Indwelling pleural catheter vs chest tube and talc pleurodesis for malignant pleural effusion
TIME2 trial design and results
Design
Randomised controlled trial
Treatment
Indwelling pleural catheter
Control
Chest tube and talc pleurodesis
Population
106 patients with malignant pleural effusion and no previous pleurodesis
Follow-up
12 months
Primary endpoint
Mean daily breathlessness on a visual analogue scale over the first 42 days
Result
Mean VAS dyspnoea over 42 days was 24.7 mm (95% CI 19.3 to 30.1) with a catheter and 24.4 mm (19.4 to 29.4) with talc — difference 0.16 mm (95% CI -6.82 to 7.15, p=0.96). At 6 months dyspnoea favoured the catheter by -14.0 mm (95% CI -25.2 to -2.8, p=0.01). Median initial hospitalisation was 0 days (IQR 0-1) versus 4 days (IQR 2-6), difference -3.5 days (p<0.001). Further pleural procedures were needed in 3 of 52 (6%) with a catheter versus 12 of 54 (22%) with talc (OR 0.21, p=0.03). Adverse events, however, affected 21 of 52 (40%) in the catheter group versus 7 of 54 (13%) with talc — OR 4.70 (95% CI 1.75 to 12.60, p=0.002).
Secondary endpoints
Dyspnoea at 6 months, length of hospitalisation, quality of life, adverse events
Among patients with malignant pleural effusion and no previous pleurodesis, there was no significant difference between IPCs and talc pleurodesis at relieving patient-reported dyspnea.
The trial authors, in the published abstract
How it has aged
The primary endpoint was negative and the practice-changing findings were secondary: no initial hospital stay, fewer repeat procedures, and better breathlessness by six months. Set against that is a near-fivefold excess of adverse events in the catheter arm, which the enthusiasm for catheters often passes over. AMPLE later made days in hospital the primary endpoint and confirmed the advantage, which is the more honest test for a palliative intervention.
Publications
Effect of an indwelling pleural catheter vs chest tube and talc pleurodesis for relieving dyspnea in patients with malignant pleural effusion: the TIME2 randomized controlled trial
Davies HE, Mishra EK, Kahan BC, et al. Effect of an indwelling pleural catheter vs chest tube and talc pleurodesis for relieving dyspnea in patients with malignant pleural effusion: the TIME2 randomized controlled trial. JAMA 2012 Jun 13;307(22):2383-9.
No difference in breathlessness over the first 42 days
Better dyspnoea scores at 6 months with the catheter
Median initial hospitalisation of 0 days with a catheter