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临床试验/NCT06709586
NCT06709586尚未招募不适用

Thermal Ablation Versus Parathyroidectomy for Secondary Hyperparathyroidism: a Multicenter Study

Chinese PLA General Hospital0 个研究点目标入组 612 人开始时间: 2024年11月26日最近更新:
适应症

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

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

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ping Liang

Professor

Chinese PLA General Hospital

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