<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/NCT01727921</url>
  </required_header>
  <id_info>
    <org_study_id>2012-08-066-001</org_study_id>
    <nct_id>NCT01727921</nct_id>
  </id_info>
  <brief_title>Comparative Study of 22 and 25 Gauge ProCore EUS-guided Biopsy in Pancreatic Mass</brief_title>
  <official_title>Endoscopic Ultrasound-guided Fine Needle Tissue Acquisition With 22- and 25-gauge ProCore Needle in Solid Pancreatic and Peripancreatic Masses: A Prospective Comparative Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      EUS-guided fine needle aspiration (FNA) is a major diagnostic tool in the patient with&#xD;
      pancreatic mass with high specificity, specificity and accuracy. However FNA with small&#xD;
      needle has sometimes failed in acquisition of tissue due to small caliber. To overcome this&#xD;
      limitation, newly designed ProCore needle was developed and flexible 22 and 25 gauge ProCore&#xD;
      needles were frequently used. However there was no comparative study of the efficacy and&#xD;
      accuracy between 22 and 25 gauge ProCore needle yet.&#xD;
&#xD;
      Aim:&#xD;
&#xD;
      To compare the efficacy and accuracy of EUS-guided FNA between 22 and 25 gauge ProCore&#xD;
      needle. (The investigators hypothesized that the accuracy of 25 gauge Procore needle is not&#xD;
      inferior to 22 gauge ProCore needle.)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient and methods:&#xD;
&#xD;
      Patients who have pancreatic or peripancreatic mass in imaging studies which need pathologic&#xD;
      confirm. These patients were randomly assigned to 22 gauge or 25 gauge group.&#xD;
&#xD;
      Procedure:&#xD;
&#xD;
      They underwent EUS-guided FNA, 3 times with 10 times of to-and pro movement each.&#xD;
&#xD;
      The number of patients required:&#xD;
&#xD;
      We used confidence intervals (CIs) with a prespecified non-inferiority margin of 10% for the&#xD;
      non-inferiority analysis. We concluded non-inferiority of PC25 to PC22 if the lower limit of&#xD;
      the 95% CI for the difference (PC25-PC22) was not lower than -10%. It was assumed that the&#xD;
      diagnostic accuracy of one pass was 75% and that of three cumulative passes was estimated to&#xD;
      be 98.4% in PC22. Based on these assumptions, the calculated sample size was 216 samples with&#xD;
      power of 80% and significance level of 5%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">December 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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic accuracy</measure>
    <time_frame>October. 2014</time_frame>
    <description>Diagnostic accuracy include histologic diAgnosis and cytologic diagnosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical success</measure>
    <time_frame>October. 2014</time_frame>
    <description>Technical success means the gain of tissue or cells through EUS-guided FNA.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Complications</measure>
    <time_frame>November. 2014</time_frame>
    <description>Investigate the occurrence of complications such bleeding and perforation. Not only complications, but the size and location of lesion, puncture routes will be assessed.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">219</enrollment>
  <condition>Pancreatic Neoplasms</condition>
  <arm_group>
    <arm_group_label>22 gauge ProCore needle biopsy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>EUS-guided pancreatic or peripancreatic mass biopsy with 22 gauge ProCore biopsy needle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>25 gauge ProCore needle biopsy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>EUS-guided pancreatic or peripancreatic mass biopsy with 25 gauge ProCore biopsy needle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>22 gauge ProCore needle biopsy</intervention_name>
    <description>22 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle</description>
    <arm_group_label>22 gauge ProCore needle biopsy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>25 gauge ProCore needle biopsy</intervention_name>
    <description>25 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle</description>
    <arm_group_label>25 gauge ProCore needle biopsy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who agree to participate in research&#xD;
&#xD;
          -  18 years of age and older patients&#xD;
&#xD;
          -  Patients who have pancreatic or peripancreatic mass in imaging studies&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to endoscopy&#xD;
&#xD;
          -  Patients younger than 18 years old&#xD;
&#xD;
          -  Bleeding tendency&#xD;
&#xD;
          -  Cardiopulmonary dysfunction&#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>Kwanghyuck Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor of Medicine, Division of Gastroenterology, Samsung Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul City</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>October 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>April 27, 2016</last_update_submitted>
  <last_update_submitted_qc>April 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Kwang Hyuck Lee</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine, Division of Gastroenterology</investigator_title>
  </responsible_party>
  <keyword>ProCore FNA biopsy</keyword>
  <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/NCT01727921
org study id: 2012-08-066-001
nct id: NCT01727921
lead sponsor: 
has dmc: Yes
Background:

      EUS-guided fine needle aspiration (FNA) is a major diagnostic tool in the patient with
      pancreatic mass with high specificity, specificity and accuracy. However FNA with small
      needle has sometimes failed in acquisition of tissue due to small caliber. To overcome this
      limitation, newly designed ProCore needle was developed and flexible 22 and 25 gauge ProCore
      needles were frequently used. However there was no comparative study of the efficacy and
      accuracy between 22 and 25 gauge ProCore needle yet.

      Aim:

      To compare the efficacy and accuracy of EUS-guided FNA between 22 and 25 gauge ProCore
      needle. (The investigators hypothesized that the accuracy of 25 gauge Procore needle is not
      inferior to 22 gauge ProCore needle.)
Patient and methods:

      Patients who have pancreatic or peripancreatic mass in imaging studies which need pathologic
      confirm. These patients were randomly assigned to 22 gauge or 25 gauge group.

      Procedure:

      They underwent EUS-guided FNA, 3 times with 10 times of to-and pro movement each.

      The number of patients required:

      We used confidence intervals (CIs) with a prespecified non-inferiority margin of 10% for the
      non-inferiority analysis. We concluded non-inferiority of PC25 to PC22 if the lower limit of
      the 95% CI for the difference (PC25-PC22) was not lower than -10%. It was assumed that the
      diagnostic accuracy of one pass was 75% and that of three cumulative passes was estimated to
      be 98.4% in PC22. Based on these assumptions, the calculated sample size was 216 samples with
      power of 80% and significance level of 5%.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Participant, Care Provider)
measure: Diagnostic accuracy
time frame: October. 2014
description: Diagnostic accuracy include histologic diAgnosis and cytologic diagnosis
measure: Technical success
time frame: October. 2014
description: Technical success means the gain of tissue or cells through EUS-guided FNA.
measure: Complications
time frame: November. 2014
description: Investigate the occurrence of complications such bleeding and perforation. Not only complications, but the size and location of lesion, puncture routes will be assessed.
arm group label: 22 gauge ProCore needle biopsy
arm group type: Active Comparator
description: EUS-guided pancreatic or peripancreatic mass biopsy with 22 gauge ProCore biopsy needle.
arm group label: 25 gauge ProCore needle biopsy
arm group type: Active Comparator
description: EUS-guided pancreatic or peripancreatic mass biopsy with 25 gauge ProCore biopsy needle.
intervention type: Device
intervention name: 22 gauge ProCore needle biopsy
description: 22 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle
arm group label: 22 gauge ProCore needle biopsy
intervention type: Device
intervention name: 25 gauge ProCore needle biopsy
description: 25 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle
arm group label: 25 gauge ProCore needle biopsy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kwanghyuck Lee, MD
role: Principal Investigator
affiliation: Assistant Professor of Medicine, Division of Gastroenterology, Samsung Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Kwang Hyuck Lee
investigator title: Assistant Professor of Medicine, Division of Gastroenterology
mesh term: Pancreatic Neoplasms