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A Multicenter Trial of Radiofrequency Ablation vs. Surgery as Treatment of Papillary Thyroid Microcarcinoma.

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ClinicalTrials.gov Identifier: NCT03808779
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
huang pintong, Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Papillary Thyroid Microcarcinoma Procedure: Radiofrequency Ablation Procedure: Conventional Surgery Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized and Controlled Trial of Radiofrequency Ablation vs. Conventional Surgery as Treatment of Papillary Thyroid Microcarcinoma (PTMC)
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : February 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid

Arm Intervention/treatment
Experimental: Radiofrequency Ablation
Eligible participants with PTMC will be randomly assigned to this group and undergo radiofrequency ablation(RFA) procedure.
Procedure: Radiofrequency Ablation
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.
Other Name: RFA

Active Comparator: Conventional Surgery
Eligible participants with PTMC will be randomly assigned to this group and undergo total/thyroid lobectomy procedure.
Procedure: Conventional Surgery
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.
Other Name: Total thyroidectomy/Thyroid lobectomy




Primary Outcome Measures :
  1. Recurrent-free Survival Rate [ Time Frame: 5 years ]
    record detecting recurrence of PTMC post-surgery or post-FRA


Secondary Outcome Measures :
  1. The Diameter of Lesion [ Time Frame: 5 years ]
    record diameter reduce rate after RFA procedure

  2. The Volume of Lesion [ Time Frame: 5 years ]
    record volume reduce rate after RFA procedure

  3. Postoperative Complications [ Time Frame: up to 12 months ]
    record relevant complications after surgery or RFA

  4. Serum Concentration of Serological Examination of Thyroid Function [ Time Frame: up to 12 months ]
    record the serum concentration of TSH/T3/FT3/T4/FT4/TPOAb/TgAb/TRAb.

  5. Medical Cost [ Time Frame: up to 12 months ]
    record hospital expenditure

  6. Hospital Duration [ Time Frame: through study completion, an average of 7 days ]
    record hospital stay time

  7. Patient Satisfaction: questionnaire [ Time Frame: 5 years ]

    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.


  8. Anxiety index measured by psychological questionnaire [ Time Frame: up to 5 years ]
    1. I feel more nervous and anxious than usual (anxiety)
    2. I feel scared for no reason (fear)
    3. I am easily upset or frightened (frightened)
    4. 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)


  9. Overall Survival in Patients with PTMC [ Time Frame: 5 years ]
    record 5 year overall survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosis of PTMC (largest dimension<10mm)
  • Age >=18 years old
  • Bethesda Category V or VI
  • Single nodule without thyroid capsule contact
  • Nodule has more than 3mm distance far from recurrent laryngeal nerve, carotid artery and trachea.
  • No clinical evidences show there is local or distant metastasis.
  • Without chemotherapy, radiotherapy and other related therapies.
  • Patients and their family member totally understand and sign the informed consent.

Exclusion Criteria:

  • Multifocal PTMC
  • Combined with other types of thyroid cancer or hyperthyroidism.
  • Contralateral vocal cord paralysis
  • With local or distant metastasis
  • Pregnant woman
  • With radiation exposure history

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03808779


Contacts
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Contact: Pintong Huang, director +8618857168333 huangpintong@126.com
Contact: jifan Chen, collegue +8613605771565 chenjifan0619@163.com

Locations
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China, Tianjin
General Surgery Department, Tianjin Medical University General Hospital Recruiting
Tianjin, Tianjin, China, 022
Contact: Jie Zhang, director    +8615822798742    wzq_bf@163.com   
Contact: Ruoyu Jiang, collegue    +8618622632394    jiangruoyu000@aliyun.com   
China, Zhejiang
Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 0571
Contact: Pintong Huang, director    +8618857168333    huangpintong@126.com   
Contact: Jifan Chen, collegue    +8613605771565    chenjifan0619@163.com   
Ukraine
Interventional Oncology Centre, State Institution "Grigoriev Intstitute for Medical Radiology NAMS of Ukraine" Not yet recruiting
Kharkiv, Ukraine, 61024
Contact: Sviatoslav Balaka    +380509356958    balaka.svjat@gmail.com   
Contact: Hennadii Hrechikhin    +380509188586    interv.oncology@gmail.com   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Principal Investigator: Pintong Huang, director Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
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Responsible Party: huang pintong, Director of Department of Ultrasound, Professor of Zhejiang University School of Medicine, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03808779    
Other Study ID Numbers: 2013-004-A012
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by huang pintong, Second Affiliated Hospital, School of Medicine, Zhejiang University:
Papillary Thyroid Microcarcinoma
Radiofrequency Ablation
Surgery
Additional relevant MeSH terms:
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Carcinoma, Papillary
Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms