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

A Multicentre Randomised Study Comparing Indwelling Pleural Catheter With Talc Pleurodesis in Patients With a Malignant Pleural Effusion

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02045121
Enrollment
160
Registered
2014-01-24
Start date
2014-01-31
Completion date
2015-05-31
Last updated
2014-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleural Effusion, Malignant

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.

Interventions

Sponsors

National University Hospital, Singapore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of hospital days for all causes following interventionUp to 1 year

Secondary

MeasureTime frame
Number of hospital days computed for pleural effusion related causeUp to 1 year
Number of adverse eventsUp to 1 year
Breathlessness scoreUp to 1 year
Self-reported quality of life scoresUp to 1 year
Health costs computationUp to 1 year

Countries

Singapore

Contacts

Primary ContactPyng Lee, MBBS, MRCP, MMED, FAMS, FCCP
mdclp@nus.edu.sg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026