Radiofrequency Ablation Versus Adrenalectomy for Adenoma in Patients With Primary Aldosteronism and Hypertension: a Multicentre Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- aldosterone-to-renin ratio (ARR) after 15min in the sitting position
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Patient treated by RFA -radiofrequency ablation
patients with primary aldosteronism would be treated by RFA using needle electrodes
干预措施: RFA -radiofrequency ablation (Procedure)
Patients treated by adrenalectomy
Patients with primary aldosteronism would be treated by adrenalectomy. Actually, laparoscopic adrenalectomy is considered as the gold standard treatment for the selected patients.
干预措施: Adrenalectomy (Procedure)
结局指标
主要结局
aldosterone-to-renin ratio (ARR) after 15min in the sitting position
时间窗: 3 months
aldosterone-to-renin ratio (ARR) after 15 min in the sitting position. Following the recommendations given by Douillard et al (15), normalisation of the ARR will be defined (according to the measurement method) using: * a cut-off value of the ARR of 23 (plasma aldosterone in pg/mL and direct renin in mIU/l) or 64 (plasma aldosterone in pmol/L and direct renin in mIU/l) * a cut-off value of the ARR of 300 (plasma aldosterone in pg/mL and PRA in ng/mL/h), or 830 (plasma aldosterone in pmol/L and PRA in ng/mL/h), or 25 (plasma aldosterone in pg/mL and PRA in pmol/L/min), or 70 (plasma aldosterone in pmol/l and PRA in pmol/L/min). (8,15) * a cut-off value of the ARR of 46 (plasma aldosterone in pmol/l in Liquid chromatography-tandem mass spectrometry (LC-MS/MS) and renin in mU/l) (16)
次要结局
- Clinical success at 3 months(3 months)
- Clinical success at 6 months(6 months)
- Correction of hypokalaemia without supplementation or potassium sparing diuretic at 1 month of follow-up(1 month)
- Correction of hypokalaemia without supplementation or potassium sparing diuretic at 3 months of follow-up(3 months)
- Correction of hypokalaemia without supplementation or potassium sparing diuretic at 6 months of follow-up(6 months)
- Biochemical success at 3 months of follow-up(3 months)
- mean changes in Blood Pressure values assessed by ABPM at 3 months(3 months)
- mean changes in Blood Pressure values assessed by ABPM at 6 months(6 months)
- normalisation of office BP at 6 months(6 months)
- The use of antihypertensive agents at 6 months after RFA and after surgery(6 months)
- surface area destroyed by radiofrequency(3 months)
- Number of Adverse events(6 months)
- length of stay(6 months)
- Health economic criterion(6 months)