Thermal Ablation Versus Parathyroidectomy for Primary Hyperparathyroidism

Официальное название

Thermal Ablation Versus Parathyroidectomy for Primary Hyperparathyroidism: a Multicenter Study

Обзор

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.

Вмешательства

• Процедура Thermal ablation
  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).
• Процедура Parathyroidectomy
  Parathyroidectomy is a surgical procedure to remove one or more of the parathyroid glands in cases of hyperparathyroidism.

Первичные конечные точки

• cure rate [Срок оценки: 6 months after surgery or ablation]

Вторичные конечные точки (4)

• complication rate [Срок оценки: within 30 days after surgery or ablation]
• symptom remission rate [Срок оценки: 1 year after treatment initiation]
• Normalization Probability of Serum Calcium and Phosphorus after Ablation or Surgery [Срок оценки: 6 months post-treatment]
• Bone mineral density change [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06708871 · S2024-546-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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