Pathological Type，Gene Mutation and Clinical Characteristics of Unilateral Primary Aldosteronism，A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Define the aldosterone-producing adenoma and aldosterone-producing nodule(classical)proportions
研究概览
简要总结
- Aim to investigate the pathological feature of UPA in Asians
- To clarify the relationship between pathology, clinical phenotype, genetic mutation and surgical outcome of UPA in Asians.
- To explore a new pathological type of unilateral primary aldosterone
详细描述
The multi-center expert team led by Tracy Ann Williams formulated the International Consensus on the Pathological Diagnosis of Unilateral aldehyde disease, which standardized the pathological classification of unilateral PA. The previous retrospective study of the research group found that the pathologic types of unilateral primary aldosteronoma were mainly classical, and aldosteronoma was the most common. There was no significant difference in clinical features and postoperative biochemical remission rate between patients with classic and non-classic, but the clinical prognosis of the latter group was worse than that of the classical group. However, the study was retrospective and there may be inclusion bias. The pathologic distribution and clinical features of unilateral aldehyde disease are not completely clear and need to be discussed in prospective studies.Therefore，this study aims to determine the composition ratio of different pathological types in patients with unilateral procaldosis enrolled in our center. Gene mutation of different pathological types, the relationship between pathology and clinical phenotype, gene mutation, etc.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No gender limitation;
- •Age 18-80 years old;
- •The patient was diagnosed with UPA and underwent total adrenal resection.
排除标准
- •Bilateral disease
- •Partial of no biochemical response in follow-up
- •partial adrenalectomy
结局指标
主要结局
Define the aldosterone-producing adenoma and aldosterone-producing nodule(classical)proportions
时间窗: 2 weeks after surgery
Adrenal operative specimens were diagnosed as aldosterone-producing adenoma、aldosterone-producing nodule、aldosterone-producing micronodules、aldosterone-producing diffusehyperplasia according to HE and CYP11B2 staining
The proportion with genetic mutations
时间窗: 2 weeks after surgery
The adrenal tumor was diagnosed by gene sequencing as KCNJ5 mutation, ATP1A1 mutation, ATP2B3 mutation or CACNA1D mutation,etc.
Analyze the Aldosterone level and renin level Characteristics
时间窗: 2 weeks after surgery
Aldosterone level（pg/ml）, renin level（uIU/ml）, blood potassium（mmol/L） and blood pressure are the main clinical indicators of primary aldosteronism(Aldosterone level divided by renin level to obtain ARR, ARR greater than 20 consider whether aldosterone autonomic secretion),different pathological types of aldosteronomas were measured to analyze whether there were differences in clinical characteristics of adrenal tumors of different pathological types
次要结局
- Define the ldosterone-producing micronodules and aldosterone-producing diffusehyperplasia(Nonclassical)proportions(2 weeks after surgery)
- Analyze the blood potassium and blood pressure Characteristics(2 weeks after surgery)
研究者
Qifu Li
Primary investigator
Chongqing Medical University