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

A Multicenter, Randomized and Controlled Trial of Radiofrequency Ablation vs. Conventional Surgery as Treatment of Papillary Thyroid Microcarcinoma (PTMC)

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.

Study Overview

• Status: Recruiting
• Conditions: Papillary Thyroid Microcarcinoma
• Intervention / Treatment: Procedure: Radiofrequency Ablation; Procedure: Conventional Surgery

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jifan Chen, collegue; Phone Number: +8613605771565; Email: chenjifan0619@163.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 022
      • Recruiting
      • General Surgery Department, Tianjin Medical University General Hospital
      • Contact: Jie Zhang, director; Phone Number: +8615822798742; Email: wzq_bf@163.com
      • Contact: Ruoyu Jiang, collegue; Phone Number: +8618622632394; Email: jiangruoyu000@aliyun.com
  • Zhejiang
    • Hangzhou, Zhejiang, China, 0571
      • Recruiting
      • Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Jifan Chen, collegue; Phone Number: +8613605771565; Email: chenjifan0619@163.com
• Ukraine
  • Kharkiv, Ukraine, 61024
    • Not yet recruiting
    • Interventional Oncology Centre, State Institution "Grigoriev Intstitute for Medical Radiology NAMS of Ukraine"
    • Contact: Sviatoslav Balaka; Phone Number: +380509356958; Email: balaka.svjat@gmail.com
    • Contact: Hennadii Hrechikhin; Phone Number: +380509188586; Email: interv.oncology@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiofrequency Ablation; Eligible participants with PTMC will be randomly assigned to this group and undergo radiofrequency ablation(RFA) procedure.	Procedure: Radiofrequency Ablation; Patients were supine with the neck exposure completely during the procedure. Local anesthesia with 1% lidocaine was injected at the subcutaneous puncture site and the thyroid anterior capsule. If the distance between the tumor and critical cervical structures was less than 5 mm, normal saline was injected to form at least 1 cm distance between the tumor and the critical structure to prevent the unwilling thermal injury. RFA was performed using the moving-shot technique and RFA power was 5 W, if a transient hyperechoic zone did not form at the electrode tip within 5-10 seconds. The RFA extent exceeded the tumor edge to prevent marginal residue and recurrence. The ablation was terminated when all portions of the target ablation area had changed to hyperechoic zones.; Other Names: RFA
Active Comparator: Conventional Surgery; Eligible participants with PTMC will be randomly assigned to this group and undergo total/thyroid lobectomy procedure.	Procedure: Conventional Surgery; Patient is performed total thyroidectomy or thyroid lobectomy depending on the intraoperative situation, disease condition and comprehensive judge by surgeon. Patients are routinely disinfected and spread the drapes after general anesthesia. Neck skin, fat and placenta muscle are incised and separated successively. The flap is separated to the upper edge of thyroid cartilage, neck white line is incised and anterior muscle group is separated. Then both sides thyroid lobes are exposed. Cut off the isthmus, ligature the thyroid artery, cut off the upper pole. Ligature and cut off the ipsilateral thyroid vein. Reveal and protect the ipsilateral recurrent laryngeal nerve and the parathyroid gland during the entire process.; Other Names: Total thyroidectomy/Thyroid lobectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent-free Survival Rate	record detecting recurrence of PTMC post-surgery or post-FRA	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Diameter of Lesion	record diameter reduce rate after RFA procedure	5 years
The Volume of Lesion	record volume reduce rate after RFA procedure	5 years
Postoperative Complications	record relevant complications after surgery or RFA	up to 12 months
Serum Concentration of Serological Examination of Thyroid Function	record the serum concentration of TSH/T3/FT3/T4/FT4/TPOAb/TgAb/TRAb.	up to 12 months
Medical Cost	record hospital expenditure	up to 12 months
Hospital Duration	record hospital stay time	through study completion, an average of 7 days
Patient Satisfaction: questionnaire	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.	5 years
Anxiety index measured by psychological questionnaire	I feel more nervous and anxious than usual (anxiety); I feel scared for no reason (fear); I am easily upset or frightened (frightened); 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)	up to 5 years
Overall Survival in Patients with PTMC	record 5 year overall survival	5 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Pintong Huang, director, Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: January 13, 2019
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Surgery; Radiofrequency Ablation; Papillary Thyroid Microcarcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Thyroid Diseases; Thyroid Neoplasms; Carcinoma, Papillary
• Other Study ID Numbers: 2013-004-A012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No