<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/NCT02249780</url>
  </required_header>
  <id_info>
    <org_study_id>14-160</org_study_id>
    <nct_id>NCT02249780</nct_id>
  </id_info>
  <brief_title>Assessing Parathyroid Glands Vascularisation by ICG Fluoroscopy</brief_title>
  <official_title>The Use of Indocyanine Green Fluorescence to Assses the Vascularisation of the Parathyroid Glands During Thyroid Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Geneva University, School of medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Geneva</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate parathyroid gland perfusion during total thyroidectomy or thyroid totalisation&#xD;
      surgery. Create an objective basis for the decision whether or not to transplant the&#xD;
      parathyroid glands. Avoide postoperative serum calcium and parathyroid hormone dosages, and&#xD;
      thus abstention of systematic supplementation with calcium and vitamin D in case of good&#xD;
      perfusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Parathyroid intraoperative indocyanine green (ICG) angiography is a new concept. To simplify&#xD;
      the procedure the investigators have classified images into three categories: ICG 2: good&#xD;
      blood supply (the gland has a white color); ICG 1: traumatic gland (the gland has a grayish&#xD;
      color) and ICG 0: the gland is not vascularized (she has a black color). The investigators&#xD;
      have applied the same criteria for visual values.&#xD;
&#xD;
      The investigators will randomize 138 patients with good ICG test values (at least one gland&#xD;
      that is visually ≥1 and ICG 2): 69 will be subject to the usual postoperative care in the&#xD;
      investigators service: 24 hours monitoring with dosage of calcium and PTH in the morning on&#xD;
      postoperative day 1 and routine supplementation with Calcimagon D3 Forte (1g Calcium and 800&#xD;
      IU of 25-OH-vitamin D) BD by mouth until postoperative follow-up appointment, which takes&#xD;
      place between day 10 and 15. Depending on the results of blood tests patients will also be&#xD;
      given Rocaltrol substitution (1, 25-OH-Vitamin D) 0.5mcg BD. The remaining patients will be&#xD;
      monitored 24 hours in hospital looking for clinical signs and symptoms of hypocalcemia but&#xD;
      without any blood dosage or systematic supplementation. If signs and / or symptoms of&#xD;
      hypocalcemia develop (tingling, muscle spasms, Chvostek sign), a blood test will be performed&#xD;
      and patients will be substituted by the usual protocol. All patients will be reviewed at 10 -&#xD;
      15 days of the intervention with the relevant balance sheet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative parathyroid function</measure>
    <time_frame>10 days after surgery</time_frame>
    <description>All patients will be reviewed at 10-15 days after surgery and blood tests will be done. Investigators will check the number of patients with serum calcium and parathyroid hormone in normal ranges at ten days after surgery in both arms of the study. Low parathyroid function will be diagnosed when corrected calcium &lt; 2mmol/l, and PTH &lt; 1.1 pmol/l.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Calcium and parathormone dosage after surgery</measure>
    <time_frame>10 days after surgery</time_frame>
    <description>Number of patients with good calcium and parathormone values at 10 days after surgery without calcium and vitamin D supplementation in the selected group.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Economic impact</measure>
    <time_frame>From surgery day to 10 days after surgery</time_frame>
    <description>Compare the costs of both procedures: standard procedure and new treatment and then evaluate the economic impact of this preventig mesure, and the possibility to undergo ambulatory surgery</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">146</enrollment>
  <condition>Parathyroid Function Low Adverse Event</condition>
  <arm_group>
    <arm_group_label>New treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In patients with at least one well perfused parathyroid gland on ICG parathyroid angiography, no postoperative parathyroid dosage and supplementation will be done. Calcium and parathormone dosage will be done 10 days after surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standart treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In those patients in whom at least on of the four parathyroid glands is well perused, postoperative parathyroid function test and parathyroid supplementation will be done. Calcium and parathormone dosage will be done at 24 hours and 10 days after surgery. Prophylactic supplementation of calcium and Vitamin D will be given.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Postoperative parathyroid function test</intervention_name>
    <description>Calcium and parathormone dosage at 24 hours and ten day after surgery</description>
    <arm_group_label>Standart treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No postoperative parathyroid dosage and supplementation</intervention_name>
    <description>The patients will be clinically followed for 24 hours after surgery and caclium and parathormone dosage will be done at ten days after surgery. No supplementation will be given.</description>
    <arm_group_label>New treatment</arm_group_label>
    <other_name>Parathiroid function testing</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ICG parathyroid angiography</intervention_name>
    <description>Injection of 3,5 mL of indocyanine green intravenously and perform angiography of parathyroid glands after thyroid removal.</description>
    <arm_group_label>New treatment</arm_group_label>
    <arm_group_label>Standart treatment</arm_group_label>
    <other_name>Indoyanine green angiography</other_name>
    <other_name>Indoyanine green fluoroscopy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Parathyroid supplementation</intervention_name>
    <description>Supplementration with Calcimagon D3 Forte (1gr Calcium and 800 IU of 25-OH-vitamin D) from surgery day to up to 10 days afeter surgery.</description>
    <arm_group_label>Standart treatment</arm_group_label>
    <other_name>Hypocalcemia post thyroidectomy treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients undergoing total thyroidectomy or a totalisation thyroid procedure.&#xD;
&#xD;
          -  Patients capable of understanding and able to understand the study.&#xD;
&#xD;
          -  Values visually 2 and ICG 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parathyroid disease or prior parathyroidectomy&#xD;
&#xD;
          -  Lack of informed consent&#xD;
&#xD;
          -  Altered mental status of the patient.&#xD;
&#xD;
          -  ICG values &lt;2.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frédéric Triponez, Professor</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Geneva</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wolfram Karenovics, SPR</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Geneva</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Frédéric Ris, Consultant</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Geneva</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Valentina Belfontali, Resident</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Geneva</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jordi Vidal Fortuny, SPR</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital, Geneva</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospitals Geneva</name>
      <address>
        <city>Geneva</city>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>April 15, 2016</last_update_submitted>
  <last_update_submitted_qc>April 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>JORDI VIDAL FORTUNY</investigator_full_name>
    <investigator_title>Chef de clinique</investigator_title>
  </responsible_party>
  <keyword>Parathyroid gland angiography</keyword>
  <keyword>Parathyroid gland indocyanine green angiography</keyword>
  <keyword>Parathyroid gland indocyanine green fluoroscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neovascularization, Pathologic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parathyroid Hormone</mesh_term>
  </intervention_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/NCT02249780
org study id: 14-160
nct id: NCT02249780
lead sponsor: 
collaborator: 
has dmc: Yes
Evaluate parathyroid gland perfusion during total thyroidectomy or thyroid totalisation
      surgery. Create an objective basis for the decision whether or not to transplant the
      parathyroid glands. Avoide postoperative serum calcium and parathyroid hormone dosages, and
      thus abstention of systematic supplementation with calcium and vitamin D in case of good
      perfusion.
