Clinical trial NCT06709586: Thermal Ablation Versus Parathyroidectomy for Secondary Hyperparathyroidism
Official title: Thermal Ablation Versus Parathyroidectomy for Secondary Hyperparathyroidism: a Multicenter Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Achievement Rate
Efficacy and Safety
PTH
Calcium
Clinical Symptoms
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 612
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Achievement rate of target PTH value
timeFrame: 6 months after surgery or ablation
measure: Symptom remission rate
timeFrame: 1 year after treatment
Secondary outcomes:
measure: complication rate
timeFrame: within 30 days after surgery or ablation
measure: Normalization Probability of Serum Calcium and Phosphorus after Ablation or Surgery
timeFrame: 6 months post-treatment
measure: Bone mineral density change
timeFrame: 2 years
measure: Assessment of Changes in Bone Metabolism Markers Including BALP, PINP, and ALP for Treating Primary Hyperparathyroidism by Surgery and Ablation
timeFrame: 1 year
measure: All - cause mortality rate
timeFrame: 2 years
Other outcomes:
measure: Cosmetology Scoring（Scar Cosmesis Assessment and Rating Scale）
timeFrame: at 3 months, 6 months, and 1 year post-procedure
measure: Readmission Rate within 30 Days
timeFrame: within 30 days after surgery or ablation
measure: Evaluation of the Learning Curve for Surgical and Ablation Procedures in Treating Primary Hyperparathyroidism: Incorporating Key Performance Indicators and Patient Cure Outcomes
timeFrame: through study completion, an average of 2 year
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Study officials:
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