Ultrasound and Gene-Guided Microwave Ablation Versus Surgery for Low-Risk Papillary Thyroid Carcinoma: a Prospective Observational Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Disease progression
研究概览
简要总结
This study aims to investigate the efficacy and prognosis of ultrasound-guided and gene-based microwave ablation (MWA) versus surgical treatment in patients with low-risk papillary thyroid carcinoma (PTC). By analyzing genetic testing results, the study explores the impact of genetic mutations on treatment selection for low-risk patients, providing more precise molecular biological evidence for treatment choices and prognosis evaluation of thyroid cancer. This prospective study collects clinical data from patients diagnosed with PTC at Sun Yat-sen Memorial Hospital of Sun Yat-sen University between January 2022 and November 2024, who underwent genetic testing prior to treatment, and assesses efficacy and complications through long-term follow-up.
详细描述
Objective
This study evaluates and compares the efficacy and prognosis of ultrasound and gene-based microwave ablation (MWA) and surgical treatment in patients with low-risk papillary thyroid carcinoma (PTC), emphasizing the influence of genetic mutations on low-risk patients' selection.
Background: MWA, a minimally invasive technique, is increasingly recognized in the management of PTC. While traditional criteria for ablation focus on tumor size, number, and location, the impact of genetic mutations on treatment efficacy remains underexplored.
Methods: A total of 201 patients with low-risk PTC without metastasis were prospectively enrolled. All patients underwent ultrasound and next-generation sequencing to confirm low-risk status. Patients chose either ablation or surgery and were monitored until November 2024. Efficacy and complications were assessed using thyroid ultrasound and contrast-enhanced ultrasound.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Disease progression
时间窗: through study completion, an average of 1 year
The primary endpoint was disease progression, defined as: (1) local recurrence or cervical lymph node metastasis confirmed by FNA; (2) Distant organ metastasis; (3) Death due to tumor progression.
次要结局
- Complications(through study completion, an average of 1 year)
- Treatment costs(through study completion, an average of 1 year)
- Time of hospital stay(from admission to discharge, up to 1 week.)
- Operative time(immediately after the intervention)
- Ablation efficacy(Follow-up examination one month after treatment.)
- Changes in ablation zone volume(through study completion, an average of 1 year)
- Thyroid function(through study completion, an average of 1 year)
研究者
Longmiaoyun
Chief Physician
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University