<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/NCT03808779</url>
  </required_header>
  <id_info>
    <org_study_id>2013-004-A012</org_study_id>
    <nct_id>NCT03808779</nct_id>
  </id_info>
  <brief_title>A Multicenter Trial of Radiofrequency Ablation vs. Surgery as Treatment of Papillary Thyroid Microcarcinoma.</brief_title>
  <official_title>A Multicenter, Randomized and Controlled Trial of Radiofrequency Ablation vs. Conventional Surgery as Treatment of Papillary Thyroid Microcarcinoma (PTMC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</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>
      The treatment of Papillary Thyroid Microcarcinoma (PTMC) nowadays varies among physicians,&#xD;
      surgeons and radiologist. The recently published articles show that the prognosis of PTMC by&#xD;
      different means of treatment strategies tends to be good. But multicentered, randomized,&#xD;
      parallel and prospective study is rare. RFA is the abbreviation of &quot;Radiofrequency Ablation&quot;,&#xD;
      which tends to be an alternative strategy except conventional surgery. The investigator aims&#xD;
      to confirm whether RFA for treating PTMC braces same effectiveness and prognosis comparing&#xD;
      with conventional surgery. Besides, this trial also investigates the safety, economy and&#xD;
      psychological quality under different treatments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The incidence of thyroid carcinoma, especially the papillary thyroid microcarcinoma (PTMC),&#xD;
      has increasingly rapidly, due to the development of technologies of diagnosis, during the&#xD;
      past 20 years. PTMC defined by the World Health Organization (WTO) as the largest dimension&#xD;
      less than 1 cm. Previous autopsy study demonstrated that the lesions are normal in many&#xD;
      people and accompany them latently until they die because of another reasons. The long-term&#xD;
      outcome of PTMC is good and, as expected, more than 90% PTMC aren't progress for many years.&#xD;
&#xD;
      Ultrasound-guided Radiofrequency Ablation (RFA) treatment was introduced to clinical practice&#xD;
      few years ago. According to the 2015 American Thyroid Association (ATA) guideline, the&#xD;
      treatment of radiofrequency and laser ablation are mentioned to be used in recurrent thyroid&#xD;
      cancer. But clinical practice shows that the RFA treatment for low risk PTMC braces well&#xD;
      effect，low financial budget，high safety and even rare postoperative complication.&#xD;
&#xD;
      Although the cohort study was performed before, the real answer concerning about whether RFA&#xD;
      is a rational choice for treating PTMC lacks more powerful evidences. The investigator&#xD;
      considers to perform a randomized, controlled and multicenter study as a high-quality&#xD;
      evidence and demonstrated the effect of PRF in low risk PTMC treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Anticipated">February 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2024</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>Recurrent-free Survival Rate</measure>
    <time_frame>5 years</time_frame>
    <description>record detecting recurrence of PTMC post-surgery or post-FRA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Diameter of Lesion</measure>
    <time_frame>5 years</time_frame>
    <description>record diameter reduce rate after RFA procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Volume of Lesion</measure>
    <time_frame>5 years</time_frame>
    <description>record volume reduce rate after RFA procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Complications</measure>
    <time_frame>up to 12 months</time_frame>
    <description>record relevant complications after surgery or RFA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Concentration of Serological Examination of Thyroid Function</measure>
    <time_frame>up to 12 months</time_frame>
    <description>record the serum concentration of TSH/T3/FT3/T4/FT4/TPOAb/TgAb/TRAb.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical Cost</measure>
    <time_frame>up to 12 months</time_frame>
    <description>record hospital expenditure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Duration</measure>
    <time_frame>through study completion, an average of 7 days</time_frame>
    <description>record hospital stay time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction: questionnaire</measure>
    <time_frame>5 years</time_frame>
    <description>measured by satisfaction questionnaire designed by investigator group： items：&#xD;
1．Are you satisfied with surgery? 2.Are you satisfied with the RFA procedure? scale range from 1 to 10； by the increasing of scale, the outcome is defined as good.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety index measured by psychological questionnaire</measure>
