TABLE 1.
Study (year) [ref.] | Design | Main positive findings | Secondary findings |
TIME 2 (2012) [53] | Unblinded randomised: IPC (n=52) versus ICD with talc pleurodesis (n=54) | IPC group: Improvement in dyspnoea in the IPC group at 6 months (p=0.01) Initial hospitalisation shorter (p<0.001) Less need for further interventions (p=0.03) |
No significant difference in: Dyspnoea after 42 days QoL |
ASAP (2016) [54] | Randomised: IPC daily drainage (n=73) versus standard drainage (alternative days, n=76) | Autopleurodesis Greater with daily drainage (47% versus 24%, p=0.003) Median time to autopleurodesis shorter with daily drainage (54 versus 90 days) |
No significant difference in: Rate of adverse events QoL Patient satisfaction |
AMPLE (2017) [55] | Open-label, randomised: IPC (n=74) versus talc pleurodesis (n=72) |
Hospitalisation days from treatment to death Median (IQR) 10.0 (3–17) in IPC group versus 12.0 (7–21) days in pleurodesis group (p=0.03) Fewer additional pleural procedures in IPC group |
No significant difference in: Improvements in breathlessness QoL |
AMPLE II (2018) [56] | Open-label randomised: IPC daily (n=43) versus symptom-guided drainage (n=44) |
Daily drainage group: No difference in breathlessness scores Autopleurodesis more likely at 3 (37.2% versus 11.4%, p=0.0049) and 6 months (44.2% versus 15.9%, p=0.004) Better patient-reported QoL measures |
No significant difference in: Rate of adverse events Pain scores Days in hospital Mortality |
IPC-Plus (2018) [57] | Randomised (only if no trapped lung at 10 days after IPC): 4 g of talc slurry (n=69) versus placebo (n=70) |
Talc group: Pleurodesis 43% in the talc group versus 23% (p=0.008) Better QoL and symptom control |
No significant difference in: Rate of adverse events Effusion size and complexity Number of inpatient days Mortality |
ICD: intercostal drain; QoL: quality of life; IQR: interquartile range.