<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/NCT03292757</url>
  </required_header>
  <id_info>
    <org_study_id>12968</org_study_id>
    <nct_id>NCT03292757</nct_id>
  </id_info>
  <brief_title>FLOTOR Pilot Study</brief_title>
  <acronym>FLOTOR</acronym>
  <official_title>FLuOrescence to Identify the Thoracic Duct During Oesophageal Resections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oxford University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oxford University Hospitals NHS Trust</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 is a non-randomised study assessing the technique of using indocyanine green as a&#xD;
      fluorescent dye to highlight the thoracic duct during oesophectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The thoracic duct is the largest vessel of the lymphatic system in the body. It transports&#xD;
      chyle (a liquid containing both lymph and emulsified fats) from most of the body, including&#xD;
      the gastrointestinal tract, into the left internal jugular vein. It is largely located in the&#xD;
      thorax and is at risk of injury during the thoracic part of an oesophagectomy.&#xD;
&#xD;
      The reported incidence of thoracic duct injury during oesophagectomy is between 0.2 and&#xD;
      10.5%, although it may be under-reported in the literature. A review of prospective collected&#xD;
      complication data from 292 consecutive oesophagectomies performed in Oxford over a 5 year&#xD;
      period revealed a chyle leak rate of 9.9%. Chyle leak was associated in a doubling of median&#xD;
      length of post-operative stay from 8 to 16 days in these patients. Chylothorax has been&#xD;
      associated with a mortality of up to 30%.&#xD;
&#xD;
      Over the years, a number of attempts have been made to visualise chyle leakage following&#xD;
      thoracic duct injury including administration of enteral fat containing feed (e.g. double&#xD;
      cream), methylene blue and lymphoscintigraphy, but no studies have been published showing a&#xD;
      mechanism to aid thoracic duct identification at the index operation, and so prevent&#xD;
      injuries.&#xD;
&#xD;
      Fluorescence is a technique which uses fluorescent dyes (fluorophores) that emit invisible&#xD;
      (near infra-red (NIR)) light when they are excited by light at a particular wavelength. In&#xD;
      order to use this technique, a fluorescence-enabled camera is required in order to shine&#xD;
      light at that particular wavelength on the fluorophore and to capture the light emitted. This&#xD;
      is then displayed on a screen for the surgeon to see.&#xD;
&#xD;
      Indocyanine green (ICG) is a fluorescent molecule that is approved by the FDA (Food and Drug&#xD;
      Administration) and the MHRA for use in humans. It is a widely used near infra-red dye for&#xD;
      numerous operations. Near infra-red guided lymphatic mapping with ICG has gained much&#xD;
      attention over recent years and its use has widely been published in breast and colorectal&#xD;
      surgery. ICG has also been successfully used to identify the thoracic duct in a number of&#xD;
      case reports in both adults and children.&#xD;
&#xD;
      ICG can be injected into the small bowel mesentery to aid identification of thoracic duct&#xD;
      injury at re-exploration. This study aims to assess the feasibility of using ICG fluorescence&#xD;
      to identify the thoracic duct during oesophagectomy, with the eventual aim of developing its&#xD;
      routine use to prevent thoracic duct injuries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2017</start_date>
  <completion_date type="Actual">September 20, 2018</completion_date>
  <primary_completion_date type="Actual">August 20, 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of thoracic ducts seen under fluorescence versus number of thoracic ducts seen with white light. (Change over time)</measure>
    <time_frame>0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose</time_frame>
    <description>Thoracic duct visualised fluorescence assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Signal to background ratio of fluorescence in thoracic ducts between 2 methods of ICG administration.</measure>
    <time_frame>0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose</time_frame>
    <description>Thoracic duct fluorescence levels between methods of ICG administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Signal to background ratio of fluorescence in thoracic ducts between dosing levels.</measure>
    <time_frame>0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose</time_frame>
    <description>Thoracic duct fluorescence levels between ICG doses</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Chylothorax</condition>
  <condition>Esophageal Cancer</condition>
  <condition>Thoracic Duct Intra-Operative Injury</condition>
  <arm_group>
    <arm_group_label>Mesenteric ICG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Indocyanine green injected into the small bowel mesentery during oesophagectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Feeding jejunostomy ICG (cream)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Indocyanine green mixed with cream infiltrated into the feeding jejunostomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Indocyanine Green</intervention_name>
    <description>Fluorescent dye - indocyanine green</description>
    <arm_group_label>Feeding jejunostomy ICG (cream)</arm_group_label>
    <arm_group_label>Mesenteric ICG</arm_group_label>
    <other_name>ICG</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is willing and able to give informed consent for participation in the&#xD;
             study.&#xD;
&#xD;
          -  Male or Female, aged 18 years or above.&#xD;
&#xD;
          -  Undergoing elective oesophagectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy to iodine or ICG&#xD;
&#xD;
          -  Female patient who is pregnant, planning pregnancy or breastfeeding&#xD;
&#xD;
          -  Patient has a lactose intolerance (excluded only from receiving cream method)&#xD;
&#xD;
          -  Known significant liver failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Gillies, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consultant Upper GI Surgeon</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thomas Barnes, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Research Fellow</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Upper GI Surgery, Oxford University Hospitals</name>
      <address>
        <city>Headington</city>
        <state>Oxfordshire</state>
        <zip>OX3 7LE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>November 16, 2018</last_update_submitted>
  <last_update_submitted_qc>November 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oxford University Hospitals NHS Trust</investigator_affiliation>
    <investigator_full_name>Thomas Barnes</investigator_full_name>
    <investigator_title>Clinical Research Fellow</investigator_title>
  </responsible_party>
  <keyword>Fluorescence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chylothorax</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share individual participant data</ipd_description>
  </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/NCT03292757
org study id: 12968
nct id: NCT03292757
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a non-randomised study assessing the technique of using indocyanine green as a
      fluorescent dye to highlight the thoracic duct during oesophectomy.
The thoracic duct is the largest vessel of the lymphatic system in the body. It transports
      chyle (a liquid containing both lymph and emulsified fats) from most of the body, including
      the gastrointestinal tract, into the left internal jugular vein. It is largely located in the
      thorax and is at risk of injury during the thoracic part of an oesophagectomy.

