跳至主要内容
临床试验/NCT07107503
NCT07107503已完成不适用

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

Yi Mao0 个研究点目标入组 757 人开始时间: 2011年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
757
主要终点
Tumor progression

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •(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.

排除标准

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

结局指标

主要结局

Tumor progression

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Yi Mao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yi Mao

clinician

Chinese PLA General Hospital

相似试验

10 Years' Follow-up Results of Ultrasound-guided... | 临床试验