A Multicenter Trial of Radiofrequency Ablation vs. Surgery as Treatment of Papillary Thyroid Microcarcinoma.
- Conditions
- Papillary Thyroid Microcarcinoma
- Interventions
- Procedure: Conventional SurgeryProcedure: Radiofrequency Ablation
- Registration Number
- NCT03808779
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional Surgery Conventional Surgery Eligible participants with PTMC will be randomly assigned to this group and undergo total/thyroid lobectomy procedure. Radiofrequency Ablation Radiofrequency Ablation Eligible participants with PTMC will be randomly assigned to this group and undergo radiofrequency ablation(RFA) procedure.
- Primary Outcome Measures
Name Time Method Recurrent-free Survival Rate 5 years record detecting recurrence of PTMC post-surgery or post-FRA
- Secondary Outcome Measures
Name Time Method Postoperative Complications up to 12 months record relevant complications after surgery or RFA
Patient Satisfaction: questionnaire 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.Anxiety index measured by psychological questionnaire 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)The Diameter of Lesion 5 years record diameter reduce rate after RFA procedure
The Volume of Lesion 5 years record volume reduce rate after RFA procedure
Serum Concentration of Serological Examination of Thyroid Function up to 12 months record the serum concentration of TSH/T3/FT3/T4/FT4/TPOAb/TgAb/TRAb.
Medical Cost up to 12 months record hospital expenditure
Hospital Duration through study completion, an average of 7 days record hospital stay time
Overall Survival in Patients with PTMC 5 years record 5 year overall survival
Trial Locations
- Locations (3)
General Surgery Department, Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Interventional Oncology Centre, State Institution "Grigoriev Intstitute for Medical Radiology NAMS of Ukraine"
🇺🇦Kharkiv, Ukraine