Papillary Thyroid MicrocarcinomaNCT03808779
A Multicenter Trial of Radiofrequency Ablation vs. Surgery as Treatment of Papillary Thyroid Microcarcinoma.
A study testing Radiofrequency Ablation and Conventional Surgery in people with Papillary Thyroid Microcarcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papillary Thyroid Microcarcinoma
- What is being tested?
- Radiofrequency Ablation and Conventional Surgery
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jun 2019to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
China2 sites, 2 recruiting
- Recruiting
Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 0571
Pintong Huang, director, +8618857168333, huangpintong@126.com
Jifan Chen, collegue, +8613605771565, chenjifan0619@163.com
- Recruiting
General Surgery Department, Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 022
Jie Zhang, director, +8615822798742, wzq_bf@163.com
Ruoyu Jiang, collegue, +8618622632394, jiangruoyu000@aliyun.com
Ukraine1 site, 1 recruiting
- Not yet recruiting
Interventional Oncology Centre, State Institution "Grigoriev Intstitute for Medical Radiology NAMS of Ukraine"
Kharkiv, 61024
Sviatoslav Balaka, +380509356958, balaka.svjat@gmail.com
Hennadii Hrechikhin, +380509188586, interv.oncology@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Papillary Thyroid Microcarcinoma
- Being tested
- Radiofrequency Ablation, Conventional Surgery
- Keywords
- Papillary Thyroid Microcarcinoma, Radiofrequency Ablation, Surgery
- Medical subject headings
- Papillary Thyroid Microcarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency AblationProcedure or surgery
Also called RFA
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.
Conventional SurgeryProcedure or surgery
Also called Total thyroidectomy/Thyroid lobectomy
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.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency Ablation | Experimental | Eligible participants with PTMC will be randomly assigned to this group and undergo radiofrequency ablation(RFA) procedure. Receives: Procedure: Radiofrequency Ablation |
| Conventional Surgery | Active comparator | Eligible participants with PTMC will be randomly assigned to this group and undergo total/thyroid lobectomy procedure. Receives: Procedure: Conventional Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent-free Survival Rate
record detecting recurrence of PTMC post-surgery or post-FRA
Measured: 5 years
Secondary outcomes (9)
The Diameter of Lesion
record diameter reduce rate after RFA procedure
Measured: 5 years
The Volume of Lesion
record volume reduce rate after RFA procedure
Measured: 5 years
Postoperative Complications
record relevant complications after surgery or RFA
Measured: 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.
Measured: up to 12 months
Medical Cost
record hospital expenditure
Measured: up to 12 months
Hospital Duration
record hospital stay time
Measured: 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.
Measured: 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)
Measured: up to 5 years
Overall Survival in Patients with PTMC
record 5 year overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start1 Jun 2019
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Thyroid MicrocarcinomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, huang pintong, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Pintong Huang, director, Principal investigator, Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808779
- Sponsor's protocol ID
- 2013-004-A012
- Status last verified
- Dec 2020
- First submitted
- 13 Jan 2019
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized and Controlled Trial of Radiofrequency Ablation vs. Conventional Surgery as Treatment of Papillary Thyroid Microcarcinoma (PTMC)
- ClinicalTrials.gov ID
- NCT03808779
- Acronym / sponsor ID
- 2013-004-A012
- Conditions
- Papillary Thyroid Microcarcinoma
- Keywords
- Papillary Thyroid Microcarcinoma, Radiofrequency Ablation, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency Ablation | Experimental | Procedure: Radiofrequency AblationEligible participants with PTMC will be randomly assigned to this group and undergo radiofrequency ablation(RFA) procedure. |
| Conventional Surgery | Active comparator | Procedure: Conventional SurgeryEligible participants with PTMC will be randomly assigned to this group and undergo total/thyroid lobectomy procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- Multifocal PTMC
- Combined with other types of thyroid cancer or hyperthyroidism.
- Contralateral vocal cord paralysis
- With local or distant metastasis
- Pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency AblationAlso: RFAPatients 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. | Procedure or surgery | Radiofrequency Ablation |
| Conventional SurgeryAlso: Total thyroidectomy/Thyroid lobectomyPatient 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. | Procedure or surgery | Conventional Surgery |
Primary outcome
Recurrent-free Survival Rate
Time frame: 5 years
record detecting recurrence of PTMC post-surgery or post-FRA
9 secondary outcomes
The Diameter of Lesion
Time frame: 5 years
The Volume of Lesion
Time frame: 5 years
Postoperative Complications
Time frame: up to 12 months
Serum Concentration of Serological Examination of Thyroid Function
Time frame: up to 12 months
Medical Cost
Time frame: up to 12 months
Hospital Duration
Time frame: through study completion, an average of 7 days
Patient Satisfaction: questionnaire
Time frame: 5 years
Anxiety index measured by psychological questionnaire
Time frame: up to 5 years
Overall Survival in Patients with PTMC
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Individual participant dataSharing planned: Undecided
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RFA Treatment for Papillary Thyroid Microcarcinoma
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Decision Aid Efficacy in Low Risk Thyroid Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pintong Huang, director principal investigator
Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency Ablation and Conventional Surgery in people with Papillary Thyroid Microcarcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pintong Huang, director (+8618857168333, huangpintong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent-free Survival Rate (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.