Study of the Efficacy and Safety on the Ultrasonic Ablation Treatment for Secondary Hyperthyroidism in Chronic Kidney Disease Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to Kidney Development Improvement Global Outcome (KDIGO) Guidelines.
研究概览
简要总结
It is difficulty for the treatment of secondary hyperparathyroidism in the chronic kidney disease (CKD) patients who had not succeeded medical therapy and could not get parathyroidectomy. The investigators suppose that ultrasonic ablation may be a valuable alternative treatment that help control secondary hyperparathyroidism in CKD patients presenting with enlarged parathyroid gland(s) visible at ultrasonography.
详细描述
Secondary hyperparathyroidism (sHPT) is common in patients with chronic kidney disease (CKD), including those who are undergoing long-term dialysis treatments. sHPT is damaged for bone system, blood system, cardiovascular system, and so on. The treatment of the sHPT of CKD's patient includes dietary phosphate restriction, the use of medicines, and parathyroidectomy. In the mainland of China, there are not certain useful medicines to treat sHPT, including the derivatives of vitamin D, calcimimetic agent, non calcium aluminum phosphate binders. Furthermore, medical therapy is not always successful in achieving adequate control of sHPT. Oral medications have efficacy limitations as well as side-effects. Otherwise, surgery treatment can only be used for the patients with enlarged parathyroid gland(s). The patients may suffer from the injury of operation, hypoparathyroidism, or recurrence of hyperparathyroidism after parathyroidectomy.
Then ultrasonic ablation may become a valuable alternative treatment that help control sHPT in selected patients presenting with enlarged parathyroid gland(s) visible at ultrasonography,.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with age between 18 - 75 years.
- •Patients with parathyroid nodular or diffuse hyperplasia demonstrated on ultrasound imaging or radioisotope scan.
- •CKD patients in stage 5, with elevated intact parathyroid hormone (iPTH) levels > 800pg/mL.
- •CKD patients have been followed up more than 6 months.
排除标准
- •Primary or Tertiary Hyperparathyroidism (hyperparathyroidism after kidney transplantation).
- •Patient who underwent total parathyroidectomy and without enlarged parathyroid gland(s).
- •Known history of parathyroid or other neoplasias in the neck region.
- •History of neck irradiation.
- •Major surgery of neck in the last 3 months or other major surgery projected in the subsequent 4 months.
- •Pregnant or lactating woman.
- •Patient receiving drugs such as phenobarbital, phenytoin, rifampicin, sucralfate, steroids, flecainide, thioridazine, or most tricyclic antidepressants which could affect vitamin D metabolism.
- •Treatment with vitamin D derivatives, cinacalcet or other calcimimetics within the past 6 months.
- •Patients who are currently participating in another clinical trial.
- •The expected live time is less than 1 year.
- •Patients suffered from acute myocardial infraction, acute congestive heart failure, or stroke in last 6 months.
- •Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.
研究组 & 干预措施
Active vitamin D
Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in Kidney Developement Improvement Global Outcomes (KDIGO) guidelines.
干预措施: Active vitamin D (Drug)
Ultrasonic ablation
Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.
干预措施: Ultrasonic ablation (Procedure)
Parathyroidectomy
Patients in parathyroidectomy group will be treated by parathyroid surgery.
干预措施: Parathyroidectomy (Procedure)
结局指标
主要结局
Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to Kidney Development Improvement Global Outcome (KDIGO) Guidelines.
时间窗: 12 months
The blood levels of intact parathyroid hormone (iPTH) will be detected every 3 months for stable patients. The blood test will be more frequent, at least once per-month, after the ultrasonic ablation treatment, surgery, or during the impulse therapy of active vitamin D with large doses.
次要结局
- Incidence of Injury on the Recurrent Laryngeal Nerve (RLN).(12 months)
- Changes of the Blood Levels on Calcium During 12 Months.(Baseline and 12 months)
- Changes of Blood Levels on Phosphorus During 12 Months.(Baseline and 12 months)
- Changes of Blood Levels on iPTH During 12 Months.(Baseline and 12 months)
- Changes of Blood Levels on Bone Specific Alkaline Phosphatase.(Baseline and 12 months)
研究者
Dongliang Zhang, MD
associate professor
Capital Medical University