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

  • STATUS
    Recruiting
  • End date
    Feb 1, 2024
  • participants needed
    200
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
Updated on 26 January 2021

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.

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 effectlow financial budgethigh 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.

Details
Condition Papillary Thyroid Microcarcinoma
Treatment conventional surgery, Radiofrequency ablation
Clinical Study IdentifierNCT03808779
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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