TAPPS.

Trial name or title	Evaluating the efficacy of thoracoscopy and talc poudrage versus pleurodesis using talc slurry: a randomised trial to determine the most effective method for the management of malignant pleural effusions in patients with a good performance status (The TAPPS Study)
Methods	The TAPPS trial is a multi‐centre randomised controlled study which compares the efficacy of chest drain insertion and talc slurry instillation with local anaesthetic thoracoscopy and talc poudrage, in the management of malignant pleural effusions
Participants	Inclusion: clinically confident diagnosis of malignant pleural effusion requiring pleurodesis; fit enough to undergo local anaesthetic thoracoscopy; expected survival > 3 months Exclusion: patients requiring a thoracoscopy to make a diagnosis; age < 18 years; pregnancy or lactation; evidence of extensive lung entrapment; insufficient pleural fluid to safely perform local anaesthetic thoracoscopy; adverse reaction to talc; contraindication to thoracoscopy or chest tube insertion Aiming to recruit 330 participants.
Interventions	Control arm: 12 ‐ 14 Fr seldinger drain, then 4 g talc slurry pleurodesis Intervention arm: medical thoracoscopy, with 4 g talc poudrage at end of the procedure
Outcomes	Primary endpoint: the number of participants who experience pleurodesis failure up to three months (90 days) post randomisation Secondary endpoints: requirement for further pleural procedures up to six months post‐randomisation; percentage radiographic (chest X‐ray) pleural opacification at 1, 3 and 6 months post randomisation; quality of life; thoracic pain; breathlessness; pleurodesis failure at 1 and 6 months; mortality
Starting date	26 September 2012
Contact information	rbhatnagar@doctors.org.uk
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