Davies, H.E., Mishra, E.K., Kahan, B.C., Wrightson, J.M., Stanton, A.E., Guhan, A., . . . Rahman, N.M. (2012). 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 : The Journal of the American Medical Association, 307(22), 2383-2389.

The objective of the study was to determine if indwelling pleural catheters (IPCs) are more effective than talc slurry pleurodesis via chest tube for relief of dyspnea.

Patients with symptomatic malignant pleural effusion requiring pleurodesis were randomized to either IPC or talc pleurodesis. IPCs were inserted, initial large-volume drainage was performed, and caregivers were trained in IPC management. Drainage was advised to be done three times weekly. The IPC was removed if significant drainage stopped for at least four weeks, with no evidence of fluid reaccumulation. Patients in the talc group were hospitalized and had percutaneous chest tube insertion and talc slurry pleurodesis with 4 g sterile high-grade talc, following published treatment guidelines. Patients were followed up for 12 months after randomization. Dyspnea measurement was recorded daily for 42 days and then at 10, 14, 18, 22, and 26 weeks, and at 9 and 12 months.

• The sampe was comprised of 96 patients.
• The mean patient age was 76 years (SD = 11.5 years).
• Of the 96 patients, 43.5% were males and 56.5% were females.
• Various cancer types were included in the sample, but breast and lung were most frequent.
• The average size of effusion on radiography as a hemothorax was 51% in the IPC group and 49% in the talc group.
   

The study was conducted in multiple settings in the United Kingdom.

• Patients were undergoing late effects and survivorship care.
• The study has clinical applicability for palliative care.

The study was an unblinded, randomized controlled trial.

• 100 mm Visual Analogue Scale (VAS) for dyspnea
• EORTC - Quality of Life Questionnaire
• Complication recording
• Use of healthcare resources
   

• No significant difference in dyspnea was observed between groups.
• Dyspnea declined in both groups, with a mean decrease of 37.0 mm with IPC and 30.2 mm with talc. 
• At 6 months, a clinically significant decrease was seen in dyspnea in the IPC group compared to the talc group ( - 14.0 mm, p = .01). 
• Over 12 months, the IPC group spent an average of one day in the hospital for drainage or complications, compared to an average of 4.5 days in the talc group (p < .001).
• Global quality of life improved in both groups, with no significant difference between groups at any time point.
• In the IPC group, 40% experienced any adverse event, compared to 13% in the talc group (p = .002). 
• No difference in serious adverse events was observed between groups. 
• Pleural infections occurring with IPCs were asymptomatic and treated with oral antibiotics, and no IPC had to be removed for infection.

• Both talc pleurodesis and IPC were effective in reducing dyspnea in patients with malignant pleural effusion. 
• No significant difference in effectiveness was seen between the two approaches.
• IPCs reduce hospitalization time but are associated with more adverse events.

Because it was unblinded, the study had the risk of bias.

• Both approaches demonstrated effectiveness for reducing dyspnea in this group of patients. 
• Patient selection for IPC use needs to include consideration of caregiving needs and capabilities to manage the catheter, given the tendency for higher adverse events with its use.