Clinical trial NCT02045121: Multicentre Study Comparing Indwelling Pleural Catheter With Talc Pleurodesis for Malignant Pleural Effusion Management
Official title: A Multicentre Randomised Study Comparing Indwelling Pleural Catheter With Talc Pleurodesis in Patients With a Malignant Pleural Effusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pleural Effusion, Malignant
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2014-01-24
Enrollment: 160
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of hospital days for all causes following intervention
timeFrame: Up to 1 year
Secondary outcomes:
measure: Number of hospital days computed for pleural effusion related cause
timeFrame: Up to 1 year
measure: Number of adverse events
timeFrame: Up to 1 year
measure: Breathlessness score
timeFrame: Up to 1 year
measure: Self-reported quality of life scores
timeFrame: Up to 1 year
measure: Health costs computation
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Division of Respiratory and Critical Care Medicine, National University Hospital
Study officials:
affiliation: National University of Singapore
name: Pyng Lee, MBBS, MRCP, MMED, FAMS, FCCP
role: PRINCIPAL_INVESTIGATOR
References:
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