    <time_frame>up to 5 years</time_frame>
    <description>I feel more nervous and anxious than usual (anxiety)&#xD;
I feel scared for no reason (fear)&#xD;
I am easily upset or frightened (frightened)&#xD;
I think I might be going crazy (madness) There are 20 questions (No. 5-20 don't show because of the 999 words restriction).&#xD;
scale range from 1 to 4 For the question 5,9,13,17,18, the outcome is define as good by the increasing of scale.&#xD;
For the others, the outcome is defined as bad by the increasting of scale.(scale 1=No or very few, scale2=sometimes, scale3=often, scale4=always)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival in Patients with PTMC</measure>
    <time_frame>5 years</time_frame>
    <description>record 5 year overall survival</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Papillary Thyroid Microcarcinoma</condition>
  <arm_group>
    <arm_group_label>Radiofrequency Ablation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible participants with PTMC will be randomly assigned to this group and undergo radiofrequency ablation(RFA) procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Eligible participants with PTMC will be randomly assigned to this group and undergo total/thyroid lobectomy procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radiofrequency Ablation</intervention_name>
    <description>Patients were supine with the neck exposure completely during the procedure. Local anesthesia with 1% lidocaine was injected at the subcutaneous puncture site and the thyroid anterior capsule. If the distance between the tumor and critical cervical structures was less than 5 mm, normal saline was injected to form at least 1 cm distance between the tumor and the critical structure to prevent the unwilling thermal injury. RFA was performed using the moving-shot technique and RFA power was 5 W, if a transient hyperechoic zone did not form at the electrode tip within 5-10 seconds. The RFA extent exceeded the tumor edge to prevent marginal residue and recurrence. The ablation was terminated when all portions of the target ablation area had changed to hyperechoic zones.</description>
    <arm_group_label>Radiofrequency Ablation</arm_group_label>
    <other_name>RFA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional Surgery</intervention_name>
    <description>Patient is performed total thyroidectomy or thyroid lobectomy depending on the intraoperative situation, disease condition and comprehensive judge by surgeon. Patients are routinely disinfected and spread the drapes after general anesthesia. Neck skin, fat and placenta muscle are incised and separated successively. The flap is separated to the upper edge of thyroid cartilage, neck white line is incised and anterior muscle group is separated. Then both sides thyroid lobes are exposed. Cut off the isthmus, ligature the thyroid artery, cut off the upper pole. Ligature and cut off the ipsilateral thyroid vein. Reveal and protect the ipsilateral recurrent laryngeal nerve and the parathyroid gland during the entire process.</description>
    <arm_group_label>Conventional Surgery</arm_group_label>
    <other_name>Total thyroidectomy/Thyroid lobectomy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosis of PTMC (largest dimension&lt;10mm)&#xD;
&#xD;
          -  Age &gt;=18 years old&#xD;
&#xD;
          -  Bethesda Category V or VI&#xD;
&#xD;
          -  Single nodule without thyroid capsule contact&#xD;
&#xD;
          -  Nodule has more than 3mm distance far from recurrent laryngeal nerve, carotid artery&#xD;
             and trachea.&#xD;
&#xD;
          -  No clinical evidences show there is local or distant metastasis.&#xD;
&#xD;
          -  Without chemotherapy, radiotherapy and other related therapies.&#xD;
&#xD;
          -  Patients and their family member totally understand and sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multifocal PTMC&#xD;
&#xD;
          -  Combined with other types of thyroid cancer or hyperthyroidism.&#xD;
&#xD;
          -  Contralateral vocal cord paralysis&#xD;
&#xD;
          -  With local or distant metastasis&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  With radiation exposure history&#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>Pintong Huang, director</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pintong Huang, director</last_name>
    <phone>+8618857168333</phone>
    <email>huangpintong@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>jifan Chen, collegue</last_name>
    <phone>+8613605771565</phone>
    <email>chenjifan0619@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>General Surgery Department, Tianjin Medical University General Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>022</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jie Zhang, director</last_name>
