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Pleural disease · Malignant pleural effusion

AMPLE

Australasian Malignant Pleural Effusion trial

AMPLE trial design and results
Design Randomised trial
Treatment Indwelling pleural catheter
Control Talc pleurodesis
Population 146 patients with malignant pleural effusion, median age 70.5 years
Follow-up 12 months
Primary endpoint Total number of days spent in hospital from intervention to death or 12 months
Result Median hospital days 10.0 (IQR 3-17) with an indwelling catheter versus 12.0 (IQR 7-21) with pleurodesis (p=0.03; Hodges-Lehmann difference 2.92 days, 95% CI 0.43 to 5.84). The difference was driven by effusion-related days: median 1.0 (IQR 1-3) versus 4.0 (IQR 3-6), p<0.001.
Secondary endpoints Effusion-related hospital days, breathlessness, quality of life, adverse events

The indwelling pleural catheter group spent significantly fewer days in hospital than the pleurodesis group.

The trial authors, in the published abstract

How it has aged

Chose the right endpoint for a palliative intervention — days at home, not radiographic success. For patients with limited life expectancy that reframing is the whole argument, and it is why catheters are now a first-line option rather than a salvage one. See TAPPS for the choice within pleurodesis.

Publications

Effect of an Indwelling Pleural Catheter vs Talc Pleurodesis on Hospitalization Days in Patients With Malignant Pleural Effusion: The AMPLE Randomized Clinical Trial

Thomas R, Fysh ETH, Smith NA, et al. Effect of an Indwelling Pleural Catheter vs Talc Pleurodesis on Hospitalization Days in Patients With Malignant Pleural Effusion: The AMPLE Randomized Clinical Trial. JAMA 2017 Nov 21;318(19):1903-1912.

  • Median hospital stay shorter by about three days over 12 months
  • Effusion-related hospital days reduced from 4 to 1