https://www.ncbi.nlm.nih.gov/pubmed/30037711
Clinical Trial
Reference: Muruganandan S, Azzopardi M, Fitzgerald DB, et al. Aggressive versus symptom-guided drainage of malignant pleural effusion via indwelling pleural catheters (AMPLE-2): an open-label randomised trial. Lancet Respir Med. 2018;6(9):671-680.
Background: IPCs are commonly used for the treatment of recurrent, symptomatic MPEs. This study sought to determine whether aggressive (daily) versus symptom driven drainage of IPCs was superior in providing control of dyspnea.
PICO:
Populations:
- Adult patients with symptomatic MPE with an IPC
- Excluded patients with: expected survival less than 3 months, pleural infection, chylothorax, pregnancy, lactation, uncorrectable bleeding diatheses, previous ipsilateral lobectomy or pneumonectomy, significant loculations, significant visual impairment and inability to consent
Intervention:
- Aggressive IPC drainage regimen (daily)
Comparison:
- Symptom-guided IPC drainage regimen
Outcome:
- Primary outcome: No significant difference between the two groups
- Patient-reported mean daily breathlessness in the first 60 days after randomization as measured on a 100mm VAS
- Secondary outcomes:
- Rates of spontaneous pleurodesis – Significantly higher in aggressive drainage group in first 60 days and after 6 months
- Self-reported global quality of life measured by the EQ-5D-5L and 100mm VAS at various time points – Aggressive drainage was associated with better EQ-5D-5L index values than symptom-guided drainage
- Total number of episodes and duration of hospital stay – No significant difference between groups
- Frequency of adverse events – No significant difference between groups
Take Home: This study found no significant differences between aggressive (daily) and symptom-guided drainage regimens for IPCs for providing control of dyspnea. This study also found that daily drainage of IPCs may be more effective in achieving spontaneous pleurodesis and may improve patient QoL.
Randomized Trial of Pleural Fluid Drainage Frequency in Patients with Malignant Pleural Effusions. The ASAP Trial
https://pubmed.ncbi.nlm.nih.gov/27898215/
Clinical Trial
Reference: Wahidi MM, Reddy C, Yarmus L, Feller-Kopman D, et al. Randomized Trial of Pleural Fluid Drainage Frequency in Patients with Malignant Pleural Effusions: The ASAP Trial. Am J Respir Crit Care Med 2017; 195(8):1050-1057.
Background: IPCs allow patients with MPE to drain pleural effusions at home, often leading to pleurodesis. The optimal drainage frequency to achieve pleurodesis and IPC removal was investigated further in this study. This study evaluated whether an aggressive daily drainage strategy was superior to every other day drainage in achieving pleurodesis.
PICO:
Populations:
- Inclusion criteria: Adult patients with a recurrent MPE in the setting of known malignancy with either confirmed pleural involvement or no other identifiable cause for recurrent pleural effusion after a thorough work-up. Patients were symptomatic and experienced improvement in symptoms after thoracentesis and worsening of symptoms when fluid recurred.
- Excluded patients with: expected survival less than 1 month, radiographic evidence of trapped lung, loculated pleural effusion, previous surgery or attempted pleurodesis on the affected side, chylothorax or pleural infection, inability to perform drainage at home, uncorrectable bleeding disorder, skin infection at site of intended catheter insertion and pregnancy.
Intervention:
- Every other day IPC drainage regimen (n=76)
Comparison:
- Aggressive IPC drainage regimen (daily) (n=73)
Outcome:
- Primary outcome: Significant increase in pleurodesis rates in the aggressive IPC drainage group when compared to the every other day IPC drainage group (P=0.003). Pleurodesis rates were based on symptomatic and radiographic changes. Median time to pleurodesis was shorter in the aggressive arm when compared to the standard arm.
- Secondary outcomes: Rates of adverse events, quality of life and patient satisfaction were not significantly different between the two groups.
Take Home: This study found that among patients with MPE and IPC placement, daily drainage of pleural fluid may lead to higher rates of pleurodesis and fewer days with IPC when compared to every other day drainage.