      <phone>+8615822798742</phone>
      <email>wzq_bf@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Ruoyu Jiang, collegue</last_name>
      <phone>+8618622632394</phone>
      <email>jiangruoyu000@aliyun.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>0571</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pintong Huang, director</last_name>
      <phone>+8618857168333</phone>
      <email>huangpintong@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Jifan Chen, collegue</last_name>
      <phone>+8613605771565</phone>
      <email>chenjifan0619@163.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Interventional Oncology Centre, State Institution &quot;Grigoriev Intstitute for Medical Radiology NAMS of Ukraine&quot;</name>
      <address>
        <city>Kharkiv</city>
        <zip>61024</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Sviatoslav Balaka</last_name>
      <phone>+380509356958</phone>
      <email>balaka.svjat@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Hennadii Hrechikhin</last_name>
      <phone>+380509188586</phone>
      <email>interv.oncology@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
    <country>Ukraine</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>January 13, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>December 16, 2020</last_update_submitted>
  <last_update_submitted_qc>December 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</investigator_affiliation>
    <investigator_full_name>huang pintong</investigator_full_name>
    <investigator_title>Director of Department of Ultrasound, Professor of Zhejiang University School of Medicine</investigator_title>
  </responsible_party>
  <keyword>Papillary Thyroid Microcarcinoma</keyword>
  <keyword>Radiofrequency Ablation</keyword>
  <keyword>Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Papillary</mesh_term>
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03808779
org study id: 2013-004-A012
nct id: NCT03808779
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The treatment of Papillary Thyroid Microcarcinoma (PTMC) nowadays varies among physicians,
      surgeons and radiologist. The recently published articles show that the prognosis of PTMC by
      different means of treatment strategies tends to be good. But multicentered, randomized,
      parallel and prospective study is rare. RFA is the abbreviation of "Radiofrequency Ablation",
      which tends to be an alternative strategy except conventional surgery. The investigator aims
      to confirm whether RFA for treating PTMC braces same effectiveness and prognosis comparing
      with conventional surgery. Besides, this trial also investigates the safety, economy and
      psychological quality under different treatments.
The incidence of thyroid carcinoma, especially the papillary thyroid microcarcinoma (PTMC),
      has increasingly rapidly, due to the development of technologies of diagnosis, during the
      past 20 years. PTMC defined by the World Health Organization (WTO) as the largest dimension
      less than 1 cm. Previous autopsy study demonstrated that the lesions are normal in many
      people and accompany them latently until they die because of another reasons. The long-term
      outcome of PTMC is good and, as expected, more than 90% PTMC aren't progress for many years.

      Ultrasound-guided Radiofrequency Ablation (RFA) treatment was introduced to clinical practice
      few years ago. According to the 2015 American Thyroid Association (ATA) guideline, the
      treatment of radiofrequency and laser ablation are mentioned to be used in recurrent thyroid
      cancer. But clinical practice shows that the RFA treatment for low risk PTMC braces well
      effect，low financial budget，high safety and even rare postoperative complication.

      Although the cohort study was performed before, the real answer concerning about whether RFA
      is a rational choice for treating PTMC lacks more powerful evidences. The investigator
      considers to perform a randomized, controlled and multicenter study as a high-quality
      evidence and demonstrated the effect of PRF in low risk PTMC treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recurrent-free Survival Rate
time frame: 5 years
description: record detecting recurrence of PTMC post-surgery or post-FRA
measure: The Diameter of Lesion
time frame: 5 years
description: record diameter reduce rate after RFA procedure
measure: The Volume of Lesion
time frame: 5 years
description: record volume reduce rate after RFA procedure
measure: Postoperative Complications
time frame: up to 12 months
description: record relevant complications after surgery or RFA
measure: Serum Concentration of Serological Examination of Thyroid Function
time frame: up to 12 months
description: record the serum concentration of TSH/T3/FT3/T4/FT4/TPOAb/TgAb/TRAb.
