Thermal Ablation Versus Parathyroidectomy for Primary Hyperparathyroidism: a Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 520
- 主要终点
- cure rate
研究概览
简要总结
This study is a prospective, multicenter study designed to compare the efficacy and safety of surgical treatment versus ablation therapy (including radiofrequency ablation and microwave ablation) for patients with primary hyperparathyroidism (PHPT). The study will assess the impact of both treatment modalities on serum parathyroid hormone (iPTH) and calcium levels, clinical symptom improvement, bone mineral density enhancement, reduction in the incidence of urinary system stones, and postoperative complication rates. While surgical treatment has been the standard of care for PHPT, offering definitive cure, it carries inherent surgical risks and complications. Ablation therapy, as a minimally invasive approach, presents a novel alternative with reduced trauma and fewer complications. The outcomes of this study will inform clinical decision-making and potentially optimize treatment strategies for patients with PHPT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic patients with primary hyperparathyroidism, such as those with symptoms in any system including the kidneys, bones, gastrointestinal tract, psychoneurological system, or those with atypical symptoms such as muscle weakness, dysfunction, and sleep disorders.
- •Asymptomatic PHPT patients with any of the following conditions:
- •① Serum calcium is higher than the upper limit of the normal value by 1 mg/dL (0.25 mmol/L);
- •② There is objective evidence of renal involvement, including asymptomatic kidney stones, nephrocalcinosis, hypercalciuria (24 - hour urinary calcium level > 400 mg/dL) on renal imaging, or impaired renal function (glomerular filtration rate < 60 mL/min);
- •③ There is evidence of osteoporosis (bone mineral density decreased by 2.5 standard deviations at any site) and/or radiographic evidence of fragility fractures.
- •④ Age < 50 years
- •⑤ The patient cannot accept routine follow - up observation.
- •Imaging examination shows that at least one parathyroid gland is enlarged.
排除标准
- •diagnosis of secondary or tertiary HPT
- •severe coagulation disorder
- •severe cardiopulmonary insufficiency
结局指标
主要结局
cure rate
时间窗: 6 months after surgery or ablation
The cure rate is the probability that postoperative levels of parathyroid hormone (PTH) and blood calcium reach the target values.
次要结局
- complication rate(within 30 days after surgery or ablation)
- symptom remission rate(1 year after treatment initiation)
- Normalization Probability of Serum Calcium and Phosphorus after Ablation or Surgery(6 months post-treatment)
- Bone mineral density change(2 years)
研究者
Ping Liang
Professor
Chinese PLA General Hospital