Clinical trial NCT01640184
Conditions: Hyperparathyroidism Disorders of Parathyroid Gland
Keywords: hyperparathyroidism vitamin D ultrasonic ablation surgery
Sponsor: Dongliang Zhang, MD
Start date: 2012-08-01; Completion date: 2014-11-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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 description:
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,.

Arms: arm 1: 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. arm 2: Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. arm 3: Patients in parathyroidectomy group will be treated by parathyroid surgery.
Interventions: intervention 1: Parathyroidectomy intervention 2: Active vitamin D intervention 3: Ultrasonic ablation
Intervention descriptions: intervention 1: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery. intervention 2: 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. intervention 3: 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.

Protocol documents: