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

Study Overview
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Brief Summary
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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
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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,.

Official Title
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Study of the Efficacy and Safety on the Ultrasonic Ablation Treatment for Secondary Hyperthyroidism in Chronic Kidney Disease Patients.

Conditions
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Hyperparathyroidism, Disorders of Parathyroid Gland

Intervention / Treatment
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* Procedure: Parathyroidectomy
* Drug: Active vitamin D
* Procedure: Ultrasonic ablation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active vitamin D<br>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. | Drug: Active vitamin D<br>* 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.<br>* Other names: Oral medicine;|
| Experimental: Ultrasonic ablation<br>Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. | Procedure: Ultrasonic ablation<br>* 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.<br>* Other names: Ultrasonic intervention;|
| Active Comparator: Parathyroidectomy<br>Patients in parathyroidectomy group will be treated by parathyroid surgery. | Procedure: Parathyroidectomy<br>* sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.<br>* Other names: Parathyroid surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Injury on the Recurrent Laryngeal Nerve (RLN). | Comparison of the incidence of RLN injury between ultrasonic ablation group and parathyroidectomy group. | 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. | 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. | 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. | 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. | Baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperparathyroidism, vitamin D, ultrasonic ablation, surgery