Efficacy and Safety of Ultrasonic Ablation to Treat Secondary Hyperparathyroidism in Chronic Kidney Disease Patients
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|ClinicalTrials.gov Identifier: NCT01640184|
Recruitment Status : Completed
First Posted : July 13, 2012
Results First Posted : November 20, 2015
Last Update Posted : October 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hyperparathyroidism Disorders of Parathyroid Gland||Procedure: Parathyroidectomy Drug: Active vitamin D Procedure: Ultrasonic ablation||Not Applicable|
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,.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||79 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of the Efficacy and Safety on the Ultrasonic Ablation Treatment for Secondary Hyperthyroidism in Chronic Kidney Disease Patients.|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Active Comparator: 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.
Drug: Active vitamin D
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.
Other Name: Oral medicine
Experimental: Ultrasonic ablation
Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.
Procedure: Ultrasonic ablation
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.
Other Name: Ultrasonic intervention
Active Comparator: Parathyroidectomy
Patients in parathyroidectomy group will be treated by parathyroid surgery.
sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
Other Name: Parathyroid surgery
- Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to Kidney Development Improvement Global Outcome (KDIGO) Guidelines. [ Time Frame: 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.
- Incidence of Injury on the Recurrent Laryngeal Nerve (RLN). [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01640184
|Beijing Chao-Yang Hospital|
|Beijing, Beijing, China, 100020|
|Beijing Friendship Hospital|
|Beijing, Beijing, China, 100050|
|Principal Investigator:||Linxue Qian, Doctor||Beijing Friendship Hospital|
|Study Director:||Dongliang Zhang, Doctor||Beijing Friendship Hospital|
|Study Chair:||Wenhu Liu, Doctor||Beijing Friendship Hospital|