Clinical Trial: Efficacy and Safety of Ultrasonic Ablation to Treat Secondary Hyperparathyroidism in Chronic Kidney Disease Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Study of the Efficacy and Safety on the Ultrasonic Ablation Treatment for Secondary Hyperthyroidism in Chronic Kidney Disease Patients.

Brief Summary: 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.

Detailed Summary:

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,.


Sponsor: Dongliang Zhang, MD

Current Primary Outcome: Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to Kidney Development Improvement Global Outcome (KDIGO) Guidelines. [ Time Frame: 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.


Original Primary Outcome: Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to KDIGO Guidelines. [ Time Frame: 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 ultasonic ablation treatment, surgery, or during the impulse therapy of active vitamin D with large doses.


Current Secondary Outcome:

  • Incidence of Injury on the Recurrent Laryngeal Nerve (RLN). [ Time Frame: 12 months ]
    Comparison of the incidence of RLN injury between ultrasonic ablation group and parathyroidectomy group.
  • Changes of the Blood Levels on Calcium During 12 Months. [ Time Frame: Baseline and 12 months ]
    The blood levels of calcium will be detected at least once every 3 months and will be compared to the baseline levels.
  • Changes of Blood Levels on Phosphorus During 12 Months. [ Time Frame: Baseline and 12 months ]
    The blood levels of phosphorus will be detected at least once every 3 months and will be compared to the baseline levels.
  • Changes of Blood Levels on iPTH During 12 Months. [ Time Frame: Baseline and 12 months ]
    The blood levels of iPTH will be detected at least once every 3 months and will be compared to the baseline levels.
  • Changes of Blood Levels on Bone Specific Alkaline Phosphatase. [ Time Frame: Baseline and 12 months ]
    The blood levels of bone specific alkaline phosphatase will be detected at least once every 3 months and will be compared to the baseline levels.


Original Secondary Outcome:

  • Detection of the vascular and valve calcification. [ Time Frame: 12 months ]
    Chest radiography will be done to calculate the aortic arch calcification score (AoACS) at both baseline and the 12th month. Echocardiogram will aslo be proceeded to detect the valve calcification at two time point.
  • Change in subjective global assessment (SGA). [ Time Frame: Month 0, 6, and 12 ]
    Comparation of the SGA scores among month 6 and month 12 to baseline.
  • Incidence of Injury on the Recurrent Laryngeal Nerve (RLN). [ Time Frame: 12 months ]
    Comparation of the incidence of RLN injury between ultrasonic ablation group and parathyroidectomy group.
  • Changes of the Blood Levels on Calcium During 12 Months. [ Time Frame: 12 months ]
    The blood levels of calcium will be detected at least once every 3 months and will be compared to the baseline levels.
  • Changes of Blood Levels on Phosphorus During 12 Months. [ Time Frame: 12 months ]
    The blood levels of phosphorus will be detected at least once every 3 months and will be compared to the baseline levels.
  • Changes of Blood Levels on iPTH During 12 Months. [ Time Frame: 12 months ]
    The blood levels of iPTH will be detected at least once every 3 months and will be compared to the baseline levels.
  • Changes of Blood Levels on Bone Specific Alkaline Phosphatase. [ Time Frame: 12 months ]
    The blood levels of bone specific alkaline phosphatase will be detected at least once every 3 months and will be compared to the baseline levels.


Information By: Capital Medical University

Dates:
Date Received: July 9, 2012
Date Started: August 2012
Date Completion:
Last Updated: August 23, 2016
Last Verified: August 2016