Papillary Thyroid MicrocarcinomaNCT07107503
10 Years' Follow-up Results of Ultrasound-guided Radiofrequency Ablation Versus Surgery for Low-risk Papillary Thyroid Micro-carcinoma
An observational study of Papillary Thyroid Microcarcinoma and Radiofrequency Ablation, run by Yi Mao.
Trial summary
Papillary thyroid micro-carcinoma (PTMC) generally demonstrates favorable prognosis. However, the potential risk of disease progression requires careful therapeutic consideration. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Papillary Thyroid Microcarcinoma, Radiofrequency Ablation, Surgical Resection
- What is being tested?
- Radiofrequency ablation alone and surgical resection
- Type of treatment
- Surgery or procedure
- How many people
- 757 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Dec 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This retrospective multi-center study included patients with PTMC treated at four university-affiliated hospitals in China from April 2011 to December 2014.
Who may be able to join
- PTC confirmed at FNA or CNB, with a maximum diameter of 1 cm; (b) no clinical or imaging evidence of extra-thyroidal extension (41-42) and no evidence of metastasis at preoperative ultrasonography (US) or neck computed tomography (CT), indicating clinical preoperative T1aN0M0; (c) no history of neck irradiation; (d) no prior thyroid surgery; (e) follow-up of ≥ 120 months.
Who cannot join
- severe coagulation disorder or organ failure, (b) evidence of an aggressive sub-type of PTC on biopsy, and (c) incomplete data.
About this study
Papillary thyroid micro-carcinoma (PTMC) generally demonstrates favorable prognosis. However, the potential risk of disease progression requires careful therapeutic consideration. Radiofrequency ablation (RFA) has garnered attention as a minimally invasive treatment option for patients with PTMC who choose to decline both surgical resection (SR) and active surveillance. However, comprehensive comparative studies evaluating RFA versus surgery regarding long-term oncological efficacy, quality-of-life, and cost-effectiveness in multicenter cohorts remain warranted. To compare the oncological outcomes, quality of life, and cost-effectiveness between RFA and SR for low-risk PTMC over 10 years' follow-up.
- Conditions
- Papillary Thyroid Microcarcinoma, Radiofrequency Ablation, Surgical Resection, Long-term Outcomes
- Being tested
- Radiofrequency ablation alone, surgical resection
- 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 ablation aloneProcedure or surgery
RFA was performed by four US physicians with ≥ 10 years of experience in in-terventional US. Before ablation, the patients were placed in the supine position with the neck extended, and local anesthesia was administered with lidocaine (1%). RFAs were performed using the hydro-dissection, trans-isthmic and moving-shot techniques according to previously published guidelines. Ablation was terminated when the target tumor changed to a transient hyperechoic zone. Contrast-enhanced US (CEUS) was performed immediately after ablation to evaluate the ablation area. The presence of complications during or after thermal ablation and corresponding treatments was carefully evaluated. All patients were closely observed for 1-2 h after ablation in the hospital.
surgical resectionProcedure or surgery
SR was performed under general anesthesia by surgeons with>15 years of expe-rience in thyroid surgery. The decision to perform total thyroidectomy or lobectomy was made by individual surgeons and patients, based on patient preferences in consu
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation | Not described Receives: Procedure: Radiofrequency ablation alone | |
| surgical resection | Not described Receives: Procedure: surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor progression
Tumor progression included (1) local recurrence confirmed by biopsy, (2) new PTMC tumors confirmed by biopsy, (3) LN metastasis confirmed by biopsy, and (4) distant metastases.