      The reported incidence of thoracic duct injury during oesophagectomy is between 0.2 and
      10.5%, although it may be under-reported in the literature. A review of prospective collected
      complication data from 292 consecutive oesophagectomies performed in Oxford over a 5 year
      period revealed a chyle leak rate of 9.9%. Chyle leak was associated in a doubling of median
      length of post-operative stay from 8 to 16 days in these patients. Chylothorax has been
      associated with a mortality of up to 30%.

      Over the years, a number of attempts have been made to visualise chyle leakage following
      thoracic duct injury including administration of enteral fat containing feed (e.g. double
      cream), methylene blue and lymphoscintigraphy, but no studies have been published showing a
      mechanism to aid thoracic duct identification at the index operation, and so prevent
      injuries.

      Fluorescence is a technique which uses fluorescent dyes (fluorophores) that emit invisible
      (near infra-red (NIR)) light when they are excited by light at a particular wavelength. In
      order to use this technique, a fluorescence-enabled camera is required in order to shine
      light at that particular wavelength on the fluorophore and to capture the light emitted. This
      is then displayed on a screen for the surgeon to see.

      Indocyanine green (ICG) is a fluorescent molecule that is approved by the FDA (Food and Drug
      Administration) and the MHRA for use in humans. It is a widely used near infra-red dye for
      numerous operations. Near infra-red guided lymphatic mapping with ICG has gained much
      attention over recent years and its use has widely been published in breast and colorectal
      surgery. ICG has also been successfully used to identify the thoracic duct in a number of
      case reports in both adults and children.

      ICG can be injected into the small bowel mesentery to aid identification of thoracic duct
      injury at re-exploration. This study aims to assess the feasibility of using ICG fluorescence
      to identify the thoracic duct during oesophagectomy, with the eventual aim of developing its
      routine use to prevent thoracic duct injuries.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of thoracic ducts seen under fluorescence versus number of thoracic ducts seen with white light. (Change over time)
time frame: 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose
description: Thoracic duct visualised fluorescence assessment
measure: Signal to background ratio of fluorescence in thoracic ducts between 2 methods of ICG administration.
time frame: 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose
description: Thoracic duct fluorescence levels between methods of ICG administration
measure: Signal to background ratio of fluorescence in thoracic ducts between dosing levels.
time frame: 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose
description: Thoracic duct fluorescence levels between ICG doses
arm group label: Mesenteric ICG
arm group type: Experimental
description: Indocyanine green injected into the small bowel mesentery during oesophagectomy.
arm group label: Feeding jejunostomy ICG (cream)
arm group type: Experimental
description: Indocyanine green mixed with cream infiltrated into the feeding jejunostomy.
intervention type: Drug
intervention name: Indocyanine Green
description: Fluorescent dye - indocyanine green
arm group label: Feeding jejunostomy ICG (cream)
arm group label: Mesenteric ICG
other name: ICG
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Richard Gillies, MBChB
role: Principal Investigator
affiliation: Consultant Upper GI Surgeon
last name: Thomas Barnes, MBChB
role: Principal Investigator
affiliation: Clinical Research Fellow
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Oxford University Hospitals NHS Trust
investigator full name: Thomas Barnes
investigator title: Clinical Research Fellow
mesh term: Chylothorax
sharing ipd: No
ipd description: No plan to share individual participant data