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| ID | Type | Description | Link |
|---|---|---|---|
| Z121107001012138 | Other Grant/Funding Number | Beijing Municipal Science and Technology Commission | |
| 2001-2002-02 | Other Grant/Funding Number | The capital health research and development of special |
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| Name | Class |
|---|---|
| Beijing Municipal Science & Technology Commission | OTHER |
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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.
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,.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active vitamin D | Active Comparator | 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. |
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| Ultrasonic ablation | Experimental | Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. |
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| Parathyroidectomy | Active Comparator | Patients in parathyroidectomy group will be treated by parathyroid surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parathyroidectomy | Procedure | sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linxue Qian, Doctor | Beijing Friendship Hospital | Principal Investigator |
| Dongliang Zhang, Doctor | Beijing Friendship Hospital | Study Director |
| Wenhu Liu, Doctor | Beijing Friendship Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao-Yang Hospital | Beijing | Beijing Municipality | 100020 | China | ||
| Beijing Friendship Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Vitamin D | Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Active vitamin D | Drug | 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. |
|
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| Ultrasonic ablation | Procedure | 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. |
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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 |
| Beijing |
| Beijing Municipality |
| 100050 |
| China |
| FG001 | Ultrasonic Ablation | Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. 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. |
| FG002 | Parathyroidectomy | Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Vitamin D | Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines. 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. |
| BG001 | Ultrasonic Ablation | Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. 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. |
| BG002 | Parathyroidectomy | Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Ca-baseline | Blood level of Calcium on baseline. | Mean | Standard Deviation | mmol/L |
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| P-baseline | Blood level of phosphorus on baseline. | Mean | Standard Deviation | mmol/L |
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| iPTH-baseline | Blood level of intact parathyroid hormone on baseline. | Mean | Standard Deviation | ng/ml |
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| BALP-baseline | Blood level of Bone-alkaline phosphatase (BALP) on baseline. | Mean | Standard Deviation | microgram/L |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Number of participants analyzed is the number of patients completed study. | Posted | Number | percentage of participants | 12 months |
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| Secondary | Incidence of Injury on the Recurrent Laryngeal Nerve (RLN). | Comparison of the incidence of RLN injury between ultrasonic ablation group and parathyroidectomy group. | Posted | Number | participants | 12 months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | mmol/L | Baseline and 12 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | mmol/L | Baseline and 12 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | ng/ml | Baseline and 12 months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | microgram/L | Baseline and 12 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Vitamin D | Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines. 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. | 1 | 34 | 0 | 34 | ||
| EG001 | Ultrasonic Ablation | Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. 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. | 0 | 23 | 5 | 23 | ||
| EG002 | Parathyroidectomy | Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery. | 0 | 22 | 15 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment | The reason of death was unclear. The patient had been dead when family found. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypocalcemia | Injury, poisoning and procedural complications | Systematic Assessment | Blood ionized calcium level decreased caused by surgery. |
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| Hoarse | Injury, poisoning and procedural complications | Systematic Assessment | Recurrent laryngeal nerve injury caused by surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Zhang Dongliang | Peking University International Hospital | +86-10-69006561 | zhangdongliang@pkuih.edu.cn |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D016105 | Parathyroidectomy |
| D019242 | Oral Medicine |
| ID | Term |
|---|---|
| D013507 | Endocrine Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003813 | Dentistry |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG002 | Parathyroidectomy | Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery. |
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| OG002 | Parathyroidectomy | Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery. |
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| OG002 |
| Parathyroidectomy |
Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery. |
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| OG002 | Parathyroidectomy | Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery. |
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