Multicentre Study Comparing Indwelling Pleural Catheter With Talc Pleurodesis for Malignant Pleural Effusion Management

National University Health System (NUHS)

Status: Unknown

Conditions: Pleural Effusion, Malignant

Treatments: Device: Indwelling Pleural Catheter; Procedure: Talc Pleurodesis

Study type: Interventional

Funder types: Other

Identifiers

NCT02045121

HSRG/0042/2013

Details and patient eligibility

About

Malignant pleural effusion (MPE) accounts for 50% of all pleural effusions and affects about 300,000 patients annually (UK and USA). Lung and breast cancers account for majority of malignant pleural effusions; 1 in 3 breast cancer, 1 in 4 lung cancer as well as > 90% of patients with mesothelioma develop pleural effusions. Breathlessness from MPE is disabling and impairs quality of life. Median survival ranges between 4-6 months. Although thoracentesis provides effective symptom relief, most effusions recur and pleurodesis is the standard of care. Pleurodesis can be performed via chest tube or applied during pleuroscopy, and talc is the most effective agent. For successful pleurodesis to occur the underlying lung must expand after fluid drainage and trapped lung due to metastatic disease occurs up to 30%. Symptomatic patients require hospitalization for these procedures which are likely to fail if trapped lungs are encountered, and pose significant burden to health services. Tunneled indwelling pleural catheter (IPC) is emerging as a viable alternative which provides access to the pleural space for fluid drainage when breathlessness arise. IPC can be performed at ambulatory setting without hospital admission. Case series have demonstrated long-term safety of IPC even in patients undergoing chemotherapy with acceptable complication rates. By keeping the pleural cavity free of fluid, IPC has led to spontaneous pleurodesis in 50% of patients, which allows its removal. Presently IPC is indicated for trapped lung or when talc pleurodesis has failed. A randomised comparative trial with talc pleurodesis is necessary to determine role of IPC as first-line therapy of MPE, if IPC leads to reduction in hospitalizations, adverse events and healthcare costs, and if it improves quality of life. The multicenter trial randomizes symptomatic patients 1:1 to IPC or talc pleurodesis, and endpoints include hospitalization days till death or end of study, adverse events, quality of life, and healthcare costs.

Enrollment: 160 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic malignant pleural effusion requiring intervention

Exclusion criteria

• <18 years of age
• pregnant or lactating patients
• expected survival <3 months
• chylothorax
• previous attempted pleurodesis
• pleural infection
• leukocytopaenia (<1.0 x 10^9/L)
• uncorrectable bleeding diathesis
• inability to give informed consent or comply with the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Indwelling Pleural Catheter

Experimental group

Description:

Day-case IPC insertion. Attendance d10 for drainage, stitch removal and education in catheter care.

Treatment:

Device: Indwelling Pleural Catheter

Talc Pleurodesis

Active Comparator group

Description:

Hospital admission for chest drain insertion and suction if needed, plus talc pleurodesis by slurry or poudrage if \>75% of visceral and parietal pleura in direct contact on chest x-ray.

Treatment:

Procedure: Talc Pleurodesis