A randomized controlled trial comparing indwelling pleural catheters with talc pleurodesis (NVALT-14)

Background: Symptomatic malignant pleural effusion (MPE) occurs frequently in patients with metastatic cancer. The associated prognosis is poor and the success rate of talc pleurodesis (TP) is low. Indwelling pleural catheters (IPCs) are commonly inserted when TP has been unsuccessful. Methods: We compared talc pleurodesis with the use of an indwelling pleural catheter in patients with recurrent MPE in a multicenter randomized controlled trial (superiority design). The primary endpoint was improvement from baseline in Modified Borg Score (MBS) 6 weeks after randomized treatment. Secondary endpoints were hospitalization days, re-interventions, and adverse events. Results: Dyspnea improved significantly (p <0.01) after either treatment, but the magnitude of this improvement did not differ significantly between arms (median 3 and 1 for TP:IPC respectively in rest, p = 0.16,(TP 13:IPC 16)and 3 and 1 during exercise, p = 0.72 (TP 13:IPC 17)). There was no difference in dyspnea during exercise between TP and IPC at week 6 following treatment, while at rest TP patients (n = 13) reported less dyspnea than IPC patients (n = 18) (median 0 vs 1, p = 0.002). Compared to TP, patients with an IPC had significantly less hospital days during randomized treatment (median: 0 vs 5, p