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)
1 other identifier
interventional
200
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2019
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2019
CompletedFirst Posted
Study publicly available on registry
January 18, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedDecember 19, 2020
December 1, 2020
4.7 years
January 13, 2019
December 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrent-free Survival Rate
record detecting recurrence of PTMC post-surgery or post-FRA
5 years
Secondary Outcomes (9)
The Diameter of Lesion
5 years
The Volume of Lesion
5 years
Postoperative Complications
up to 12 months
Serum Concentration of Serological Examination of Thyroid Function
up to 12 months
Medical Cost
up to 12 months
- +4 more secondary outcomes
Study Arms (2)
Radiofrequency Ablation
EXPERIMENTALEligible participants with PTMC will be randomly assigned to this group and undergo radiofrequency ablation(RFA) procedure.
Conventional Surgery
ACTIVE COMPARATOREligible participants with PTMC will be randomly assigned to this group and undergo total/thyroid lobectomy procedure.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
General Surgery Department, Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 022, China
Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 0571, China
Interventional Oncology Centre, State Institution "Grigoriev Intstitute for Medical Radiology NAMS of Ukraine"
Kharkiv, 61024, Ukraine
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pintong Huang, director
Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Department of Ultrasound, Professor of Zhejiang University School of Medicine
Study Record Dates
First Submitted
January 13, 2019
First Posted
January 18, 2019
Study Start
June 1, 2019
Primary Completion
February 1, 2024
Study Completion
February 1, 2024
Last Updated
December 19, 2020
Record last verified: 2020-12