Short- and Long-Term Outcomes of Adrenalectomy for Primary Aldosteronism in a Single UK Centre: Rear Mirror View
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 主要终点
- Short- and long-term assessment of clinical improvement in systolic and diastolic blood pressure
研究概览
简要总结
The proposed study is this. Short- and long-term outcomes of adrenalectomy for Primary Aldosteronism (PA) in a single centre. PA is a relatively common problem and considers as the commonest cause of secondary hypertension and can be successfully treated by adrenalectomy.
The investigators aim to gather clinical data routinely collected on participants with primary aldosteronism pre-operatively and post-operatively for a short and long term follow up.
详细描述
Retrospective analysis of data from a prospectively maintained database of participants with PA who underwent surgery between 1st January 1998 and 31st December 2022 at University College London Hospital, a tertiary referral centre for endocrinology and endocrine surgery.
The clinical pathway for screening, diagnosis and stratification for adrenalectomy varied through the 24 years and was based on concurrent recommendations, published evidence, changing local expertise and best practice at the time. Throughout this period diagnosis of PA in our centre was based on the presence of hypertension and hypokalaemia, high aldosterone level, suppressed renin activity and aldosterone and renin ratio (ARR) above 850. Currently a confirmatory test (for example, saline suppression test) recommended if the aldosterone is <550pmol/L but in the upper third of the normal range or the plasma renin is non-suppressed unless the patient presents with spontaneous hypokalaemia, plasma renin below detection levels and aldosterone concentration more than 550 pmol/L.
Stratification for adrenalectomy, once a diagnosis of PA was confirmed, included cross sectional imaging of adrenals with computed tomography (CT) or magnetic resonance imaging (MRI). Adrenal venous sampling (AVS) and/or later 11C Metomidate positron emission tomography-CT (PET-CT) scan was performed if imaging showed bilateral adrenal nodules. Surgery was recommended after discussion in the multidisciplinary team meeting (endocrinologist, endocrine surgeon, biochemists and radiologist).
During the very beginning of the study laparoscopic adrenalectomy was introduced and transperitoneal lateral technique was used to perform laparoscopic adrenalectomy using 3 ports on the left and 4 ports on the right side.
Participants included in the study were characterised preoperatively by their demographics (age, sex and ethnicity) clinical presentation (blood pressure), number of antihypertensive medications and biochemical tests (potassium, aldosterone, renin, ARR ratio).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient underwent adrenalectomy as a management of primary aldosteronism
- •Patient available for short term and long term follow up
排除标准
- •medically treated patients
- •not available for follow up
结局指标
主要结局
Short- and long-term assessment of clinical improvement in systolic and diastolic blood pressure
时间窗: 3 months for short term and 5 years for long term
Short- and long-term clinical changes for the following parameter: -Systolic and diastolic blood pressure measured in mmHg
Short- and long-term assessment of clinical improvement in number of antihypertensive medications in participants
时间窗: 3 months for short term and 5 years for long term
Short- and long-term clinical changes for the following parameter: -Number of antihypertensive medications
次要结局
- Short- and long-term assessment of biochemical improvement in serum Renin level in participants(3 months for short term and 5 years for long term)
- Short- and long-term assessment of biochemical improvement in serum potassium level in participants(3 months for short term and 5 years for long term)
- Short- and long-term assessment of biochemical improvement in serum Aldosterone/Renin ratio (ARR) (pmol/nmol/L) level in participants(3 months for short term and 5 years for long term)
- Short- and long-term assessment of biochemical improvement in serum Aldosterone level in participants(3 months for short term and 5 years for long term)
研究者
Alaa Abdelsalam
Principal investigator and clinical fellow
University College London Hospitals