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

Zhejiang University

Status: Unknown

Conditions: Papillary Thyroid Microcarcinoma

Treatments: Procedure: Conventional Surgery; Procedure: Radiofrequency Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03808779

2013-004-A012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Radiofrequency Ablation

Experimental group

Description:

Eligible participants with PTMC will be randomly assigned to this group and undergo radiofrequency ablation(RFA) procedure.

Treatment:

Procedure: Radiofrequency Ablation

Conventional Surgery

Active Comparator group

Description:

Eligible participants with PTMC will be randomly assigned to this group and undergo total/thyroid lobectomy procedure.

Treatment:

Procedure: Conventional Surgery