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

Last updated: December 16, 2020
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03808779
2013-004-A012
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 arteryand 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

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

Study Design

Total Participants: 200
Study Start date:
June 01, 2019
Estimated Completion Date:
February 01, 2024

Study 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.

Connect with a study center

  • General Surgery Department, Tianjin Medical University General Hospital

    Tianjin, Tianjin 022
    China

    Active - Recruiting

  • Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang 0571
    China

    Active - Recruiting

  • Interventional Oncology Centre, State Institution "Grigoriev Intstitute for Medical Radiology NAMS of Ukraine"

    Kharkiv, 61024
    Ukraine

    Site Not Available

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