NCT00821860已完成3 期
Prospective Randomised Controlled Trial of Video-Assisted Thoracoscopic (VAT) Cytoreductive Pleurectomy Compared to Talc Pleurodesis in Patients With Suspected or Proven Malignant Mesothelioma
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 10
- 主要终点
- Survival at 1 year after treatment
研究概览
简要总结
RATIONALE: Video-assisted surgery to remove part of the tissue layer covering the inside of the chest cavity may be effective in treating pleural effusion and cause less damage to normal tissue. Talc pleurodesis may keep fluid from building up in the chest cavity. It is not yet known which therapy is more effective in treating pleural effusion caused by malignant mesothelioma.
PURPOSE: This randomized phase III trial is studying video-assisted surgery to see how well it works compared with talc pleurodesis in treating patients with malignant mesothelioma.
详细描述
OBJECTIVES:
Primary
- Compare the effectiveness of video-assisted thoracoscopic cytoreductive pleurectomy vs talc pleurodesis, in terms of 1-year survival, in patients with suspected or proven malignant mesothelioma.
Secondary
- Compare the control of pleural effusion in these patients.
- Compare procedure-related complications in these patients.
- Compare the symptoms and quality of life of these patients at 3, 6, and 12 months after treatment.
- Compare the length of hospital stay for these patients.
- Compare the exercise tolerance of these patients at 3, 6, and 12 months after treatment.
- Determine the cost to the health service, in terms of resources used for procedures, hospital bed usage, and cost of primary and secondary care over 12 months.
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
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Survival at 1 year after treatment
时间窗: 1 year
次要结局
- Control of pleural effusion(1 year)
- Complications, including need for more surgery, persistent air leak requiring pleural intubation for > 10 days, and hospital stay for > 12 days(1 year)
- Symptoms and quality of life as assessed by the EuroQol questionnaire(0, 1, 3, 6 12 months)
- Length of hospital stay(1 year)
- Exercise tolerance(0, 1, 3, 6 12 months)
- Cost to the health service, in terms of resources used for procedures, hospital bed usage, and cost of primary and secondary care over 12 months(0, 1, 3, 6 12 months)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
3 期
Conventional or Video-Assisted Surgery in Treating Patients With Lung MetastasesMetastatic CancerNCT00003724Alliance for Clinical Trials in Oncology530
撤回
不适用
Randomized, Blinded, Controlled Clinical Trial of Surgically Facilitated Orthodontic TreatmentOrthodontic MalocclusionNCT01866345University of Minnesota
招募中
不适用
An Informative Video Before Planned External Cephalic VersionBreech PresentationNCT06187948Meir Medical Center200
已完成
不适用
Debulking surgery and hyperthermic chemotherapy for pleural mesothelioma: a pilot study.Malignant pleural mesotheliomaCancerISRCTN12709516niversity of Catania27
Unknown
不适用
The Effect of Hair Removal on Intraoperative ContaminationIntraoperative ComplicationsNCT04256928Herlev and Gentofte Hospital200