Thermal Ablation Versus Parathyroidectomy for Secondary 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
- 612
- 主要终点
- Achievement rate of target PTH value
研究概览
简要总结
Secondary hyperparathyroidism (SHPT), which is frequently associated with chronic kidney disease, leads to problems such as bone pain, fractures, and cardiovascular issues, thereby affecting patients' quality of life. This clinical trial is designed to compare the efficacy of thermal ablation and surgical treatment for SHPT. Parameters including parathyroid hormone levels, serum calcium and phosphorus levels, SHPT-related symptoms (for example, bone pain, muscle weakness), and complication occurrence will be monitored. The advantages involve enabling better treatment decisions for patients, enhancing patients' quality of life, and alleviating the burden on families, in addition to augmenting the clinical knowledge of healthcare providers. However, both treatments carry risks. Thermal ablation may have problems like incomplete ablation, local tissue damage, and blood parameter changes. Surgical risks comprise bleeding, infection, adjacent tissue damage (such as the recurrent laryngeal nerve), and hypoparathyroidism. The investigators will strive to minimize these risks. This trial is of great significance for SHPT treatment, and the investigators welcome participants to contribute to the advancement of medical science in this area.
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
- •persistent serum iPTH (intact parathyroid hormone) levels > 800 pg/mL;
- •resistance to calcimimetics, vitamin D, and its analogs, with ineffective conventional internal medicine comprehensive treatment;
- •severe bone pain, osteoporosis, muscle pain, ectopic soft tissue calcification, or other factors affecting quality of life;
- •imaging examinations indicating the presence of at least one enlarged parathyroid gland
排除标准
- •severe bleeding tendency or coagulation disorders, severe cardiopulmonary abnormalities, and abnormal vital signs such as severe hypertension, arrhythmias, and anemia
结局指标
主要结局
Achievement rate of target PTH value
时间窗: 6 months after surgery or ablation
Symptom remission rate
时间窗: 1 year after treatment
The symptom remission rate refers to the proportion of the number of patients whose symptoms have been alleviated to the total number of patients treated in the treatment of primary hyperparathyroidism, either by surgery or ablation.
次要结局
- complication rate(within 30 days after surgery or ablation)
- Normalization Probability of Serum Calcium and Phosphorus after Ablation or Surgery(6 months post-treatment)
- Bone mineral density change(2 years)
- Assessment of Changes in Bone Metabolism Markers Including BALP, PINP, and ALP for Treating Primary Hyperparathyroidism by Surgery and Ablation(1 year)
- All - cause mortality rate(2 years)
研究者
Ping Liang
Professor
Chinese PLA General Hospital
