Prospective Randomised Controlled Trial of Video-Assisted Thoracoscopic (VAT) Cytoreductive Pleurectomy Compared to Talc Pleurodesis in Patients With Suspected or Proven Malignant Mesothelioma
- Compare the effectiveness of video-assisted thoracoscopic cytoreductive pleurectomy vs
talc pleurodesis, in terms of 1-year survival, in patients with suspected or proven
- 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
- Compare the length of hospital stay for these patients.
- Compare the exercise tolerance of these patients at 3, 6, and 12 months after
- 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.
OUTLINE: This is a multicenter study. Patients are stratified according to risk (high vs
low). Patients are randomized to 1 of 2 treatment arms.
- Arm I (video-assisted thoracoscopic [VAT] cytoreductive pleurectomy): Patients undergo
VAT cytoreductive pleurectomy either at the time of biopsy or after confirmation of
- Arm II (talc pleurodesis): Patients undergo talc pleurodesis via an indwelling
intercostal chest drain or via thoracoscopy either at the time of biopsy or after
confirmation of biopsy results.
Quality of life, complications, and resource use are assessed at baseline and at 1, 3, 6,
and 12 months.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Survival at 1 year after treatment
Robert Winter, MD
United Kingdom: Medicines and Healthcare Products Regulatory Agency