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Secondary hyperparathyroidism (SHPT), which is frequently associated with chronic kidney disease, leads to problems such as bone pain, fractures, and cardiovascular issues, thereby affecting patients' quality of life. This clinical trial is designed to compare the efficacy of thermal ablation and surgical treatment for SHPT. Parameters including parathyroid hormone levels, serum calcium and phosphorus levels, SHPT-related symptoms (for example, bone pain, muscle weakness), and complication occurrence will be monitored. The advantages involve enabling better treatment decisions for patients, enhancing patients' quality of life, and alleviating the burden on families, in addition to augmenting the clinical knowledge of healthcare providers. However, both treatments carry risks. Thermal ablation may have problems like incomplete ablation, local tissue damage, and blood parameter changes. Surgical risks comprise bleeding, infection, adjacent tissue damage (such as the recurrent laryngeal nerve), and hypoparathyroidism. The investigators will strive to minimize these risks. This trial is of great significance for SHPT treatment, and the investigators welcome participants to contribute to the advancement of medical science in this area.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therma ablation |
| ||
| Parathyroidectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermal ablation | Procedure | Thermal ablation is a treatment for secondary hyperparathyroidism. There are radiofrequency ablation (RFA) and microwave ablation (MWA). For RFA, an electrode needle is inserted into the parathyroid under imaging guidance. High - frequency current heats the tissue to cause necrosis. MWA uses electromagnetic waves to generate heat by friction. Before ablation, imaging and lab tests are done for evaluation. During the process, precise positioning and real - time monitoring are key. After that, patients are observed for bleeding, swelling and other symptoms, and tests are repeated to assess the effect. |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement rate of target PTH value | 6 months after surgery or ablation | |
| Symptom remission rate | The symptom remission rate refers to the proportion of the number of patients whose symptoms have been alleviated to the total number of patients treated in the treatment of primary hyperparathyroidism, either by surgery or ablation. | 1 year after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| complication rate | The incidence rate of complications refers to the proportion of patients who experience complications after a surgical procedure within a certain period. | within 30 days after surgery or ablation |
| Normalization Probability of Serum Calcium and Phosphorus after Ablation or Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmetology Scoring（Scar Cosmesis Assessment and Rating Scale） | The Scar Cosmesis Assessment and Rating Scale (SCAR) will be utilized to evaluate the cosmetic outcome following surgical or ablation treatment for primary hyperparathyroidism. The observer part of the SCAR assesses six aspects: scar spread, erythema, pigmentation abnormality, surgical marks or suture tracks, hypertrophy/atrophy, and overall impression. The patient part includes two simple questions about patient satisfaction with the scar and the degree of itching. The scale has a minimum value of 0, representing the least severe scar with the best cosmetic appearance, and a maximum value of 15, signifying the most severe scar with the poorest cosmetic result. Higher scores on this scale indicate a worse cosmetic outcome. |
Inclusion Criteria:
Exclusion Criteria:
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Patients must have a confirmed diagnosis of secondary hyperparathyroidism based on clinical symptoms (such as bone pain, fractures, pruritus), biochemical parameters (elevated parathyroid hormone, abnormal calcium, phosphorus, and alkaline phosphatase levels), and relevant medical history (especially those with underlying chronic kidney disease or other relevant disorders). All patients must provide written informed consent after a detailed discussion of the study purpose, procedures, potential risks, and benefits of both treatment options by the research team.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Liu | Contact | +8616601565730 | yang2818025107@163.com |
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| ID | Term |
|---|---|
| D020728 | Transurethral Resection of Prostate |
| D016105 | Parathyroidectomy |
| ID | Term |
|---|---|
| D011468 | Prostatectomy |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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| parathyroidectomy | Procedure | Parathyroidectomy for secondary hyperparathyroidism is a common approach. The surgeon first makes an incision in the neck area under general or local anesthesia. Then, the enlarged parathyroid glands are carefully identified and dissected. Precise surgical skills are required to avoid damaging nearby structures such as the recurrent laryngeal nerve and blood vessels. After the removal of the abnormal parathyroid tissue, the wound is closed. |
|
The probability of normal serum calcium and serum phosphorus levels after ablation or surgical treatment for primary hyperparathyroidism is defined as the proportion of patients in whom the levels of blood calcium and blood phosphorus return to the normal physiological range among all the patients who have received either ablation or surgical procedures for this condition. |
| 6 months post-treatment |
| Bone mineral density change | Bone mineral density change after treatment is defined as the alteration in bone density measured by DEXA in patients with primary hyperparathyroidism after surgery or ablation. | 2 years |
| Assessment of Changes in Bone Metabolism Markers Including BALP, PINP, and ALP for Treating Primary Hyperparathyroidism by Surgery and Ablation | Changes in Bone Metabolism Markers will be evaluated by measuring specific biochemical parameters. These include serum levels of bone-specific alkaline phosphatase (BALP), which is a biomarker reflecting osteoblast activity. Another important marker is N-terminal propeptide of type I collagen (PINP), which is involved in collagen synthesis and provides insights into bone formation. ALP is a well-known enzyme related to bone metabolism and its elevation can be indicative of increased osteoblastic activity. The levels of these markers will be determined using enzyme-linked immunosorbent assay (ELISA) kits, which are highly sensitive and specific laboratory assays. | 1 year |
| All - cause mortality rate | 2 years |
| at 3 months, 6 months, and 1 year post-procedure |
| Readmission Rate within 30 Days | within 30 days after surgery or ablation |
| Evaluation of the Learning Curve for Surgical and Ablation Procedures in Treating Primary Hyperparathyroidism: Incorporating Key Performance Indicators and Patient Cure Outcomes | The learning curve for surgical or ablation procedures will be evaluated by tracking and analyzing key performance indicators, with patient cure outcomes also taken into account. These indicators encompass the time taken from the start of the procedure until its completion (operation time). Additionally, the rate of occurrence of immediate and short-term post-operative complications (like bleeding, nerve injury) is considered. Patient cure status, such as complete remission of related symptoms, normalization of relevant physiological indicators, and long-term disease-free survival, will be meticulously assessed to comprehensively evaluate the effectiveness and learning the effectiveness and learning curve of these procedures. | through study completion, an average of 2 year |
| D013514 | Surgical Procedures, Operative |
| D013507 | Endocrine Surgical Procedures |