Clinical trial NCT03808779: A Multicenter Trial of Radiofrequency Ablation vs. Surgery as Treatment of Papillary Thyroid Microcarcinoma.
Official title: A Multicenter, Randomized and Controlled Trial of Radiofrequency Ablation vs. Conventional Surgery as Treatment of Papillary Thyroid Microcarcinoma (PTMC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Papillary Thyroid Microcarcinoma
Keywords: Papillary Thyroid Microcarcinoma
Radiofrequency Ablation
Surgery
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Recurrent-free Survival Rate
timeFrame: 5 years
Secondary outcomes:
measure: The Diameter of Lesion
timeFrame: 5 years
measure: The Volume of Lesion
timeFrame: 5 years
measure: Postoperative Complications
timeFrame: up to 12 months
measure: Serum Concentration of Serological Examination of Thyroid Function
timeFrame: up to 12 months
measure: Medical Cost
timeFrame: up to 12 months
measure: Hospital Duration
timeFrame: through study completion, an average of 7 days
measure: Patient Satisfaction: questionnaire
timeFrame: 5 years
measure: Anxiety index measured by psychological questionnaire
timeFrame: up to 5 years
measure: Overall Survival in Patients with PTMC
timeFrame: 5 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: General Surgery Department, Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Kharkiv
country: Ukraine
facility: Interventional Oncology Centre, State Institution "Grigoriev Intstitute for Medical Radiology NAMS of Ukraine"
Study officials:
affiliation: Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Pintong Huang, director
role: PRINCIPAL_INVESTIGATOR
References: