Radiofrequency Ablation Versus Adrenalectomy for Adenoma in Patients With Primary Aldosteronism and Hypertension

Официальное название

Radiofrequency Ablation Versus Adrenalectomy for Adenoma in Patients With Primary Aldosteronism and Hypertension: a Multicentre Prospective Randomized Study

Обзор

Primary aldosteronism (PA) is characterized by hypertension, frequent hypokalaemia, and an inappropriately high aldosterone-to-renin ratio (ARR). Aldosterone-producing adenoma (APA or Conn syndrome) is one of the main causes of primary aldosteronism. Laparoscopic (LA) total-adrenalectomy or adenoma selective is an option to normalize or at least improve blood pressure (BP) control, hypokalaemia, and normalize the ARR. However, the reported result of surgery is around 50% of clinical cure rate with an overall complication rate of 5 to 14% whereas hormonal success reached around 95%. More recently, radiofrequency ablation (RFA) has been used for patients with primary aldosteronism and unilateral adenoma. Investigator Team assume that treatment of unilateral PA by RFA could achieve similar efficacy to treatment by LA, with potentially less adverse events, and could be a more cost-efficient procedure.

Подробное описание

Primary aldosteronism (PA) is characterized by hypertension, frequent hypokalaemia, and an inappropriately high aldosterone-to-renin ratio (ARR). Aldosterone-producing adenoma (APA or Conn syndrome) is one of the main causes of PA.

Medical therapy or adrenalectomy are the 2 options to be considered. Laparoscopic adrenalectomy (LA) has been reported to be cost-effective compared with lifelong oral administration alone in unilateral PA.

Therefore, LA is the gold standard for unilateral PA to normalize or at least improve blood pressure (BP) control, hypokalaemia, and normalize the ARR. However, the reported result of surgery is around 50% of BP control with an overall complication rate of 5 to 14%.

More recently, radiofrequency ablation (RFA) has been used for patients with APA with an hormonal success obtained in 92% of patients treated by umbrella-shaped needle .

RFA for hypertensive patients with APA seems to be an emerging promising alternative to surgery. . Investigator team anticipate that radiofrequency allows a hormonal success of the same order than with adrenalectomy (around 95%), with simpler follow-up than surgery.

The main objective of the study is to test the non-inferiority of radiofrequency ablation compared to adrenalectomy, among hypertensive patients with primary aldosteronism and unilateral adrenal adenoma in order to normalize hormonal endpoints at 3 months of follow-up.

Cost-effectiveness and cost-utility analysis will be conducted to assess the efficiency of radiofrequency in the frame of the project.

Вмешательства

• Процедура RFA -radiofrequency ablation
  Under real-time multidetector CT-guidance, the patients will be put in either prone or lateral decubitus position to choose for the optimal access route for RFA needle electrode. Under multidetector CT guidance, patients would be treated with regard to optimal RFA needle access route with a hydrodissection or aero dissection if necessary. 2 types of generator (Boston Scientific RF 3000, and Ablatech Amica) and of needle electrodes (Leveen-type extendable, Ablatech) will be used according to the
• Процедура Adrenalectomy
  Adrenalectomy may be performed using a laparoscopic or open approach. In either approach, the gland may be approached transabdominally or retroperitoneally. The choice of surgical approach depends on the size and nature of the lesion, the patient's general characteristics and the expertise of the surgeon. Actually, laparoscopic adrenalectomy is considered as the gold standard treatment for the selected patients

Первичные конечные точки

• aldosterone-to-renin ratio (ARR) after 15min in the sitting position [Срок оценки: 3 months]

Вторичные конечные точки (12)

• Clinical success at 3 months [Срок оценки: 3 months]
• Clinical success at 6 months [Срок оценки: 6 months]
• Correction of hypokalaemia without supplementation or potassium sparing diuretic at 1 month of follow-up [Срок оценки: 1 month]
• Correction of hypokalaemia without supplementation or potassium sparing diuretic at 3 months of follow-up [Срок оценки: 3 months]
• Correction of hypokalaemia without supplementation or potassium sparing diuretic at 6 months of follow-up [Срок оценки: 6 months]
• Biochemical success at 3 months of follow-up [Срок оценки: 3 months]
• mean changes in Blood Pressure values assessed by ABPM at 3 months [Срок оценки: 3 months]
• mean changes in Blood Pressure values assessed by ABPM at 6 months [Срок оценки: 6 months]
• normalisation of office BP at 6 months [Срок оценки: 6 months]
• The use of antihypertensive agents at 6 months after RFA and after surgery [Срок оценки: 6 months]
• surface area destroyed by radiofrequency [Срок оценки: 3 months]
• Number of Adverse events [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Patient over 18 years of age
• Hypertension confirmed into the previous 9 months by ABPM 24h SBP/DBP >130 and/or/80 mmHg and/or diurnal SBP/DBP > 135 and/or 85 mmHg and/or nocturnal SBP/DBP >120 and/or 70 mmHg with or without antihypertensive treatment
• Diagnosis of primary aldosteronism confirmed by hormonal assays no more than 1 year before inclusion
• Presence of a unilateral adrenal nodule <4 cm considered suggestive of a Conn's adenoma on an prior adrenal CT or MRI scan, no more than 1 year before inclusion
• Adrenal venous sampling if age > 35 years (and according to investigator decision if age <35 years) to look for a lateralization of secretion: cannulation was successful when adrenal/peripheral venous cortisol gradients>2 and lateralization was assessed by comparison of right and left adrenal venous aldosterone/cortisol ratios with a cut off value>4 ipsilateral to the nod side to define a positive lateralization of secretion (2) no more than 1 year before inclusion
• nodule accessible to RFA according to the judgement of the interventional radiologist performing radiofrequency before randomisation
• nodule accessible to surgery
• patient willing to return for 6-month follow-up
• adult patient able to read the information sheet and give consent to take part in the study
• Patients affiliated to the French Health Insurance

Критерии исключения

• a negative lateralization of secretion on adrenal venous sampling
• presence of bilateral adrenal tumours
• contralateral or bilateral macronodular adrenal hyperplasia
• no documented primary aldosteronism
• Cushing's syndrome or pheochromocytoma
• adrenal tumour > 4 cm
• refusal to perform adrenal catheterisation if age > 35 years
• double anti-platelet aggregation, coagulation disorders or patients treated with anticoagulant treatment that cannot be stopped
• contraindication to anaesthesia
• excessive proximity to sensitive adjacent organs
• patient who has had a heart attack or stroke within the last 6 months
• allergy to iodine
• renal insufficiency defined as a clearance of <30 ml/min
• refusal to undergo radiofrequency ablation or adrenal surgery
• minors and patients under guardianship, curatorship or safeguard of justice
• Inability to speak, read or write French fluently
• patients who refuse follow-up
• pregnant women or women wishing to become pregnant in the short term; breast-feeding
• person taking part or having taken part in other interventional research in the previous 6 months
• any other relevant exclusion criteria as determined by the investigator

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

Франция · 1 центр

• University Hospital of Toulouse — Toulouse

Идентификаторы

NCT: NCT07470580 · RC31/24/0323 · 2024-A02225-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