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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02045121
Recruitment Status : Unknown
Verified January 2014 by Medicine, National University Hospital, Singapore.
Recruitment status was:  Recruiting
First Posted : January 24, 2014
Last Update Posted : January 24, 2014
Sponsor:
Information provided by (Responsible Party):
Medicine, National University Hospital, Singapore

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.

Condition or disease Intervention/treatment Phase
Pleural Effusion, Malignant Device: Indwelling Pleural Catheter Procedure: Talc Pleurodesis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre Randomised Study Comparing Indwelling Pleural Catheter With Talc Pleurodesis in Patients With a Malignant Pleural Effusion
Study Start Date : January 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Indwelling Pleural Catheter
Day-case IPC insertion. Attendance d10 for drainage, stitch removal and education in catheter care.
Device: Indwelling Pleural Catheter
Active Comparator: Talc Pleurodesis
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.
Procedure: Talc Pleurodesis



Primary Outcome Measures :
  1. Number of hospital days for all causes following intervention [ Time Frame: Up to 1 year ]

Secondary Outcome Measures :
  1. Number of hospital days computed for pleural effusion related cause [ Time Frame: Up to 1 year ]
  2. Number of adverse events [ Time Frame: Up to 1 year ]
  3. Breathlessness score [ Time Frame: Up to 1 year ]
  4. Self-reported quality of life scores [ Time Frame: Up to 1 year ]
  5. Health costs computation [ Time Frame: Up to 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045121


Contacts
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Contact: Pyng Lee, MBBS, MRCP, MMED, FAMS, FCCP mdclp@nus.edu.sg

Locations
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Singapore
Division of Respiratory and Critical Care Medicine, National University Hospital Recruiting
Singapore, Singapore, 119228
Contact: Pyng Lee    65-67726533    mdclp@nus.edu.sg   
Principal Investigator: Pyng Lee, MBBS, MRCP, MMED, FAMS, FCCP         
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
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Principal Investigator: Pyng Lee, MBBS, MRCP, MMED, FAMS, FCCP National University, Singapore

Publications:
Davies HE, Lee YCG. Pleurodesis. In: Light RW, Lee YCG, eds. Textbook of Pleural Diseases. 2nd ed. London, U.K.: Arnold Press; 2008:569-82.
Mishra E, Davies HE, Lee YCG. Malignant pleural disease in primary lung cancer. In: Spiro SG, Janes SM, Huber RM, eds. Thoracic Malignancies. 3rd ed ed. Sheffield, U.K.: European Respiratory Society Journals Ltd; 2009:318-35.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medicine, A/Prof Lee Pyng, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT02045121    
Other Study ID Numbers: HSRG/0042/2013
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: January 24, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Pleural Effusion, Malignant
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms