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

Dongliang Zhang, MD

Status

Completed

Conditions

Hyperparathyroidism

Disorders of Parathyroid Gland

Treatments

Procedure: Parathyroidectomy

Drug: Active vitamin D

Procedure: Ultrasonic ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT01640184

2012-079

Z121107001012138 (Other Grant/Funding Number)

2001-2002-02 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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,.

Enrollment

79 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

79 participants in 3 patient groups

Active vitamin D

Active Comparator group

Description:

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.

Treatment:

Drug: Active vitamin D

Ultrasonic ablation

Experimental group

Description:

Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.

Treatment:

Procedure: Ultrasonic ablation

Parathyroidectomy

Active Comparator group

Description:

Patients in parathyroidectomy group will be treated by parathyroid surgery.