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

Not Applicable

Completed

Interventions: Procedure: Ultrasonic ablation
Procedure: Parathyroidectomy
Drug: Active vitamin D

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,.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Ultrasonic ablation	Ultrasonic ablation	Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.
Parathyroidectomy	Parathyroidectomy	Patients in parathyroidectomy group will be treated by parathyroid surgery.
Active vitamin D	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.

Primary Outcome Measures

Name	Time	Method
Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to Kidney Development Improvement Global Outcome (KDIGO) Guidelines.	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of Injury on the Recurrent Laryngeal Nerve (RLN).	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.	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.	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.	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.	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.