Rational Approach to Unilateral Pleural Effusion in Patients Suspected of Malignancy. Efficacy, Pain, Quality of Life, and Economy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Number of diagnostic thoracoscopies (either MT or VATS)
研究概览
简要总结
Recurrent unilateral, non-infectious pleural exudate is suspicious for primary or secondary pleural malignancy. Both conditions are associated with 5-year survival of 10%. Work-up is difficult, as the pleural surface is large and <33% of pleural malignancies shed malignant cells to the pleural fluid. Even so, additional tissue biopsies are needed for establishing mutation status for targeted therapies.
Optimal imaging to guide tissue sampling is pivotal. PET-CT has higher sensitivity than conventional CT for detecting malignant lesions >10mm. However, no randomised trial has investigated differences in diagnostic accuracy, time-to-diagnosis, or economics. Falsely PET-positive lesions in e.g. colon however, lead to more derived tests than do CT alone.
Gold standard for pleural tissue sampling is the surgical (VATS) thoracoscopy, allowing direct visual guiding of tissue sampling from all pleural surfaces. Yet, globally the medical (pleuroscopy) thoracoscopy is more widely used: cheaper, outpatient procedure, but allows only sampling from the parietal pleura. To date, no randomised studies have compared medical and surgical thoracoscopy concerning diagnostic hit rates, adverse events, or economics.
The investigators will perform two randomized studies to investigate whether
- PET/CT is comparable to CT alone
- VATS is comparable to pleuroscopy concerning hit rate, total investigations performed, time-to-diagnosis.
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
- 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
- •Patients with recurrent pleural effusion of unknown origin after a first pleural tap according to BTS guidelines.
- •Indication for thoracoscopy according to BTS guidelines.
- •Patients accept further investigation according to Danish and BTS guidelines.
- •Have received oral and written consent and agreed.
- •At the time of inclusion, above 18 years of age.
排除标准
- •Female patients: pregnancy or breastfeeding.
- •Lack of language comprehension.
- •Legally incompetent patients.
- •Life expectancy less than 3 month.
- •Contraindications to pleural tissue sampling.
结局指标
主要结局
Number of diagnostic thoracoscopies (either MT or VATS)
时间窗: 2 years
次要结局
- Total costs calculated as costs patient-related, procedure-related, and overall(2 years)
- Total procedures before cancer-diagnosis (cancer = yes/no)(2 years)
- Number of patients diagnosed with cancer (cancer = an unequivocal diagnosis of neoplastic disease; no cancer = clinically benign cause, and improved imaging at 6 month control)(2 years)
- Number of derived investigations (i.e. gastroscopy, coloscopy)(2 years)
- Patient satisfaction and patient perceived discomfort(2 years)
研究者
Simon Reuter
MD
Naestved Hospital