<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/NCT04444934</url>
  </required_header>
  <id_info>
    <org_study_id>DIPUSVSP-03-02-2033</org_study_id>
    <nct_id>NCT04444934</nct_id>
  </id_info>
  <brief_title>Intra-operative Visual Examination at IDS</brief_title>
  <acronym>VIPER</acronym>
  <official_title>Can Intraoperative Visual Examination of Diaphragmatic Peritoneum be a Reliable Tool to Modulate the Extent of Interval Debulking Surgery in Advanced Ovarian Cancer? The VIPER (VIsual Peritoneal Evaluation of Residual Disease) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Catholic University of the Sacred Heart</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Catholic University of the Sacred Heart</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>
      Complete disease removal has the greatest impact in the treatment of advanced ovarian cancer,&#xD;
      both during primary debulking surgery (PDS) and interval debulking surgery (IDS), but,&#xD;
      contrarily to PDS, no consensus exist on the interpretation of the absence of residual tumor&#xD;
      at IDS. In addition, chemotherapy induces fibrotic changes that can hinder the surgeon's&#xD;
      ability to properly assess the spread of abdominal disease. The aim of the study is to&#xD;
      evaluate the accuracy of visual inspection compared to histopathological examination at the&#xD;
      level of the diaphragmatic peritoneum in patients undergoing surgery after neoadjuvant&#xD;
      chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All data of patients subjected to IDS between October 2016 and October 2019 with evidence of&#xD;
      suspected or certain residual disease at the level of the right diaphragmatic peritoneum, at&#xD;
      intra-operative evaluation have been collected. Diaphragmatic peritoneum was classified as&#xD;
      negative, not-surely pathologic and certainly pathologic by the surgeon, and based on the&#xD;
      surgeon's opinion, a diaphragmatic biopsy or peritonectomy was then performed. The definition&#xD;
      of not-surely pathologic diaphragmatic peritoneum was given in association with the presence&#xD;
      of flat dyschromic areas, while the definition of certainly pathological diaphragmatic&#xD;
      peritoneum was given when isolated or confluent thick nodules were visualized at the&#xD;
      intra-operative inspection. Residual disease was indicated at the end of each intervention&#xD;
      and classified as no residual disease (RD=0, complete cytoreduction), less than 1 centimeter&#xD;
      (RD &lt;/= 1 cm, optimal cytoreduction) or more than 1 cm (RD &gt; 1 cm, sub-optimal&#xD;
      cytoreduction).&#xD;
&#xD;
      Pathological specimens' results were also divided in negative (no evidence of disease),&#xD;
      microscopic evidence of residual disease (&lt;/= 3 mm) or macroscopic signs of residual disease&#xD;
      (&gt; 3 mm). Microscopic and macroscopic disease were both considered as positive for residual&#xD;
      disease.&#xD;
&#xD;
      General early post-operative complications (arising within 30 days from surgery), and&#xD;
      complications related to diaphragmatic peritonectomy, as post-operative pleural effusion,&#xD;
      were classified using the extended Clavien-Dindo classification of surgical complications.&#xD;
&#xD;
      The primary end-point of the study was to evaluate the accuracy, sensitivity and specificity&#xD;
      of the visual inspection compared to histopathological examination, at the level of the right&#xD;
      diaphragmatic peritoneum, in patients subjected to IDS.&#xD;
&#xD;
      The secondary endpoints were to evaluate the rate of early postoperative complications&#xD;
      related to diaphragmatic peritonectomy and assess whether this procedure may delay the&#xD;
      re-start of post-operative chemotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">October 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy</measure>
    <time_frame>During surgery</time_frame>
    <description>to evaluate the accuracy of the visual examination compared to histopathological examination, at the level of the right diaphragmatic peritoneum, in patients subjected to IDS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-operative complications</measure>
    <time_frame>up to 30 days after surgery</time_frame>
    <description>to evaluate the rate of early postoperative complications related to diaphragmatic peritonectomy</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">155</enrollment>
  <condition>Diaphragm Disease</condition>
  <arm_group>
    <arm_group_label>Patients with not-surely pathologic diaphragmatic peritoneum</arm_group_label>
    <description>The definition of not-surely pathologic diaphragmatic peritoneum was given in association with the presence of flat dyschromic areas.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with certainly pathologic diaphragmatic peritoneum</arm_group_label>
    <description>The definition of certainly pathological diaphragmatic peritoneum was given when isolated or confluent thick nodules were visualized at the intra-operative inspection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>histological examination</intervention_name>
    <description>Patients were classified in two groups based on the surgeon's visual examination of the right diaphragmatic peritoneum. The accuracy of visual examination has been assessed comparing surgeon's opinions to histological examination</description>
    <arm_group_label>Patients with certainly pathologic diaphragmatic peritoneum</arm_group_label>
    <arm_group_label>Patients with not-surely pathologic diaphragmatic peritoneum</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with histology proven biopsy of epithelial ovarian, fallopian or peritoneal cancer&#xD;
        (FIGO stage III C - IV B), judged suitable for IDS by clinicians, with evidence of&#xD;
        suspected or certain residual disease at the level of the right diaphragmatic peritoneum,&#xD;
        at intraoperative evaluation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with histology proven biopsy of epithelial ovarian, fallopian or peritoneal&#xD;
             cancer (FIGO stage III C - IV B), judged suitable for IDS by clinicians, with evidence&#xD;
             of suspected or certain residual disease at the level of the right diaphragmatic&#xD;
             peritoneum, at intraoperative evaluation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with no evidence of diaphragmatic disease during IDS, and who therefore did&#xD;
             not undergo diaphragmatic peritonectomy or biopsy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barbara Costantini, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario A. Gemelli, IRCCS</name>
      <address>
        <city>Rome</city>
        <state>RM</state>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Catholic University of the Sacred Heart</investigator_affiliation>
    <investigator_full_name>Prof. Giovanni Scambia</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>ovarian cancer</keyword>
  <keyword>interval debulking surgery</keyword>
  <keyword>visual examination</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04444934
org study id: DIPUSVSP-03-02-2033
nct id: NCT04444934
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Complete disease removal has the greatest impact in the treatment of advanced ovarian cancer,
      both during primary debulking surgery (PDS) and interval debulking surgery (IDS), but,
      contrarily to PDS, no consensus exist on the interpretation of the absence of residual tumor
      at IDS. In addition, chemotherapy induces fibrotic changes that can hinder the surgeon's
      ability to properly assess the spread of abdominal disease. The aim of the study is to
      evaluate the accuracy of visual inspection compared to histopathological examination at the
      level of the diaphragmatic peritoneum in patients undergoing surgery after neoadjuvant
      chemotherapy.
All data of patients subjected to IDS between October 2016 and October 2019 with evidence of
      suspected or certain residual disease at the level of the right diaphragmatic peritoneum, at
      intra-operative evaluation have been collected. Diaphragmatic peritoneum was classified as
      negative, not-surely pathologic and certainly pathologic by the surgeon, and based on the
      surgeon's opinion, a diaphragmatic biopsy or peritonectomy was then performed. The definition
      of not-surely pathologic diaphragmatic peritoneum was given in association with the presence
      of flat dyschromic areas, while the definition of certainly pathological diaphragmatic
      peritoneum was given when isolated or confluent thick nodules were visualized at the
      intra-operative inspection. Residual disease was indicated at the end of each intervention
      and classified as no residual disease (RD=0, complete cytoreduction), less than 1 centimeter
      (RD </= 1 cm, optimal cytoreduction) or more than 1 cm (RD > 1 cm, sub-optimal
      cytoreduction).

