Hybrid Endoscopic Hemithyroidectomy and Targeted Ablation for Bilateral Papillary Thyroid Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Structural Recurrence-Free Survival
研究概览
简要总结
This study evaluates a thyroid-function-preserving alternative to routine total thyroidectomy for bilateral papillary thyroid carcinoma (PTC). Eligible adults undergo remote-access gas-less axillo-breast endoscopic hemithyroidectomy with level VI dissection on the dominant side, followed by ultrasound-guided radiofrequency ablation (RFA) of a ≤7 mm contralateral focus during the same anesthesia. Outcomes include structural-recurrence-free survival, endocrine-function preservation, safety, and quality of life over 24 months.
详细描述
Bilateral PTC traditionally prompts total thyroidectomy, exposing patients to lifelong thyroxine replacement and a 1 - 3 % risk of permanent hypocalcemia. Building on a pilot cohort of 11 patients treated from June 2018 to September 2024 that showed no structural recurrence, no permanent RLN palsy, and preserved endocrine function after a median 17-month follow-updraft_Proof_hi, we launch a multicenter registry to confirm oncologic adequacy and functional benefits. Intervention: endoscopic hemithyroidectomy (dominant lobe) via gas-less axillo-breast approach plus central-neck dissection; then contralateral lesion RFA with a 17-gauge 0.7-cm active-tip electrode at 40 W (moving-shot). Follow-up at 1, 6, 12, 18, and 24 months includes ultrasound, serum Tg, calcium, PTH, and QoL instruments. Long-term surveillance continues annually to five years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years.
- •Dominant-side PTC ≤1.5 cm suitable for endoscopic resection.
- •Contralateral nodule ≤7 mm located ≥2 mm from posterior capsule.
- •No radiologic lymph-node metastasis on contralateral side.
- •Written informed consent.
排除标准
- •Extrathyroidal extension, gross nodal or distant metastasis.
- •Prior neck surgery, prior RFA/ethanol injection, or neck irradiation.
- •Pregnancy or lactation.
- •Serious comorbidities precluding anesthesia or follow-up.
结局指标
主要结局
Structural Recurrence-Free Survival
时间窗: 24 months
Proportion of participants without local, regional, or distant structural recurrence confirmed by imaging ± cytopathology.
Endocrine-Function Preservation
时间窗: 24 months
Participants alive and free from lifelong levothyroxine therapy and permanent hypocalcemia (serum Ca ≥2.1 mmol/L without supplementation).
次要结局
- Permanent RLN Palsy Incidence(12 months)
- Permanent Hypocalcemia Incidence(12 months)
- Nodule Volume Reduction Rate(12 months)
- Procedure-Related Adverse Events(30 days)
研究者
Bo Wang,MD
Director, Head of Thyroid Surgery, Principal Investigator, Clinical Professor
Fujian Medical University