Structured Evaluation of adRENal Tumors Discovered Incidentally - Prospectively Investigating the Testing Yield
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 807
- 试验地点
- 1
- 主要终点
- Cost-effectiveness
研究概览
简要总结
Standard diagnostic work-up for adrenal incidentalomas (AI) consists of periodical biochemical analysis and CT-scanning in case the initial work-up does not demonstrate the presence of hormonal hypersecretion or adrenocortical carcinoma (ACC), respectively. The overall aim of this study is to improve the cost-effectiveness of the diagnostic strategy for AI. Cost-effectiveness of urine steroid profiling (USP) will be compared to the standard diagnostic strategy of repeated CT-imaging.
详细描述
Rationale: Standard diagnostic work-up for adrenal incidentalomas (AI) consists of periodical biochemical analysis and CT-scanning in case the initial work-up does not demonstrate the presence of hormonal hypersecretion or adrenocortical carcinoma (ACC),respectively. With respect to the diagnosis of ACC, the health benefits of this strategy are controversial for the following reasons: a. critical appraisal of literature has revealed a much lower ACC frequency of 1.9% than previously presumed; b. CT sensitivity and specificity are suboptimal; c. risk of unnecessary adrenalectomies; d. exposure to ionising radiation; e. risk of CT contrast reactions (nephropathy, allergic reaction); f. health care related and economical costs. The hypothesis to be tested is that incorporation of a single baseline urinary steroid profiling (USP) into the management algorithm of AI is more cost-effective than a strategy solely based on repeat CT-scanning.
Objective
SERENDIPITY aims to improve the cost-effectiveness of the diagnostic strategy for AI by the application of a single baseline USP. In addition, we aim to examine the psychological impact for patients with AI being currently subjected to repeated laboratory tests and CT-scanning during several years.
Study design: This is a prospective observational multicenter study. Study population: Patients are eligible if they meet the following inclusion criteria: adrenal mass > 1 cm in diameter incidentally discovered during CT or MRI-scanning, performed for reasons other than an evaluation for adrenal disease and age 18 years or older. The exclusion criteria are: extra-adrenal malignancy (i.e. active or past medical history of malignancy, except for basal cell carcinoma), radiologic diagnosis of simple cyst or bilateral adrenal masses, allergy to radiocontrast, renal insufficiency (i.e. eGFR < 30 ml/min/1.73m2), pregnancy or inability to understand written Dutch.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •discrete adrenal mass > 1 cm in diameter incidentally discovered during CT/MRI-scanning, performed for reasons other than an evaluation for adrenal disease
- •detection CT/MRI-scan performed ≤ 4 months ago
- •age 18 years or older.
排除标准
- •extra-adrenal malignancy (i.e. active or past medical history of malignancy, except for basal cell carcinoma)
- •radiologic diagnosis of simple cyst or bilateral adrenal masses
- •allergy to radiocontrast
- •renal insufficiency (i.e. eGFR < 30 ml/min/1.73m2)
- •pregnancy
- •adrenal incidentaloma visible on previous (i.e. > 4 months ago) CT/MRI-scan
- •inability to understand written Dutch.
结局指标
主要结局
Cost-effectiveness
时间窗: 2 years
difference in cost-effectiveness of the current management strategy based on repeat CT-scanning to detect ACC among patients with an AI compared with a strategy using a single baseline USP
次要结局
- frequency of ACC among patients with AI at baseline or during follow-up(2 years)
- distribution of pathologic diagnosis in surgically removed adrenal glands(2 years)
- determination of the percentage of AI that meets the criteria of a malignant CT- phenotype at baseline or during follow-up(2 years)
- QoL in patients with an AI at baseline and during follow-up(2 years)
- frequency distribution between hormonal hypersecreting and non-functional AI(2 years)
- conversion rate from non-functioning AI towards a hypersecreting AI during follow-up(2 years)
- costs of diagnostic procedures and surgical interventions(2 years)