Clinical trial NCT06708871: Thermal Ablation Versus Parathyroidectomy for Primary Hyperparathyroidism
Official title: Thermal Ablation Versus Parathyroidectomy for Primary Hyperparathyroidism: a Multicenter Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cure Rate
Complication Rate
Efficacy and Safety
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 520
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 PHPT based on biochemical and clinical evaluations. Biochemical evidence includes elevated parathyroid hormone (PTH) levels in conjunction with hypercalcemia (serum calcium above the normal reference range). Clinical manifestations may include, but are not limited to, bone pain, osteoporosis, kidney stones, or other symptoms related to the disease.All patients must provide written informed consent after a detailed discussion of the study procedures, potential risks, and benefits of both thermal ablation and surgical treatment options. This ensures that patients are fully aware of what participation in the study entails and have voluntarily agreed to take part.

Brief summary: This study is a prospective, multicenter study designed to compare the efficacy and safety of surgical treatment versus ablation therapy (including radiofrequency ablation and microwave ablation) for patients with primary hyperparathyroidism (PHPT). The study will assess the impact of both treatment modalities on serum parathyroid hormone (iPTH) and calcium levels, clinical symptom improvement, bone mineral density enhancement, reduction in the incidence of urinary system stones, and postoperative complication rates. While surgical treatment has been the standard of care for PHPT, offering definitive cure, it carries inherent surgical risks and complications. Ablation therapy, as a minimally invasive approach, presents a novel alternative with reduced trauma and fewer complications. The outcomes of this study will inform clinical decision-making and potentially optimize treatment strategies for patients with PHPT.


Eligibility criteria: Inclusion Criteria:

* Symptomatic patients with primary hyperparathyroidism, such as those with symptoms in any system including the kidneys, bones, gastrointestinal tract, psychoneurological system, or those with atypical symptoms such as muscle weakness, dysfunction, and sleep disorders.
* Asymptomatic PHPT patients with any of the following conditions:

  ① Serum calcium is higher than the upper limit of the normal value by 1 mg/dL (0.25 mmol/L);

  ② There is objective evidence of renal involvement, including asymptomatic kidney stones, nephrocalcinosis, hypercalciuria (24 - hour urinary calcium level \> 400 mg/dL) on renal imaging, or impaired renal function (glomerular filtration rate \< 60 mL/min);

  ③ There is evidence of osteoporosis (bone mineral density decreased by 2.5 standard deviations at any site) and/or radiographic evidence of fragility fractures.

  ④ Age \< 50 years

  ⑤ The patient cannot accept routine follow - up observation.
* Imaging examination shows that at least one parathyroid gland is enlarged.

Exclusion Criteria:

* diagnosis of secondary or tertiary HPT
* severe coagulation disorder
* severe cardiopulmonary insufficiency

Primary outcomes:
measure: cure rate
timeFrame: 6 months after surgery or ablation
Secondary outcomes:
measure: complication rate
timeFrame: within 30 days after surgery or ablation
measure: symptom remission rate
timeFrame: 1 year after treatment initiation
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
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: All - cause mortality rate
timeFrame: 2 years
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
Locations:
Study officials:
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