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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

757 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2024-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Papillary Thyroid Microcarcinoma Radiofrequency Ablation Surgical Resection Long-term Outcomes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Radiofrequency ablation

Radiofrequency ablation alone

Intervention Type 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

Intervention Type 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

Interventions

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Radiofrequency ablation alone

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.

Intervention Type PROCEDURE

surgical resection

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.