Impact of Pleural Manometry on the Assessment and Treatment of Malignant Pleural Effusion: A Pilot Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Successful pleurodesis based on radiographic assessment
研究概览
简要总结
The goal of this clinical trial is to find out if performing a pleural fluid drainage (thoracentesis) together with the measurement of pressure inside the chest (pleural manometry) during the same procedure can help doctors choose the best treatment for each patient with malignant pleural effusion.The main questions it aims to answer are:
- Is the use of pleural manometry associated with a higher success rate in managing malignant pleural effusion through pleurodesis?
- Can the use of pleural manometry help guide optimal therapeutic decision-making in malignant pleural effusion?
Researchers will compare the success of the chosen treatment in patients who undergo pleural manometry to those who do not, to see if pleural manometry helps improve treatment outcomes for malignant pleural effusion.
Participants will:
- Receive treatment according to the hospital's standard clinical practice for managing malignant pleural effusion.
- If assigned to the manometry group, they will undergo pleural manometry during their first thoracentesis.
- If the manometry results suggest that the lung can fully expand, they will be referred for pleurodesis-just as patients in the non-manometry group are.
- If the manometry results suggest that the lung cannot fully expand, pleurodesis will not be recommended due to the high risk of failure. Instead, placement of a tunneled pleural catheter will be advised to help control symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Histologically confirmed cancer and symptomatic patient with at least one of the following:
- •Malignant pleural effusion confirmed by cytology.
- •Recurrent exudative pleural effusion without an alternative diagnosis in the context of confirmed extrapleural cancer.
- •Pleural effusion associated with hypermetabolic pleural thickening suggestive of malignant pleural effusion.
排除标准
- •Radiological evidence of non-expandable lung
- •Life expectancy <1 month (LENT score: high risk)
- •Previous ipsilateral lobectomy or pneumonectomy
- •Previous ipsilateral chemotherapy or radiotherapy
- •Presence of infected pleural effusion
- •Patient preference for tunneled pleural catheter placement
- •Pregnancy
- •Thrombocytopenia or coagulopathy
- •Contraindication to general anesthesia or sedation
结局指标
主要结局
Successful pleurodesis based on radiographic assessment
时间窗: 30 days after hospital discharge
Number of participants with successful pleurodesis, defined as absence of recurrent pleural effusion or presence of minimal or loculated effusion that does not require additional therapeutic procedures to relieve symptoms. Assessment will be performed using chest X-ray interpreted by the thoracic surgeon at the follow-up visit.
次要结局
未报告次要终点