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Набор скоро начнётся NCT06709586

Thermal Ablation Versus Parathyroidectomy for Secondary Hyperparathyroidism

— Наблюдательное Achievement Rate Efficacy and Safety PTH Calcium

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Thermal ablation, parathyroidectomy.
Кому может быть актуально
Состояния в реестре: Achievement Rate, Efficacy and Safety, PTH, Calcium. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Thermal Ablation Versus Parathyroidectomy for Secondary Hyperparathyroidism: a Multicenter Study

Обзор

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.

Вмешательства

  • Процедура Thermal ablation
    Thermal ablation is a treatment for secondary hyperparathyroidism. There are radiofrequency ablation (RFA) and microwave ablation (MWA). For RFA, an electrode needle is inserted into the parathyroid under imaging guidance. High - frequency current heats the tissue to cause necrosis. MWA uses electromagnetic waves to generate heat by friction. Before ablation, imaging and lab tests are done for evaluation. During the process, precise positioning and real - time monitoring are key. After that, pat
  • Процедура parathyroidectomy
    Parathyroidectomy for secondary hyperparathyroidism is a common approach. The surgeon first makes an incision in the neck area under general or local anesthesia. Then, the enlarged parathyroid glands are carefully identified and dissected. Precise surgical skills are required to avoid damaging nearby structures such as the recurrent laryngeal nerve and blood vessels. After the removal of the abnormal parathyroid tissue, the wound is closed.

Первичные конечные точки

  • Achievement rate of target PTH value [Срок оценки: 6 months after surgery or ablation]
  • Symptom remission rate [Срок оценки: 1 year after treatment]
Вторичные конечные точки (5)
  • complication rate [Срок оценки: within 30 days after surgery or ablation]
  • 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]
  • Assessment of Changes in Bone Metabolism Markers Including BALP, PINP, and ALP for Treating Primary Hyperparathyroidism by Surgery and Ablation [Срок оценки: 1 year]
  • All - cause mortality rate [Срок оценки: 2 years]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • severe bleeding tendency or coagulation disorders, severe cardiopulmonary abnormalities, and abnormal vital signs such as severe hypertension, arrhythmias, and anemia

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: NCT06709586 · S2024-11-10

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