).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of crossovers</measure>
    <time_frame>18 months</time_frame>
    <description>The times when the need for passage from the 22G to the 25G needle, or vice versa, registered as percentages of the total procedures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major complications</measure>
    <time_frame>18 months</time_frame>
    <description>Bleeding (minor: visible at EUS but without clinical significance or less than 2 g/dl; major: dropping of more than 2 g/dl in Hb levels and clinically significant), perforation (presence/absence), infection (need for hospitalization).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">144</enrollment>
  <condition>Pancreatic Cancer</condition>
  <condition>Neuroendocrine Tumors</condition>
  <condition>Lymphadenopathies</condition>
  <condition>GIST</condition>
  <condition>Gastric Wall Tumor</condition>
  <arm_group>
    <arm_group_label>25G needle</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>22G needle</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>25G needle</intervention_name>
    <description>All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).</description>
    <arm_group_label>25G needle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>22G needle</intervention_name>
    <description>All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).</description>
    <arm_group_label>22G needle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  endosonographic appearance of a solid lesions&#xD;
&#xD;
          -  age &gt;18 years&#xD;
&#xD;
          -  informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  alteration of the coagulation (INR &gt;1.5, PLT &lt;50 x 103 /µL)&#xD;
&#xD;
          -  inability to express consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Silvia Carrara, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Humanitas Research Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Silvia Carrara, MD</last_name>
    <phone>+390282247288</phone>
    <email>silvia.carrara@humanitas.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Humanitas Research Hospital</name>
      <address>
        <city>Rozzano, Milan</city>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alessandro Repici, MD</last_name>
      <phone>+390282247493</phone>
      <email>alessadro.repici@humanitas.it</email>
    </contact>
    <investigator>
      <last_name>Silvia Carrara, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Camellini L, Carlinfante G, Azzolini F, Iori V, Cavina M, Sereni G, Decembrino F, Gallo C, Tamagnini I, Valli R, Piana S, Campari C, Gardini G, Sassatelli R. A randomized clinical trial comparing 22G and 25G needles in endoscopic ultrasound-guided fine-needle aspiration of solid lesions. Endoscopy. 2011 Aug;43(8):709-15. doi: 10.1055/s-0030-1256482. Epub 2011 May 24.</citation>
    <PMID>21611946</PMID>
  </reference>
  <reference>
    <citation>Siddiqui UD, Rossi F, Rosenthal LS, Padda MS, Murali-Dharan V, Aslanian HR. EUS-guided FNA of solid pancreatic masses: a prospective, randomized trial comparing 22-gauge and 25-gauge needles. Gastrointest Endosc. 2009 Dec;70(6):1093-7. doi: 10.1016/j.gie.2009.05.037. Epub 2009 Jul 28.</citation>
    <PMID>19640524</PMID>
  </reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>September 18, 2014</last_update_submitted>
  <last_update_submitted_qc>September 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istituto Clinico Humanitas</investigator_affiliation>
    <investigator_full_name>Michele Tedeschi</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Pancreatic cancer</keyword>
  <keyword>Neuroendocrine tumors</keyword>
  <keyword>Lymphadenopathies</keyword>
  <keyword>GIST</keyword>
  <keyword>Gastrointestinal wall neoplasia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Neuroendocrine Tumors</mesh_term>
    <mesh_term>Lymphadenopathy</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/NCT02246322
org study id: BNX-1
nct id: NCT02246322
lead sponsor: 
has dmc: Yes
Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe, and
      effective technique for obtaining samples from the GI wall lesions and from organs adjacent
      to the GI tract (pancreas, nodes...).Needles available for EUS-FNA include 25G, 22G and 19G.
      Some studies have suggested that the 25G needle could be equal or even better than the 22G
      needle.

      The BXN system and neddles are is a newly developed for EUS-FNA. This trial is developed for
      testing the accuracy of the new neddle system for EUS-FNA and for comparing the two needles
      types, 25G and 22G.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Clinical performance of 22G and 25G needles
time frame: 18 months
description: Evaluation of whether enough material for adequate cytological/histological analysis can obtained with equal efficacy with the 25G and the 22G needles. The percentages of adequate samples obtained.
measure: Ease of needle pass
time frame: 18 months
description: The subjective evaluation of the operator (easy or hard)
measure: Needle malfunction
time frame: 18 months
description: Needles do not come out of the cover; kinking; needles do not puncture the tissue (presence or absence of malfunction, and registering of the specific malfunction)
measure: Number of passes
time frame: 18 months
description: The total number of passes needed to obtain adequate material for each lesion (absolute number).
measure: Number of crossovers
time frame: 18 months
description: The times when the need for passage from the 22G to the 25G needle, or vice versa, registered as percentages of the total procedures.
measure: Major complications
time frame: 18 months
description: Bleeding (minor: visible at EUS but without clinical significance or less than 2 g/dl; major: dropping of more than 2 g/dl in Hb levels and clinically significant), perforation (presence/absence), infection (need for hospitalization).
arm group label: 25G needle
arm group type: Experimental
description: All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).
arm group label: 22G needle
arm group type: Experimental
description: All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).
intervention type: Device
intervention name: 25G needle
description: All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).
arm group label: 25G needle
intervention type: Device
intervention name: 22G needle
description: All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).
arm group label: 22G needle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Silvia Carrara, MD
role: Principal Investigator
affiliation: Humanitas Research Hospital
last name: Silvia Carrara, MD
phone: +390282247288
email: silvia.carrara@humanitas.it
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
citation: Camellini L, Carlinfante G, Azzolini F, Iori V, Cavina M, Sereni G, Decembrino F, Gallo C, Tamagnini I, Valli R, Piana S, Campari C, Gardini G, Sassatelli R. A randomized clinical trial comparing 22G and 25G needles in endoscopic ultrasound-guided fine-needle aspiration of solid lesions. Endoscopy. 2011 Aug;43(8):709-15. doi: 10.1055/s-0030-1256482. Epub 2011 May 24.
PMID: 21611946
citation: Siddiqui UD, Rossi F, Rosenthal LS, Padda MS, Murali-Dharan V, Aslanian HR. EUS-guided FNA of solid pancreatic masses: a prospective, randomized trial comparing 22-gauge and 25-gauge needles. Gastrointest Endosc. 2009 Dec;70(6):1093-7. doi: 10.1016/j.gie.2009.05.037. Epub 2009 Jul 28.
PMID: 19640524
responsible party type: Principal Investigator
investigator affiliation: Istituto Clinico Humanitas
investigator full name: Michele Tedeschi
investigator title: MD
mesh term: Pancreatic Neoplasms
mesh term: Neuroendocrine Tumors
mesh term: Lymphadenopathy