Thermal Ablation Versus Parathyroidectomy for Primary Hyperparathyroidism

N/ANot Yet RecruitingNCT06708871

Chinese PLA General Hospital520 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

520

Conditions

Cure Rate Complication Rate Efficacy and Safety

Interventions

Thermal ablation is a minimally invasive procedure used to treat primary hyperparathyroidism, a condition where one or more of the parathyroid glands produce excessive amounts of parathyroid hormone (PTH). The treatment involves using heat to destroy the overactive parathyroid tissue. This can be done through various methods such as radiofrequency ablation (RFA) and microwave ablation(MWA).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

cure rate

The cure rate is the probability that postoperative levels of parathyroid hormone (PTH) and blood calcium reach the target values.

Time frame: 6 months after surgery or ablation

Secondary Outcomes

complication rate

The incidence rate of complications refers to the proportion of patients who experience complications after a surgical procedure within a certain period.

Time frame: within 30 days 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.

Time frame: 1 year after treatment initiation

Normalization Probability of Serum Calcium and Phosphorus after Ablation or Surgery

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.

Time frame: 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.

Time frame: 2 years