<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/NCT04455737</url>
  </required_header>
  <id_info>
    <org_study_id>Chir202001</org_study_id>
    <secondary_id>2020-01324</secondary_id>
    <nct_id>NCT04455737</nct_id>
  </id_info>
  <brief_title>Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision</brief_title>
  <acronym>RLF</acronym>
  <official_title>Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Walter Brunner</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cantonal Hospital of St. Gallen</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>
      Background: An exact lymph node staging is essential in the treatment of rectal cancer.&#xD;
&#xD;
      Objective: The aim of this study was to assess the effect of indigo carmine injection on the&#xD;
      number of retrieved and positive lymph nodes after transanal total mesorectal excision&#xD;
      (taTME).&#xD;
&#xD;
      Design: This is a retrospective, non-randomised study. Settings: This study was conducted at&#xD;
      a tertiary hospital by a multidisciplinary team.&#xD;
&#xD;
      Patients: Between 2013 and 2019, patients undergoing transanal total mesorectal excision were&#xD;
      analysed. Patients with indigo carmine injection (intervention group) were compared to those&#xD;
      without (control group).&#xD;
&#xD;
      Interventions: Transanal total mesorectal excision was performed with or without ex vivo&#xD;
      intra-arterial indigo carmine injection.&#xD;
&#xD;
      Main Outcome Measures: The number of retrieved and positive lymph nodes was the primary&#xD;
      outcome measure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2013</start_date>
  <completion_date type="Actual">June 2020</completion_date>
  <primary_completion_date type="Actual">December 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>retrieved lymph nodes</measure>
    <time_frame>1 - 7 days after surgery</time_frame>
    <description>number of lymph nodes retrieved by pathologist from the specimen</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>positive lymph nodes</measure>
    <time_frame>1 - 7 days after surgery</time_frame>
    <description>number of lymph nodes with microscopic tumor infiltration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>N stage</measure>
    <time_frame>1 - 7 days after surgery</time_frame>
    <description>N stage according TNM version 7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>survival</measure>
    <time_frame>5 years</time_frame>
    <description>overall survival</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">189</enrollment>
  <condition>Rectal Neoplasms</condition>
  <arm_group>
    <arm_group_label>Patients with indigo carmine stained specimen</arm_group_label>
    <description>Specimen which underwent pathologic work-up after ex vivo indigo carmine injection into the inferior mesenteric artery after transanal total mesorectal excision.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with unstained specimen</arm_group_label>
    <description>Specimen which underwent pathologic work-up after transanal total mesorectal excision without indigo carmine dyeing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>injection of indigo carmine</intervention_name>
    <description>Ex vivo intra-arterial injection of 20 ml indigo carmine solution (10mL, 0.4% indigo carmine with 10mL, 0.9% saline solution) in the transanal total mesorectal excision specimen via the inferior mesenteric artery.</description>
    <arm_group_label>Patients with indigo carmine stained specimen</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing elective, oncologic rectum resection in TaTME technique&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective, oncologic rectum resection in TaTME technique for proven or highly suspected&#xD;
             rectal cancer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  abdominoperineal resection&#xD;
&#xD;
          -  extended colon resection&#xD;
&#xD;
          -  previous surgery of the rectum, the left colon or the mesocolon/-rectum&#xD;
&#xD;
          -  patients rejecting retrospective data analysis&#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>Walter Brunner, MD MSc MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kantonsspital St. Gallen, Rorschach branch, Department of Surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen</name>
      <address>
        <city>Rorschach</city>
        <zip>9400</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>August 3, 2021</last_update_submitted>
  <last_update_submitted_qc>August 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cantonal Hospital of St. Gallen</investigator_affiliation>
    <investigator_full_name>Walter Brunner</investigator_full_name>
    <investigator_title>Senior Consultant</investigator_title>
  </responsible_party>
  <keyword>indigo carmine</keyword>
  <keyword>lymph node</keyword>
  <keyword>pathology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</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/NCT04455737
org study id: Chir202001
secondary id: 2020-01324
nct id: NCT04455737
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: An exact lymph node staging is essential in the treatment of rectal cancer.

      Objective: The aim of this study was to assess the effect of indigo carmine injection on the
      number of retrieved and positive lymph nodes after transanal total mesorectal excision
      (taTME).

      Design: This is a retrospective, non-randomised study. Settings: This study was conducted at
      a tertiary hospital by a multidisciplinary team.

      Patients: Between 2013 and 2019, patients undergoing transanal total mesorectal excision were
      analysed. Patients with indigo carmine injection (intervention group) were compared to those
      without (control group).

      Interventions: Transanal total mesorectal excision was performed with or without ex vivo
      intra-arterial indigo carmine injection.

      Main Outcome Measures: The number of retrieved and positive lymph nodes was the primary
      outcome measure.
observational model: Cohort
time perspective: Retrospective
measure: retrieved lymph nodes
time frame: 1 - 7 days after surgery
description: number of lymph nodes retrieved by pathologist from the specimen
measure: positive lymph nodes
time frame: 1 - 7 days after surgery
description: number of lymph nodes with microscopic tumor infiltration
measure: N stage
time frame: 1 - 7 days after surgery
description: N stage according TNM version 7
measure: survival
time frame: 5 years
description: overall survival
arm group label: Patients with indigo carmine stained specimen
description: Specimen which underwent pathologic work-up after ex vivo indigo carmine injection into the inferior mesenteric artery after transanal total mesorectal excision.
arm group label: Patients with unstained specimen
description: Specimen which underwent pathologic work-up after transanal total mesorectal excision without indigo carmine dyeing.
intervention type: Other
intervention name: injection of indigo carmine
description: Ex vivo intra-arterial injection of 20 ml indigo carmine solution (10mL, 0.4% indigo carmine with 10mL, 0.9% saline solution) in the transanal total mesorectal excision specimen via the inferior mesenteric artery.
arm group label: Patients with indigo carmine stained specimen
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Walter Brunner, MD MSc MBA
role: Principal Investigator
affiliation: Kantonsspital St. Gallen, Rorschach branch, Department of Surgery
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: Cantonal Hospital of St. Gallen
investigator full name: Walter Brunner
investigator title: Senior Consultant
mesh term: Rectal Neoplasms
sharing ipd: No