Antecubital Versus Femoral Approach for Adrenal Venous Sampling: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- The success rate of bilateral adrenal venous sampling
研究概览
简要总结
Subtype diagnosis is crucial for the treatment of primary aldosteronism (PA), which conducts the appropriate treatment strategy. Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. At present, almost all medical centers use the femoral vein approach for AVS, and most studies report that the success rate is 30%-80%. Our research team is the first in the world to conduct AVS via an antecubital approach. The aim of this study is to compare the success rate and safety of AVS via antecubital and femoral approach.
详细描述
Primary aldosteronism (PA) is one of the most common causes of secondary hypertension, and its most common subtypes are aldosterone-producing adenoma and idiopathic hyperaldosteronism, which account for 95% to 98% of PA. Subtype diagnosis is crucial for the treatment of primary aldosteronism, which conducts the appropriate treatment strategy. Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. At present, almost all medical centers use the femoral vein approach for AVS, and most studies report that the success rate is 30%-80%.How to improve the success rate of AVS has been a hot topic in the field of primary aldosteronism. Our research team is the first in the world to conduct AVS via an antecubital approach. The previous study found that the success rate of AVS via this approach can reach to 88.0%, with a low incidence of complications. In this study, patients with primary aldosteronism who meet the indications of AVS will be randomly assigned to antecubital approach group and femoral approach group. Clinical, laboratory and examination data will be recorded and the success rate and safety of AVS via antecubital and femoral approach will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 18 to 60 with no limits in sex;
- •Patients with confirmed primary aldosteronism;
- •Patients or their legal representatives sign written informed consent approved by the ethics committee
排除标准
- •Severe comorbidity, including stroke, myocardial infarction, heart failure, severe valvular heart disease, liver cirrhosis, and metastatic tumor within the previous 3 months；
- •An estimated glomerular filtration rate <45 ml/min/1.73 m2, or serum creatinine >176 μmol/L；
- •Patients who refuse adrenalectomy;
- •suspected of having an adrenocortical carcinoma;
- •allergy to contrast agent;
- •pregnant, nursing, or planning to become pregnant
结局指标
主要结局
The success rate of bilateral adrenal venous sampling
时间窗: At AVS procedure
Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava \>2 without ACTH simulation)
次要结局
- the incidence of complications(1 week after AVS procedure)
- The success rate of left adrenal venous sampling(At AVS procedure)
- Selection of intraoperative catheter(At AVS procedure)
- The contrast agent dosage(At AVS procedure)
- The success rate of right adrenal venous sampling(At AVS procedure)
- Time of fluoroscopy(At AVS procedure)
- the cost of the procedure(At AVS procedure)
- Time of the procedure(At AVS procedure)
研究者
Hui DONG
professor
Chinese Academy of Medical Sciences, Fuwai Hospital