<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/NCT03016637</url>
  </required_header>
  <id_info>
    <org_study_id>MBM-71</org_study_id>
    <nct_id>NCT03016637</nct_id>
  </id_info>
  <brief_title>Pancreatic Core Biopsy Needle Study in Patients Suspected of Pancreatic Malignancy</brief_title>
  <acronym>PANCOBE</acronym>
  <official_title>Pancreatic Core Biopsy Needle Study (PANCOBE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates whether a new endoscopic ultrasonography (EUS) histology needle may&#xD;
      improve the diagnostic yield during biopsies of pancreatic lesions&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pancreatic cancer has a poor prognosis, and a quick and correct diagnosis is essential.&#xD;
      Endoscopic ultrasonography (EUS) is highly accurate regarding the detection of pancreatic&#xD;
      cancer, and EUS guided fine-needle aspiration biopsy (EUS-FNA) may be used to verify the&#xD;
      diagnosis in patients with non-resectable or metastatic disease. However, EUS-FNA is only&#xD;
      diagnostic in approximately 70% of the cases, and the reported number of &quot;atypical&quot;,&#xD;
      &quot;suspicious&quot; and &quot;insufficient&quot; biopsies varies.&#xD;
&#xD;
      SharkCore (TM) is a new type of EUS fine needle that allows the extraction of macroscopic&#xD;
      tissue fractions (&quot;trucut biopsies&quot;) instead of single cells or cluster of cells. Preliminary&#xD;
      data suggest that EUS guided trucut biopsies from the pancreatic lesions are technically&#xD;
      feasible without increasing the number of complications.&#xD;
&#xD;
      This prospective study evaluates the clinical outcome and potential complications following&#xD;
      EUS guided biopsy of pancreatic lesions suspected of cancer using a 25 Gauge or 22 Gauge&#xD;
      SharkCore needle.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of conclusive biopsies</measure>
    <time_frame>minimum 6 moths after biopsy</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>2 weeks after biopsy</time_frame>
    <description>All contacts to the secondary health care system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality test of biopsies</measure>
    <time_frame>2 weeks after biopsy</time_frame>
    <description>Biopsies divided into:&#xD;
1) diagnostic 2a) if not diagnostic - representative material 2b) if not diagnostic - not representative material 3) Insufficient material</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>EUS biopsy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EUS guided SharkCore (TM) biopsy of pancreatic lesions suspected of malignancy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SharkCore (TM) FNB Exchange System</intervention_name>
    <arm_group_label>EUS biopsy</arm_group_label>
    <other_name>25 Gauge or 22 Gauge SharkCore needle</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pancreatic lesion suspected of malignancy and EUS biopsy indicated&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Resectable pancreatic lesions&#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>Michael B Mortensen, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Odense University Hospital, University of Southern denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>Hewitt MJ, McPhail MJ, Possamai L, Dhar A, Vlavianos P, Monahan KJ. EUS-guided FNA for diagnosis of solid pancreatic neoplasms: a meta-analysis. Gastrointest Endosc. 2012 Feb;75(2):319-31. doi: 10.1016/j.gie.2011.08.049.</citation>
    <PMID>22248600</PMID>
  </reference>
  <reference>
    <citation>Bardales RH, Stelow EB, Mallery S, Lai R, Stanley MW. Review of endoscopic ultrasound-guided fine-needle aspiration cytology. Diagn Cytopathol. 2006 Feb;34(2):140-75. doi: 10.1002/dc.20300.</citation>
    <PMID>16511852</PMID>
  </reference>
  <reference>
    <citation>Iglesias-Garcia J, Poley JW, Larghi A, Giovannini M, Petrone MC, Abdulkader I, Monges G, Costamagna G, Arcidiacono P, Biermann K, Rindi G, Bories E, Dogloni C, Bruno M, Dominguez-Munoz JE. Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study. Gastrointest Endosc. 2011 Jun;73(6):1189-96. doi: 10.1016/j.gie.2011.01.053. Epub 2011 Mar 21.</citation>
    <PMID>21420083</PMID>
  </reference>
  <reference>
    <citation>Bang JY, Hebert-Magee S, Trevino J, Ramesh J, Varadarajulu S. Randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2012 Aug;76(2):321-7. doi: 10.1016/j.gie.2012.03.1392. Epub 2012 May 31.</citation>
    <PMID>22658389</PMID>
  </reference>
  <reference>
    <citation>Mortensen MB, Fristrup C, Holm FS, Pless T, Durup J, Ainsworth AP, Nielsen HO, Hovendal C. Prospective evaluation of patient tolerability, satisfaction with patient information, and complications in endoscopic ultrasonography. Endoscopy. 2005 Feb;37(2):146-53. doi: 10.1055/s-2005-861142.</citation>
    <PMID>15692930</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Michael Bau Mortensen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>endoscopic ultrasonography</keyword>
  <keyword>EUS-FNA</keyword>
  <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/NCT03016637
org study id: MBM-71
nct id: NCT03016637
lead sponsor: 
has dmc: No
This study evaluates whether a new endoscopic ultrasonography (EUS) histology needle may
      improve the diagnostic yield during biopsies of pancreatic lesions
Pancreatic cancer has a poor prognosis, and a quick and correct diagnosis is essential.
