Clinical trial NCT01640184: Efficacy and Safety of Ultrasonic Ablation to Treat Secondary Hyperparathyroidism in Chronic Kidney Disease Patients
Official title: Study of the Efficacy and Safety on the Ultrasonic Ablation Treatment for Secondary Hyperthyroidism in Chronic Kidney Disease Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperparathyroidism
Disorders of Parathyroid Gland
Keywords: hyperparathyroidism
vitamin D
ultrasonic ablation
surgery
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Science & Technology Commission
First posted: 2012-07-13
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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,.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to Kidney Development Improvement Global Outcome (KDIGO) Guidelines.
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of Injury on the Recurrent Laryngeal Nerve (RLN).
timeFrame: 12 months
measure: Changes of the Blood Levels on Calcium During 12 Months.
timeFrame: Baseline and 12 months
measure: Changes of Blood Levels on Phosphorus During 12 Months.
timeFrame: Baseline and 12 months
measure: Changes of Blood Levels on iPTH During 12 Months.
timeFrame: Baseline and 12 months
measure: Changes of Blood Levels on Bone Specific Alkaline Phosphatase.
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Linxue Qian, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Friendship Hospital
name: Dongliang Zhang, Doctor
role: STUDY_DIRECTOR
affiliation: Beijing Friendship Hospital
name: Wenhu Liu, Doctor
role: STUDY_CHAIR
References: