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Идёт набор NCT06513585

Primary Aldosteronism: Superselective Embolization vs. Laparoscopic Endocrine Curative Therapy

Без фазы С лечением Primary Aldosteronism Suprarenalectomy Super Selective Adrenal Artery Embolization

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: Superselective adrenal artery embolization or adrenalectomy.
Кому может быть актуально
Состояния в реестре: Primary Aldosteronism, Suprarenalectomy, Super Selective Adrenal Artery Embolization. Базовые параметры: 18 лет — 60 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The First Affiliated Hospital of Xinjiang Medical University

Обзор

The aim of this study was to compare the efficacy and safety of adrenalectomy and superselective adrenal artery embolization in a prospective, multicenter, randomized controlled study. To provide a new interventional alternative therapy for primary aldosteronism.

Подробное описание

Primary hyperaldosteronism is caused by excessive aldosterone secretion caused by adrenal cortex disease, which leads to increased sodium and potassium discharge, increased fluid volume and inhibition of renin-angiotensin-aldosterone system. It is one of the common causes of secondary hypertension as clinical symptoms with hypertension, hypokalemia, hyperaldosterone and low renin. It accounts for 5% to 13% of people with hypertension. In addition to the impact of hypertension itself on the body, the endocrine hormone disorder and electrolyte imbalance associated with PA may also become independent risk factors for cardiovascular and cerebrovascular events, and the risk of stroke, atrial fibrillation and myocardial infarction is significantly higher than that of essential hypertension, so early detection and reasonable treatment are crucial. PA can be divided into 6 types according to the etiology, of which the most common is idiopathic aldosteronism (IHA) and aldosteronoma, accounting for 60% and 30% respectively, unilateral adrenal hyperplasia followed, the other subtypes are less common. Previous guidelines have recommended surgery and drug intervention as the main measures for the treatment of PA, while unilateral PA is preferred by surgery and laparoscopic adrenalectomy. However, surgical treatment also has many limitations: First, not all patients with surgical indications have the opportunity to undergo adrenal resection. Surgical treatment is not suitable for patients with difficult laparoscopic operation, such as obesity, serious abdominal adhesion due to previous surgical history, and high-risk surgery, such as cardiovascular and cerebrovascular diseases and emphysema. In addition, adrenal resection may lead to adrenal dysfunction, serious infection, retroperitoneal hematoma and many other adverse reactions. The efficacy and safety of superselective adrenal artery embolization as a new alternative therapy for PA intervention have been proved. The aim of this study was to compare the efficacy of adrenectomy and superselective adrenal artery embolization according to international PASO evaluation criteria, and to conduct a prospective, multicenter, randomized controlled study in Xinjiang to explore the potential of SAAE as a treatment.

Вмешательства

  • Процедура Superselective adrenal artery embolization or adrenalectomy
    Arm A underwent SAAE treatment, and arm B underwent laparoscopic adrenalectomy.

Первичные конечные точки

  • Complete biochemical cure of PA [Срок оценки: 6 months post intervention]
  • Complete clinical cure of PA [Срок оценки: 6 months post intervention]
Вторичные конечные точки (12)
  • Changes in ambulatory blood pressure and baseline blood pressure [Срок оценки: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months]
  • Change of the number of antihypertensive medications [Срок оценки: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months]
  • Adverse events [Срок оценки: Reported throughout the study period. Approximately 2 years]
  • Readmission rate [Срок оценки: Reported throughout the study period. Approximately 2 years]
  • Change of blood electrolytes (K+, Na +) [Срок оценки: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months]
  • Change of plasma aldosterone [Срок оценки: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months]
  • Change of plasma cortisol [Срок оценки: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months]
  • Change of plasma renin measured [Срок оценки: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months]
  • Change of liver enzymes [Срок оценки: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months]
  • Change of kidney function [Срок оценки: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months]
  • Change of fasting blood glucose [Срок оценки: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months]
  • Change of lipids profiles [Срок оценки: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months]

Критерии участия

Критерии включения

  • Age 18-60
  • Diagnosed with primary aldosteronism according to the 2016 Clinical guidelines of the International Endocrine Society
  • Primary aldosteronism diagnosed according to international guidelines Unilateral disease by AVS or PET-CT criteria
  • Patients and their family members signed informed consent and agreed to participate in the study

Критерии исключения

  • A history of severe hypersensitivity to contrast media
  • Severe liver disease complications, such as thrombocytopenia, esophageal varices rupture bleeding, etc
  • Renal insufficiency (serum creatinine > 176mmol/L or estimated glomerular filtration rate < min.1.73m2)
  • Combined with other secondary hypertension, such as pheochromocytoma, hypercortisolism, renal vascular hypertension (such as renal artery stenosis), renin secretory tumor, renal parenchymatous hypertension, drug-induced hypertension (such as long-term use of glucocorticoids, contraceptives, estrogen, herbal medicines containing glycyrrhizin), pregnancy hypertension and other secondary hypertension
  • Combined with genetic diseases: such as false aldosteronism (Liddle syndrome), Bartter syndrome, familial hypokalemia and hypomagnesia (Gitelman syndrome)
  • Stroke, myocardial infarction and stent implantation occurred in the past 3 months
  • Serious other diseases, such as heart dysfunction (grade IV), acute infections, autoimmune diseases, various malignant tumors, etc
  • Participated in other clinical trials within the past 3 months
  • Pregnant, breastfeeding, or planning a pregnancy
  • Identify patients with alcohol allergy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • The First Affiliated Hospital of Xinjiang Medical University — Ürümqi

Идентификаторы

NCT: NCT06513585 · 20240613

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