      Endoscopic ultrasonography (EUS) is highly accurate regarding the detection of pancreatic
      cancer, and EUS guided fine-needle aspiration biopsy (EUS-FNA) may be used to verify the
      diagnosis in patients with non-resectable or metastatic disease. However, EUS-FNA is only
      diagnostic in approximately 70% of the cases, and the reported number of "atypical",
      "suspicious" and "insufficient" biopsies varies.

      SharkCore (TM) is a new type of EUS fine needle that allows the extraction of macroscopic
      tissue fractions ("trucut biopsies") instead of single cells or cluster of cells. Preliminary
      data suggest that EUS guided trucut biopsies from the pancreatic lesions are technically
      feasible without increasing the number of complications.

      This prospective study evaluates the clinical outcome and potential complications following
      EUS guided biopsy of pancreatic lesions suspected of cancer using a 25 Gauge or 22 Gauge
      SharkCore needle.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of conclusive biopsies
time frame: minimum 6 moths after biopsy
measure: Complications
time frame: 2 weeks after biopsy
description: All contacts to the secondary health care system
measure: Quality test of biopsies
time frame: 2 weeks after biopsy
description: Biopsies divided into:
1) diagnostic 2a) if not diagnostic - representative material 2b) if not diagnostic - not representative material 3) Insufficient material
arm group label: EUS biopsy
arm group type: Experimental
description: EUS guided SharkCore (TM) biopsy of pancreatic lesions suspected of malignancy
intervention type: Device
intervention name: SharkCore (TM) FNB Exchange System
arm group label: EUS biopsy
other name: 25 Gauge or 22 Gauge SharkCore needle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael B Mortensen, Professor
role: Study Director
affiliation: Odense University Hospital, University of Southern denmark
facility: 
country: Denmark
citation: Hewitt MJ, McPhail MJ, Possamai L, Dhar A, Vlavianos P, Monahan KJ. EUS-guided FNA for diagnosis of solid pancreatic neoplasms: a meta-analysis. Gastrointest Endosc. 2012 Feb;75(2):319-31. doi: 10.1016/j.gie.2011.08.049.
PMID: 22248600
citation: Bardales RH, Stelow EB, Mallery S, Lai R, Stanley MW. Review of endoscopic ultrasound-guided fine-needle aspiration cytology. Diagn Cytopathol. 2006 Feb;34(2):140-75. doi: 10.1002/dc.20300.
PMID: 16511852
citation: Iglesias-Garcia J, Poley JW, Larghi A, Giovannini M, Petrone MC, Abdulkader I, Monges G, Costamagna G, Arcidiacono P, Biermann K, Rindi G, Bories E, Dogloni C, Bruno M, Dominguez-Munoz JE. Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study. Gastrointest Endosc. 2011 Jun;73(6):1189-96. doi: 10.1016/j.gie.2011.01.053. Epub 2011 Mar 21.
PMID: 21420083
citation: Bang JY, Hebert-Magee S, Trevino J, Ramesh J, Varadarajulu S. Randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2012 Aug;76(2):321-7. doi: 10.1016/j.gie.2012.03.1392. Epub 2012 May 31.
PMID: 22658389
citation: Mortensen MB, Fristrup C, Holm FS, Pless T, Durup J, Ainsworth AP, Nielsen HO, Hovendal C. Prospective evaluation of patient tolerability, satisfaction with patient information, and complications in endoscopic ultrasonography. Endoscopy. 2005 Feb;37(2):146-53. doi: 10.1055/s-2005-861142.
PMID: 15692930
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Michael Bau Mortensen
investigator title: Professor
sharing ipd: No