Thermal Ablation Versus Parathyroidectomy for Primary Hyperparathyroidism

Chinese PLA General Hospital (301 Hospital)

Status

Not yet enrolling

Conditions

Cure Rate

Complication Rate

Efficacy and Safety

Treatments

Procedure: Thermal ablation

Procedure: Parathyroidectomy

Study type

Observational

Funder types

Other

Identifiers

NCT06708871

S2024-546-01

Details and patient eligibility

About

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.

Enrollment

520 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.