Parathyroid intraoperative indocyanine green (ICG) angiography is a new concept. To simplify
      the procedure the investigators have classified images into three categories: ICG 2: good
      blood supply (the gland has a white color); ICG 1: traumatic gland (the gland has a grayish
      color) and ICG 0: the gland is not vascularized (she has a black color). The investigators
      have applied the same criteria for visual values.

      The investigators will randomize 138 patients with good ICG test values (at least one gland
      that is visually ≥1 and ICG 2): 69 will be subject to the usual postoperative care in the
      investigators service: 24 hours monitoring with dosage of calcium and PTH in the morning on
      postoperative day 1 and routine supplementation with Calcimagon D3 Forte (1g Calcium and 800
      IU of 25-OH-vitamin D) BD by mouth until postoperative follow-up appointment, which takes
      place between day 10 and 15. Depending on the results of blood tests patients will also be
      given Rocaltrol substitution (1, 25-OH-Vitamin D) 0.5mcg BD. The remaining patients will be
      monitored 24 hours in hospital looking for clinical signs and symptoms of hypocalcemia but
      without any blood dosage or systematic supplementation. If signs and / or symptoms of
      hypocalcemia develop (tingling, muscle spasms, Chvostek sign), a blood test will be performed
      and patients will be substituted by the usual protocol. All patients will be reviewed at 10 -
      15 days of the intervention with the relevant balance sheet.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Postoperative parathyroid function
time frame: 10 days after surgery
description: All patients will be reviewed at 10-15 days after surgery and blood tests will be done. Investigators will check the number of patients with serum calcium and parathyroid hormone in normal ranges at ten days after surgery in both arms of the study. Low parathyroid function will be diagnosed when corrected calcium < 2mmol/l, and PTH < 1.1 pmol/l.
measure: Calcium and parathormone dosage after surgery
time frame: 10 days after surgery
description: Number of patients with good calcium and parathormone values at 10 days after surgery without calcium and vitamin D supplementation in the selected group.
measure: Economic impact
time frame: From surgery day to 10 days after surgery
description: Compare the costs of both procedures: standard procedure and new treatment and then evaluate the economic impact of this preventig mesure, and the possibility to undergo ambulatory surgery
arm group label: New treatment
arm group type: Experimental
description: In patients with at least one well perfused parathyroid gland on ICG parathyroid angiography, no postoperative parathyroid dosage and supplementation will be done. Calcium and parathormone dosage will be done 10 days after surgery.
arm group label: Standart treatment
arm group type: Active Comparator
description: In those patients in whom at least on of the four parathyroid glands is well perused, postoperative parathyroid function test and parathyroid supplementation will be done. Calcium and parathormone dosage will be done at 24 hours and 10 days after surgery. Prophylactic supplementation of calcium and Vitamin D will be given.
intervention type: Procedure
intervention name: Postoperative parathyroid function test
description: Calcium and parathormone dosage at 24 hours and ten day after surgery
arm group label: Standart treatment
intervention type: Procedure
intervention name: No postoperative parathyroid dosage and supplementation
description: The patients will be clinically followed for 24 hours after surgery and caclium and parathormone dosage will be done at ten days after surgery. No supplementation will be given.
arm group label: New treatment
other name: Parathiroid function testing
intervention type: Procedure
intervention name: ICG parathyroid angiography
description: Injection of 3,5 mL of indocyanine green intravenously and perform angiography of parathyroid glands after thyroid removal.
arm group label: New treatment
arm group label: Standart treatment
other name: Indoyanine green angiography
other name: Indoyanine green fluoroscopy
intervention type: Drug
intervention name: Parathyroid supplementation
description: Supplementration with Calcimagon D3 Forte (1gr Calcium and 800 IU of 25-OH-vitamin D) from surgery day to up to 10 days afeter surgery.
arm group label: Standart treatment
other name: Hypocalcemia post thyroidectomy treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Frédéric Triponez, Professor
role: Study Director
affiliation: University Hospital, Geneva
last name: Wolfram Karenovics, SPR
role: Principal Investigator
affiliation: University Hospital, Geneva
last name: Frédéric Ris, Consultant
role: Principal Investigator
affiliation: University Hospital, Geneva
last name: Valentina Belfontali, Resident
role: Principal Investigator
affiliation: University Hospital, Geneva
last name: Jordi Vidal Fortuny, SPR
role: Study Chair
affiliation: University Hospital, Geneva
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: JORDI VIDAL FORTUNY
investigator title: Chef de clinique
mesh term: Neovascularization, Pathologic
mesh term: Parathyroid Hormone