Measured: The RFA group follow-ups were conducted at 1, 3, 6, 12, and every 12 months thereafter. The SR group follow-ups were conducted at 1, 6, 12 and every 12 months thereafter. All the patients finished at least 10-year follow-ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study startApr 2011
- Primary completionDec 2014
- Study completionDec 2024
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 757 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yi Mao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Mao, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107503
- Sponsor's protocol ID
- ChinaPLAGH202506
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 10 Years' Follow-up Results of Ultrasound-guided Radiofrequency Ablation Versus Surgery for Low-risk Papillary Thyroid Micro-carcinoma
- ClinicalTrials.gov ID
- NCT07107503
- Acronym / sponsor ID
- ChinaPLAGH202506
- Conditions
- Papillary Thyroid Microcarcinoma, Radiofrequency Ablation, Surgical Resection, Long-term Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 757 participants (actual)
- Lead sponsor
- Yi MaoUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2024 (actual)
- First posted
- 6 Aug 2025 (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.
Papillary thyroid micro-carcinoma (PTMC) generally demonstrates favorable prognosis. However, the potential risk of disease progression requires careful therapeutic consideration. Radiofrequency ablation (RFA) has garnered attention as a minimally invasive treatment option for patients with PTMC who choose to decline both surgical resection (SR) and active surveillance. However, comprehensive comparative studies evaluating RFA versus surgery regarding long-term oncological efficacy, quality-of-life, and cost-effectiveness in multicenter cohorts remain warranted. To compare the oncological outcomes, quality of life, and cost-effectiveness between RFA and SR for low-risk PTMC over 10 years' follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation | – | Procedure: Radiofrequency ablation alone |
| surgical resection | – | Procedure: surgical resection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This retrospective multi-center study included patients with PTMC treated at four university-affiliated hospitals in China from April 2011 to December 2014.
Key inclusion criteria (1 listed)
- PTC confirmed at FNA or CNB, with a maximum diameter of 1 cm; (b) no clinical or imaging evidence of extra-thyroidal extension (41-42) and no evidence of metastasis at preoperative ultrasonography (US) or neck computed tomography (CT), indicating clinical preoperative T1aN0M0; (c) no history of neck irradiation; (d) no prior thyroid surgery; (e) follow-up of ≥ 120 months.
Key exclusion criteria (1 listed)
- severe coagulation disorder or organ failure, (b) evidence of an aggressive sub-type of PTC on biopsy, and (c) incomplete data.
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 ablation aloneRFA was performed by four US physicians with ≥ 10 years of experience in in-terventional US. Before ablation, the patients were placed in the supine position with the neck extended, and local anesthesia was administered with lidocaine (1%). RFAs were performed using the hydro-dissection, trans-isthmic and moving-shot techniques according to previously published guidelines. Ablation was terminated when the target tumor changed to a transient hyperechoic zone. Contrast-enhanced US (CEUS) was performed immediately after ablation to evaluate the ablation area. The presence of complications during or after thermal ablation and corresponding treatments was carefully evaluated. All patients were closely observed for 1-2 h after ablation in the hospital. | Procedure or surgery | Radiofrequency ablation |
| surgical resectionSR was performed under general anesthesia by surgeons with>15 years of expe-rience in thyroid surgery. The decision to perform total thyroidectomy or lobectomy was made by individual surgeons and patients, based on patient preferences in consu | Procedure or surgery | surgical resection |
Primary outcome
Tumor progression
Time frame: The RFA group follow-ups were conducted at 1, 3, 6, 12, and every 12 months thereafter. The SR group follow-ups were conducted at 1, 6, 12 and every 12 months thereafter. All the patients finished at least 10-year follow-ups.
Tumor progression included (1) local recurrence confirmed by biopsy, (2) new PTMC tumors confirmed by biopsy, (3) LN metastasis confirmed by biopsy, and (4) distant metastases.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Papillary Thyroid Microcarcinoma and Radiofrequency Ablation, run by Yi Mao.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor progression (time frame: The RFA group follow-ups were conducted at 1, 3, 6, 12, and every 12 months thereafter. The SR group follow-ups were conducted at 1, 6, 12 and every 12 months thereafter. All the patients finished at least 10-year follow-ups.). 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 6 Aug 2025.