ACTRN12618001013257进行中（未招募）未知
The Australasian Malignant PLeural Effusion (AMPLE) Trial - 3: A Randomised Study Comparing Combined Indwelling Pleural Catheter (IPC) and Talc Pleurodesis with Video-Assisted Thoracoscopic Surgery (VATS) for the Management of Patients with Malignant Pleural Effusion
Institute for Respiratory Health0 个研究点目标入组 158 人开始时间: 2018年6月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 158
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Patients with a symptomatic MPE*
- •2. Predicted survival of more than 6 months
- •3. Eastern Cooperative Oncology Group (ECOG) score = Peformance status defined as a patient’s level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc. ECOG 0-1 (or ECOG greater than or equal to 2 if it is felt that removal of pleural fluid would improve their status to 0 or 1).
- •*MPE is defined as histologically/cytologically proven pleural malignancy or an otherwise unexplained pleural effusion in the context of clinically proven cancer elsewhere.
排除标准
- •1. Age <18 yrs
- •2. Unfit to undergo surgical procedure (American Society of Anaesthesiology Score = 4)
- •3. Significant loculations likely to preclude effective drainage via IPC
- •4. Pleural infection
- •5. Chylothorax
- •6.Pregnancy or lactation
- •7. Un-correctable bleeding diathesis
- •8. Previous ipsilateral lobectomy/pneumonectomy
- •9.Inability to consent
- •10. Inability to comply with the protocol.
研究者
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