<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/NCT03813706</url>
  </required_header>
  <id_info>
    <org_study_id>ZhejiangU20190115</org_study_id>
    <nct_id>NCT03813706</nct_id>
  </id_info>
  <brief_title>the Dissection of Lymph Node Posterior to Right Recurrent Laryngeal Nerve for Papillary Thyroid Carcinoma</brief_title>
  <official_title>Prospective Study for the Dissection of Lymph Node Posterior to Right Recurrent Laryngeal Nerve for Papillary Thyroid Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhejiang University</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>
      This study was completed in two stages. In the first stage, 2000 participants were enrolled&#xD;
      according to the criteria. Following the principle of informed consent and voluntary consent&#xD;
      of patients, the standard operation was &quot;right or bilateral thyroidectomy + isthmus resection&#xD;
      + right area VI lymph node dissection + left area VI lymph node dissection + lateral neck&#xD;
      lymph node dissection&quot;. The age of participants, the size of right thyroid tumors, the&#xD;
      invasion of the capsule and the number of lateral neck lymph node metastasis were counted to&#xD;
      validate and improve the predictive model of lymph node posterior to the right recurrent&#xD;
      laryngeal nerve in papillary thyroid cancer (Y=-0.029×age+0.771×tumor size+0.660×capsular&#xD;
      invasion+1.331×right lateral lymph node metastasis-1.687, Y ≥0.16 means right recurrent&#xD;
      laryngeal nerve posterior lymph node metastasis).&#xD;
&#xD;
      In the second stage, 2000 participants assessed by the model without posterior right&#xD;
      recurrent laryngeal nerve metastasis were randomly divided into experimental group and&#xD;
      control group according to the principle of informed consent and voluntary. The right&#xD;
      recurrent laryngeal nerve posterior lymph nodes were not dissected in experimental group,&#xD;
      while the right recurrent laryngeal nerve posterior lymph nodes were routinely dissected in&#xD;
      control group. Through long-term follow-up and comparison of RFS and OS between the two&#xD;
      groups, the investigators can scientifically evaluate the effectiveness of the &quot;prediction&#xD;
      model of lymph node posterior to right recurrent laryngeal nerve metastasis in papillary&#xD;
      thyroid carcinoma&quot;, and seek evidence for accurate treatment of lymph node posterior to the&#xD;
      right recurrent laryngeal nerve in thyroid papillary carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">January 2020</start_date>
  <completion_date type="Anticipated">December 2040</completion_date>
  <primary_completion_date type="Anticipated">December 2040</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence of thyroid cancer</measure>
    <time_frame>Participants will be followed from the operation to 20 year (maximum)</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>Lymph Node Metastases</condition>
  <arm_group>
    <arm_group_label>LN-prRLN dissection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>no LN-prRLN dissection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>lymph node dissection</intervention_name>
    <description>The right cervical central compartment VI is subdivided into right cervical central VI-1 subzone and VI-2 subzone. Right central VI-1 subzone lies anterior to the RLN bounded by the hyoid bone superiorly, the suprasternal notch inferiorly, the inner edge of the common carotid artery laterally, and the midline of the trachea medially. Right central VI-2 subzone lies posterior to the right RLN. The superior, inferior, lateral, and medial borders are the laryngeal entry points of RLN, the intersection of the RLN with the innominate artery (near the right apical pleura), the inner edge of the common carotid artery, and esophagus, respectively. The floor of right central VI-2 is the prevertebral fascia.</description>
    <arm_group_label>LN-prRLN dissection</arm_group_label>
    <arm_group_label>no LN-prRLN dissection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Phase I:&#xD;
&#xD;
               1. aged from 18 years old to 80 years old;&#xD;
&#xD;
               2. the primary treatment of patients with right or bilateral PTC;&#xD;
&#xD;
               3. patients will voluntarily enter the study after informed consent.&#xD;
&#xD;
        Phase II:&#xD;
&#xD;
          1. aged from 18 years old to 80 years old;&#xD;
&#xD;
          2. the primary treatment of patients with right or bilateral PTC predicted to have no&#xD;
             LN-prRLN metastasis by the &quot;prediction model of LN-prRLN&quot;;&#xD;
&#xD;
          3. patients will voluntarily enter the study after informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patients refused to participate in the study;&#xD;
&#xD;
          2. non first operation patients;&#xD;
&#xD;
          3. other malignant tumor history;&#xD;
&#xD;
          4. distant metastasis;&#xD;
&#xD;
          5. history of neck trauma.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>July 2, 2019</last_update_submitted>
  <last_update_submitted_qc>July 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zhejiang University</investigator_affiliation>
    <investigator_full_name>Luo Dingcun</investigator_full_name>
    <investigator_title>vice president of hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Lymphatic Metastasis</mesh_term>
    <mesh_term>Thyroid Cancer, Papillary</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/NCT03813706
org study id: ZhejiangU20190115
nct id: NCT03813706
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study was completed in two stages. In the first stage, 2000 participants were enrolled
      according to the criteria. Following the principle of informed consent and voluntary consent
      of patients, the standard operation was "right or bilateral thyroidectomy + isthmus resection
      + right area VI lymph node dissection + left area VI lymph node dissection + lateral neck
      lymph node dissection". The age of participants, the size of right thyroid tumors, the
      invasion of the capsule and the number of lateral neck lymph node metastasis were counted to
      validate and improve the predictive model of lymph node posterior to the right recurrent
      laryngeal nerve in papillary thyroid cancer (Y=-0.029×age+0.771×tumor size+0.660×capsular
      invasion+1.331×right lateral lymph node metastasis-1.687, Y ≥0.16 means right recurrent
      laryngeal nerve posterior lymph node metastasis).

      In the second stage, 2000 participants assessed by the model without posterior right
      recurrent laryngeal nerve metastasis were randomly divided into experimental group and
      control group according to the principle of informed consent and voluntary. The right
      recurrent laryngeal nerve posterior lymph nodes were not dissected in experimental group,
      while the right recurrent laryngeal nerve posterior lymph nodes were routinely dissected in
      control group. Through long-term follow-up and comparison of RFS and OS between the two
      groups, the investigators can scientifically evaluate the effectiveness of the "prediction
      model of lymph node posterior to right recurrent laryngeal nerve metastasis in papillary
      thyroid carcinoma", and seek evidence for accurate treatment of lymph node posterior to the
      right recurrent laryngeal nerve in thyroid papillary carcinoma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recurrence of thyroid cancer
time frame: Participants will be followed from the operation to 20 year (maximum)
arm group label: LN-prRLN dissection
arm group type: Active Comparator
arm group label: no LN-prRLN dissection
arm group type: Experimental
intervention type: Procedure
intervention name: lymph node dissection
description: The right cervical central compartment VI is subdivided into right cervical central VI-1 subzone and VI-2 subzone. Right central VI-1 subzone lies anterior to the RLN bounded by the hyoid bone superiorly, the suprasternal notch inferiorly, the inner edge of the common carotid artery laterally, and the midline of the trachea medially. Right central VI-2 subzone lies posterior to the right RLN. The superior, inferior, lateral, and medial borders are the laryngeal entry points of RLN, the intersection of the RLN with the innominate artery (near the right apical pleura), the inner edge of the common carotid artery, and esophagus, respectively. The floor of right central VI-2 is the prevertebral fascia.
arm group label: LN-prRLN dissection
arm group label: no LN-prRLN dissection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Zhejiang University
investigator full name: Luo Dingcun
investigator title: vice president of hospital
mesh term: Thyroid Neoplasms
mesh term: Lymphatic Metastasis
mesh term: Thyroid Cancer, Papillary