measure: Medical Cost
time frame: up to 12 months
description: record hospital expenditure
measure: Hospital Duration
time frame: through study completion, an average of 7 days
description: record hospital stay time
measure: Patient Satisfaction: questionnaire
time frame: 5 years
description: measured by satisfaction questionnaire designed by investigator group： items：
1．Are you satisfied with surgery? 2.Are you satisfied with the RFA procedure? scale range from 1 to 10； by the increasing of scale, the outcome is defined as good.
measure: Anxiety index measured by psychological questionnaire
time frame: up to 5 years
description: I feel more nervous and anxious than usual (anxiety)
I feel scared for no reason (fear)
I am easily upset or frightened (frightened)
I think I might be going crazy (madness) There are 20 questions (No. 5-20 don't show because of the 999 words restriction).
scale range from 1 to 4 For the question 5,9,13,17,18, the outcome is define as good by the increasing of scale.
For the others, the outcome is defined as bad by the increasting of scale.(scale 1=No or very few, scale2=sometimes, scale3=often, scale4=always)
measure: Overall Survival in Patients with PTMC
time frame: 5 years
description: record 5 year overall survival
arm group label: Radiofrequency Ablation
arm group type: Experimental
description: Eligible participants with PTMC will be randomly assigned to this group and undergo radiofrequency ablation(RFA) procedure.
arm group label: Conventional Surgery
arm group type: Active Comparator
description: Eligible participants with PTMC will be randomly assigned to this group and undergo total/thyroid lobectomy procedure.
intervention type: Procedure
intervention name: Radiofrequency Ablation
description: Patients were supine with the neck exposure completely during the procedure. Local anesthesia with 1% lidocaine was injected at the subcutaneous puncture site and the thyroid anterior capsule. If the distance between the tumor and critical cervical structures was less than 5 mm, normal saline was injected to form at least 1 cm distance between the tumor and the critical structure to prevent the unwilling thermal injury. RFA was performed using the moving-shot technique and RFA power was 5 W, if a transient hyperechoic zone did not form at the electrode tip within 5-10 seconds. The RFA extent exceeded the tumor edge to prevent marginal residue and recurrence. The ablation was terminated when all portions of the target ablation area had changed to hyperechoic zones.
arm group label: Radiofrequency Ablation
other name: RFA
intervention type: Procedure
intervention name: Conventional Surgery
description: Patient is performed total thyroidectomy or thyroid lobectomy depending on the intraoperative situation, disease condition and comprehensive judge by surgeon. Patients are routinely disinfected and spread the drapes after general anesthesia. Neck skin, fat and placenta muscle are incised and separated successively. The flap is separated to the upper edge of thyroid cartilage, neck white line is incised and anterior muscle group is separated. Then both sides thyroid lobes are exposed. Cut off the isthmus, ligature the thyroid artery, cut off the upper pole. Ligature and cut off the ipsilateral thyroid vein. Reveal and protect the ipsilateral recurrent laryngeal nerve and the parathyroid gland during the entire process.
arm group label: Conventional Surgery
other name: Total thyroidectomy/Thyroid lobectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pintong Huang, director
role: Principal Investigator
affiliation: Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
last name: Pintong Huang, director
phone: +8618857168333
email: huangpintong@126.com
last name: jifan Chen, collegue
phone: +8613605771565
email: chenjifan0619@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
country: China
country: Ukraine
responsible party type: Principal Investigator
investigator affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
investigator full name: huang pintong
investigator title: Director of Department of Ultrasound, Professor of Zhejiang University School of Medicine
mesh term: Carcinoma, Papillary
mesh term: Thyroid Neoplasms
mesh term: Thyroid Diseases
sharing ipd: Undecided