Achievement Rate, Calcium, Clinical Symptoms, Efficacy and Safety, PTH
Conditions
Brief summary
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.
Interventions
PROCEDUREThermal ablation
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.
PROCEDUREparathyroidectomy
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.
Sponsors
Chinese PLA General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* persistent serum iPTH (intact parathyroid hormone) levels \> 800 pg/mL； * resistance to calcimimetics, vitamin D, and its analogs, with ineffective conventional internal medicine comprehensive treatment； * severe bone pain, osteoporosis, muscle pain, ectopic soft tissue calcification, or other factors affecting quality of life； * imaging examinations indicating the presence of at least one enlarged parathyroid gland
Exclusion criteria
* severe bleeding tendency or coagulation disorders, severe cardiopulmonary abnormalities, and abnormal vital signs such as severe hypertension, arrhythmias, and anemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom remission rate | 1 year after treatment | 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. |
| Achievement rate of target PTH value | 6 months after surgery or ablation | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Normalization Probability of Serum Calcium and Phosphorus after Ablation or Surgery | 6 months post-treatment | 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. |
| Bone mineral density change | 2 years | 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. |
| complication rate | within 30 days after surgery or ablation | The incidence rate of complications refers to the proportion of patients who experience complications after a surgical procedure within a certain period. |
| Assessment of Changes in Bone Metabolism Markers Including BALP, PINP, and ALP for Treating Primary Hyperparathyroidism by Surgery and Ablation | 1 year | 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. |
| All - cause mortality rate | 2 years | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Readmission Rate within 30 Days | within 30 days after surgery or ablation | — |
| Cosmetology Scoring（Scar Cosmesis Assessment and Rating Scale） | at 3 months, 6 months, and 1 year post-procedure | 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. |
| Evaluation of the Learning Curve for Surgical and Ablation Procedures in Treating Primary Hyperparathyroidism: Incorporating Key Performance Indicators and Patient Cure Outcomes | through study completion, an average of 2 year | 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. |
Contacts
Primary ContactYang Liu
Outcome results
None listed