<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/NCT03267966</url>
  </required_header>
  <id_info>
    <org_study_id>NI 01/13</org_study_id>
    <nct_id>NCT03267966</nct_id>
  </id_info>
  <brief_title>Margin Status After Pancreaticoduodenectomy for Cancer</brief_title>
  <official_title>Margin Status After Pancreaticoduodenectomy for Cancer. Results of a Multicentric Prospective Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Campus Bio-Medico University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Humanitas Hospital, Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Azienda Ospedaliero, Universitaria Pisana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University of Silesia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Campus Bio-Medico University</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>
      This multicentric prospective randomized controlled trial (RCT) compares the Leeds Pathology&#xD;
      Protocol (LEEPP) with other &quot;conventional&quot; pathological protocol of PD specimen for&#xD;
      periampullary cancer. Our aims were to evaluate the impact of the protocol and of the&#xD;
      clearance on R1 rate and its prognostic value.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2013</start_date>
  <completion_date type="Actual">June 2019</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>R1 resection rate</measure>
    <time_frame>1 month</time_frame>
    <description>To evaluate difference in terms of R1 resection rates between study groups with 0-mm and 1-mm clearance</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pathological data</measure>
    <time_frame>1 month</time_frame>
    <description>To evaluate differences in pathological results (T status, N status, number of blocks, number of lymphnodes, etc) between the two study groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oncological results</measure>
    <time_frame>60 months</time_frame>
    <description>To evaluate the correlation between R1 resection and oncological results (local recurrence, overall survival) in the two study groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">168</enrollment>
  <condition>Pancreatic Cancer</condition>
  <condition>Cholangiocarcinoma</condition>
  <condition>Ampullary Cancer</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Leeds Pathology Protocol (LEEPP)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>&quot;Conventional&quot; method of pathological evaluation</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Leeds Pathology Protocol (LEEPP)</intervention_name>
    <description>LEEPP includes: 1) multicolor inking; 2) axial slicing; 3) circumferential margin; 4) 1-mm clearance</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pancreaticoduodenectomy for periampullary cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diagnosis of neuroendocrine neoplasm;&#xD;
&#xD;
          -  previous pancreatic surgery;&#xD;
&#xD;
          -  frozen section of each transection margins not performed or presence of positive&#xD;
             transection margins without further resection (R1 intraoperative resection);&#xD;
&#xD;
          -  presence of macroscopic residual tumor (R2 resection).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>February 5, 2020</last_update_submitted>
  <last_update_submitted_qc>February 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Campus Bio-Medico University</investigator_affiliation>
    <investigator_full_name>Gennaro Nappo</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>periampullary cancer</keyword>
  <keyword>margin status</keyword>
  <keyword>R1 resection</keyword>
  <keyword>clearance margin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangiocarcinoma</mesh_term>
  </condition_browse>
  <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/NCT03267966
org study id: NI 01/13
nct id: NCT03267966
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This multicentric prospective randomized controlled trial (RCT) compares the Leeds Pathology
      Protocol (LEEPP) with other "conventional" pathological protocol of PD specimen for
      periampullary cancer. Our aims were to evaluate the impact of the protocol and of the
      clearance on R1 rate and its prognostic value.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: R1 resection rate
time frame: 1 month
description: To evaluate difference in terms of R1 resection rates between study groups with 0-mm and 1-mm clearance
measure: pathological data
time frame: 1 month
description: To evaluate differences in pathological results (T status, N status, number of blocks, number of lymphnodes, etc) between the two study groups
measure: oncological results
time frame: 60 months
description: To evaluate the correlation between R1 resection and oncological results (local recurrence, overall survival) in the two study groups
arm group label: Group A
arm group type: Experimental
description: Leeds Pathology Protocol (LEEPP)
arm group label: Group B
arm group type: No Intervention
description: "Conventional" method of pathological evaluation
intervention type: Diagnostic Test
intervention name: Leeds Pathology Protocol (LEEPP)
description: LEEPP includes: 1) multicolor inking; 2) axial slicing; 3) circumferential margin; 4) 1-mm clearance
arm group label: Group A
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Campus Bio-Medico University
investigator full name: Gennaro Nappo
investigator title: M.D.
mesh term: Cholangiocarcinoma
sharing ipd: No