<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/NCT03017599</url>
  </required_header>
  <id_info>
    <org_study_id>4-2016-0429</org_study_id>
    <nct_id>NCT03017599</nct_id>
  </id_info>
  <brief_title>Yield Rate for Procurement the Histologic Core With Endoscopic Ultrasound-guided Fine Needle Biopsy With 20-gauge Ultrasound Biopsy Needles for Solid Pancreatic Masses: Pilot Study</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the technical feasibility and diagnostic yield of new 20-gauge Procore needle&#xD;
      for EUS-guided fine needle biopsy in pancreatic solid lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. Surgery&#xD;
      remains the only treatment offering an advantage in terms of overall survival (5-year&#xD;
      survival range, 15-25%), but unfortunately only 10-20% of patients present resectable disease&#xD;
      at the time of diagnosis.&#xD;
&#xD;
      Regarding the diagnosis of pancreatic cancer, proper tool with high diagnostic yield is very&#xD;
      important. The investigators investigated the technical feasibility and diagnostic yield of&#xD;
      recent-developed new 20-gauge Procore needle for EUS-guided fine needle biopsy in pancreatic&#xD;
      solid lesions.&#xD;
&#xD;
      The investigators applied the 20-gauge procore needle for EUS-guided fine needle biopsy in&#xD;
      the diagnosis of pancreatic solid mass. A total of 30 patients will be enrolled for the&#xD;
      present pilot study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 11, 2016</start_date>
  <completion_date type="Actual">July 10, 2017</completion_date>
  <primary_completion_date type="Actual">July 10, 2017</primary_completion_date>
  <phase>N/A</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>Procurement of the histologic core</measure>
    <time_frame>7 days after the procedure</time_frame>
    <description>The sample quality is evaluated as optimal for histological evaluation; the presence of optimal histological core including recognizable structures</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnostic accuracy</measure>
    <time_frame>7 days after the procedure</time_frame>
    <description>[Standard diagnosis]&#xD;
In operated patients; based on the surgical resection specimen&#xD;
In non-operated patients; based on the conclusions of the diagnostic work-up and confirmed by a compatible clinical disease course</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical success</measure>
    <time_frame>7 days after the procedure</time_frame>
    <description>Technical failure is defined as malfunction of the needle before the investigators reached a diagnosis</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Pancreatic Cancer</condition>
  <condition>Solid Pancreatic and Peripancreatic Lesion</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EUS-FNB using 20-gauge procore needle</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>20-gauge ProCore FNB needle</intervention_name>
    <description>The investigators will prospectively collect data base including patients who underwent EUS-guided biopsy with the 20-gauge ProCore histology needle for the evaluation of Pancreatic solid mass.&#xD;
EUS procedures will be performed under sedation with linear echoendoscopes. Once the lesion will be penetrated, the stylet will be removed, and suction will be applied for 10 to 20 seconds by using a 10-ml syringe while moving the needle to and fro. All samples will processed at the pathology departments for histological analysis with documentation.</description>
    <arm_group_label>Intervention group</arm_group_label>
    <other_name>20G Echotip ProCore Fine Needle Biopsy (FNB) device(Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who are at least 20 years of age&#xD;
&#xD;
          -  patients who require endoscopic ultrasound-guided fine needle aspiration cytology or&#xD;
             biopsy because of pancreatic or peripancreatic solid mass.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cystic pancreatic mass in imaging tests such as CT or MRI or US&#xD;
&#xD;
          -  haemodynamically unstable patients&#xD;
&#xD;
          -  severe coagulopathy (international normalized ratio [INR] &gt; 1.5 or platelet count &lt;&#xD;
             50,000 cells/cubic millimeter [cmm3])&#xD;
&#xD;
          -  patients unable to quit anticoagulant/anti-platelet therapy&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Lee JH, Stewart J, Ross WA, Anandasabapathy S, Xiao L, Staerkel G. Blinded prospective comparison of the performance of 22-gauge and 25-gauge needles in endoscopic ultrasound-guided fine needle aspiration of the pancreas and peri-pancreatic lesions. Dig Dis Sci. 2009 Oct;54(10):2274-81. doi: 10.1007/s10620-009-0906-1. Epub 2009 Aug 11.</citation>
    <PMID>19669880</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>May 2018</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>May 17, 2018</last_update_submitted>
  <last_update_submitted_qc>May 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2018</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/NCT03017599
org study id: 4-2016-0429
nct id: NCT03017599
lead sponsor: 
has dmc: No
To investigate the technical feasibility and diagnostic yield of new 20-gauge Procore needle
      for EUS-guided fine needle biopsy in pancreatic solid lesions.
Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. Surgery
      remains the only treatment offering an advantage in terms of overall survival (5-year
      survival range, 15-25%), but unfortunately only 10-20% of patients present resectable disease
      at the time of diagnosis.

      Regarding the diagnosis of pancreatic cancer, proper tool with high diagnostic yield is very
      important. The investigators investigated the technical feasibility and diagnostic yield of
      recent-developed new 20-gauge Procore needle for EUS-guided fine needle biopsy in pancreatic
      solid lesions.

      The investigators applied the 20-gauge procore needle for EUS-guided fine needle biopsy in
      the diagnosis of pancreatic solid mass. A total of 30 patients will be enrolled for the
      present pilot study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Procurement of the histologic core
time frame: 7 days after the procedure
description: The sample quality is evaluated as optimal for histological evaluation; the presence of optimal histological core including recognizable structures
measure: Diagnostic accuracy
time frame: 7 days after the procedure
description: [Standard diagnosis]
In operated patients; based on the surgical resection specimen
In non-operated patients; based on the conclusions of the diagnostic work-up and confirmed by a compatible clinical disease course
measure: Technical success
time frame: 7 days after the procedure
description: Technical failure is defined as malfunction of the needle before the investigators reached a diagnosis
arm group label: Intervention group
arm group type: Experimental
description: EUS-FNB using 20-gauge procore needle
intervention type: Device
intervention name: 20-gauge ProCore FNB needle
description: The investigators will prospectively collect data base including patients who underwent EUS-guided biopsy with the 20-gauge ProCore histology needle for the evaluation of Pancreatic solid mass.
EUS procedures will be performed under sedation with linear echoendoscopes. Once the lesion will be penetrated, the stylet will be removed, and suction will be applied for 10 to 20 seconds by using a 10-ml syringe while moving the needle to and fro. All samples will processed at the pathology departments for histological analysis with documentation.
arm group label: Intervention group
other name: 20G Echotip ProCore Fine Needle Biopsy (FNB) device(Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
citation: Lee JH, Stewart J, Ross WA, Anandasabapathy S, Xiao L, Staerkel G. Blinded prospective comparison of the performance of 22-gauge and 25-gauge needles in endoscopic ultrasound-guided fine needle aspiration of the pancreas and peri-pancreatic lesions. Dig Dis Sci. 2009 Oct;54(10):2274-81. doi: 10.1007/s10620-009-0906-1. Epub 2009 Aug 11.
PMID: 19669880
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: Sponsor
sharing ipd: No