      Pathological specimens' results were also divided in negative (no evidence of disease),
      microscopic evidence of residual disease (</= 3 mm) or macroscopic signs of residual disease
      (> 3 mm). Microscopic and macroscopic disease were both considered as positive for residual
      disease.

      General early post-operative complications (arising within 30 days from surgery), and
      complications related to diaphragmatic peritonectomy, as post-operative pleural effusion,
      were classified using the extended Clavien-Dindo classification of surgical complications.

      The primary end-point of the study was to evaluate the accuracy, sensitivity and specificity
      of the visual inspection compared to histopathological examination, at the level of the right
      diaphragmatic peritoneum, in patients subjected to IDS.

      The secondary endpoints were to evaluate the rate of early postoperative complications
      related to diaphragmatic peritonectomy and assess whether this procedure may delay the
      re-start of post-operative chemotherapy.
observational model: Cohort
time perspective: Retrospective
measure: Accuracy
time frame: During surgery
description: to evaluate the accuracy of the visual examination compared to histopathological examination, at the level of the right diaphragmatic peritoneum, in patients subjected to IDS
measure: Post-operative complications
time frame: up to 30 days after surgery
description: to evaluate the rate of early postoperative complications related to diaphragmatic peritonectomy
arm group label: Patients with not-surely pathologic diaphragmatic peritoneum
description: The definition of not-surely pathologic diaphragmatic peritoneum was given in association with the presence of flat dyschromic areas.
arm group label: Patients with certainly pathologic diaphragmatic peritoneum
description: The definition of certainly pathological diaphragmatic peritoneum was given when isolated or confluent thick nodules were visualized at the intra-operative inspection.
intervention type: Other
intervention name: histological examination
description: Patients were classified in two groups based on the surgeon's visual examination of the right diaphragmatic peritoneum. The accuracy of visual examination has been assessed comparing surgeon's opinions to histological examination
arm group label: Patients with certainly pathologic diaphragmatic peritoneum
arm group label: Patients with not-surely pathologic diaphragmatic peritoneum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Barbara Costantini, MD
role: Principal Investigator
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Catholic University of the Sacred Heart
investigator full name: Prof. Giovanni Scambia
investigator title: Professor
sharing ipd: Undecided