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.
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,.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
79
sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.
CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital
Beijing, Beijing Municipality, China
Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to Kidney Development Improvement Global Outcome (KDIGO) Guidelines.
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.
Time frame: 12 months
Incidence of Injury on the Recurrent Laryngeal Nerve (RLN).
Comparison of the incidence of RLN injury between ultrasonic ablation group and parathyroidectomy group.
Time frame: 12 months
Changes of the Blood Levels on Calcium During 12 Months.
The blood levels of calcium will be detected at least once every 3 months and will be compared to the baseline levels.
Time frame: Baseline and 12 months
Changes of Blood Levels on Phosphorus During 12 Months.
The blood levels of phosphorus will be detected at least once every 3 months and will be compared to the baseline levels.
Time frame: Baseline and 12 months
Changes of Blood Levels on iPTH During 12 Months.
The blood levels of iPTH will be detected at least once every 3 months and will be compared to the baseline levels.
Time frame: Baseline and 12 months
Changes of Blood Levels on Bone Specific Alkaline Phosphatase.
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.
Time frame: Baseline and 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.