10 Years' Follow-up Results of Ultrasound-guided Radiofrequency Ablation Versus Surgery for Low-risk Papillary Thyroid Micro-carcinoma

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.

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Key information

Conditions

Papillary Thyroid Microcarcinoma Long-term Outcomes Radiofrequency Ablation Surgical Resection

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(a) 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.

Exclusion criteria

(a) severe coagulation disorder or organ failure, (b) evidence of an aggressive sub-type of PTC on biopsy, and (c) incomplete data.

Treatment and study plan

Radiofrequency ablation alone

Procedure

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 resection

Procedure

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Yi Mao

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2024
First posted: Aug 6, 2025
Registry last updated: Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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