<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/NCT03840655</url>
  </required_header>
  <id_info>
    <org_study_id>2017PHB101-01</org_study_id>
    <nct_id>NCT03840655</nct_id>
  </id_info>
  <brief_title>Fluorescent Thoracoscopy Used in Surgery for Palmar Hyperhidrosis</brief_title>
  <official_title>Fluorescent Thoracoscopy Used in Surgery for Palmar Hyperhidrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Municipal Science &amp; Technology Commission</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University People's Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      T3/T4 endoscopic thoracic sympathicotomy is a widely accepted and effective treatment for&#xD;
      primary palmar hyperhidrosis. However, sympathetic ganglions are invisible with traditional&#xD;
      thoracoscopy and until now, the location of ganglions are confirmed by rib indirectly. The&#xD;
      team from thoracic department of Peking University People's Hospital discovered that the&#xD;
      sympathetic ganglions can be visualized with fluorescent thoracoscopy. Thus, investigators&#xD;
      want to apply fluorescent thoracoscopy in sympathicotomy of palmar hyperhidrosis, to conduct&#xD;
      a more precise operation and compare the efficiency of the novel and traditional methods.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 16, 2017</start_date>
  <completion_date type="Actual">September 1, 2018</completion_date>
  <primary_completion_date type="Actual">September 1, 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Anatomical variation of the sympathetic ganglions</measure>
    <time_frame>during surgery</time_frame>
    <description>Record the spatial relationship between sympathetic ganglions and ribs, for example: T3/R4 represents the T3 sympathetic ganglion is located on the 4th rib.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement of palmar sweating</measure>
    <time_frame>1 month after surgery</time_frame>
    <description>Use questionnaire including 3 descriptive names of scale ( over dry, comfortable and wet) to record the surgical effect on palmar sweating.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of compensatory hyperhidrosis</measure>
    <time_frame>1 month after surgery</time_frame>
    <description>Use questionnaire including 4 descriptive names of scale ( none, mild, moderate and severe) to record the side effect (compensatory hyperhidrosis) of this surgery.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">89</enrollment>
  <condition>Palmar Hyperhidrosis</condition>
  <arm_group>
    <arm_group_label>palmar hyperhidrosis</arm_group_label>
    <description>VATS R4 Sympathicotomy performed on all patients. Fluorescent thoracoscopy was used to identify the shifting mode of sympathetic ganglions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Near-Infrared Imaging Thoracoscopy</intervention_name>
    <description>Sympathicotomy performed by near-infrared imaging thoracoscopy</description>
    <arm_group_label>palmar hyperhidrosis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients suffering from primary palmar hyperhidrosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosed with primary palmar hyperhydrosis.&#xD;
&#xD;
          2. Accept surgical treatment and signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Liver dysfunction.&#xD;
&#xD;
          2. Allergic to indocyanine green.&#xD;
&#xD;
          3. Can't tolerate thoracoscopic surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Peking University People'S Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>+86-010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 9, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 12, 2019</last_update_submitted>
  <last_update_submitted_qc>February 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University People's Hospital</investigator_affiliation>
    <investigator_full_name>Jun Wang</investigator_full_name>
    <investigator_title>Department Chief</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperhidrosis</mesh_term>
  </condition_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/NCT03840655
org study id: 2017PHB101-01
nct id: NCT03840655
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
T3/T4 endoscopic thoracic sympathicotomy is a widely accepted and effective treatment for
      primary palmar hyperhidrosis. However, sympathetic ganglions are invisible with traditional
      thoracoscopy and until now, the location of ganglions are confirmed by rib indirectly. The
      team from thoracic department of Peking University People's Hospital discovered that the
      sympathetic ganglions can be visualized with fluorescent thoracoscopy. Thus, investigators
      want to apply fluorescent thoracoscopy in sympathicotomy of palmar hyperhidrosis, to conduct
      a more precise operation and compare the efficiency of the novel and traditional methods.
observational model: Cohort
time perspective: Prospective
measure: Anatomical variation of the sympathetic ganglions
time frame: during surgery
description: Record the spatial relationship between sympathetic ganglions and ribs, for example: T3/R4 represents the T3 sympathetic ganglion is located on the 4th rib.
measure: Improvement of palmar sweating
time frame: 1 month after surgery
description: Use questionnaire including 3 descriptive names of scale ( over dry, comfortable and wet) to record the surgical effect on palmar sweating.
measure: Degree of compensatory hyperhidrosis
time frame: 1 month after surgery
description: Use questionnaire including 4 descriptive names of scale ( none, mild, moderate and severe) to record the side effect (compensatory hyperhidrosis) of this surgery.
arm group label: palmar hyperhidrosis
description: VATS R4 Sympathicotomy performed on all patients. Fluorescent thoracoscopy was used to identify the shifting mode of sympathetic ganglions.
intervention type: Procedure
intervention name: Near-Infrared Imaging Thoracoscopy
description: Sympathicotomy performed by near-infrared imaging thoracoscopy
arm group label: palmar hyperhidrosis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University People's Hospital
investigator full name: Jun Wang
investigator title: Department Chief
mesh term: Hyperhidrosis