Pleural Effusion, MalignantNCT02045121
Multicentre Study Comparing Indwelling Pleural Catheter With Talc Pleurodesis for Malignant Pleural Effusion Management
A study testing Indwelling Pleural Catheter and Talc Pleurodesis in people with Pleural Effusion, Malignant, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pleural Effusion, Malignant
- What is being tested?
- Indwelling Pleural Catheter and Talc Pleurodesis
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic malignant pleural effusion requiring intervention
Who cannot join
- <18 years of age
- pregnant or lactating patients
- expected survival <3 months
- chylothorax
- previous attempted pleurodesis
- pleural infection
Show all 9Show fewer
- leukocytopaenia (<1.0 x 10^9/L)
- uncorrectable bleeding diathesis
- inability to give informed consent or comply with the protocol
Trial locations and contacts
1 site in 1 country.
Pyng Lee, MBBS, MRCP, MMED, FAMS, FCCP contact
Singapore1 site, 1 recruiting
- Recruiting
Division of Respiratory and Critical Care Medicine, National University Hospital
Singapore, 119228
Pyng Lee, 65-67726533, mdclp@nus.edu.sg
Pyng Lee, MBBS, MRCP, MMED, FAMS, FCCP
About this study
Official title: A Multicentre Randomised Study Comparing Indwelling Pleural Catheter With Talc Pleurodesis in Patients With a Malignant Pleural Effusion
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.
- Conditions
- Pleural Effusion, Malignant
- Being tested
- Indwelling Pleural Catheter, Talc Pleurodesis
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indwelling Pleural CatheterDevice
Talc PleurodesisProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Indwelling Pleural Catheter | Experimental | Day-case IPC insertion. Attendance d10 for drainage, stitch removal and education in catheter care. Receives: Device: Indwelling Pleural Catheter |
| Talc Pleurodesis | Active comparator | 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. Receives: Procedure: Talc Pleurodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospital days for all causes following intervention
Measured: Up to 1 year
Secondary outcomes (5)
Number of hospital days computed for pleural effusion related cause
Measured: Up to 1 year
Number of adverse events
Measured: Up to 1 year
Breathlessness score
Measured: Up to 1 year
Self-reported quality of life scores
Measured: Up to 1 year
Health costs computation
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Pleural Effusion, MalignantStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Medicine, National University Hospital, Singapore
- Investigators
- Pyng Lee, MBBS, MRCP, MMED, FAMS, FCCP, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045121
- Sponsor's protocol ID
- HSRG/0042/2013
- Status last verified
- Jan 2014
- First submitted
- 9 Jan 2014
- Last updated
- 24 Jan 2014
- Results posted
- No
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.
Lee YC, Wilkosz S. Malignant pleural effusions: fixing the leaky faucet. Am J Respir Crit Care Med. 2008 Jul 1;178(1):3-5. doi: 10.1164/rccm.200804-616ED. No abstract available.
PubMed 18565960West SD, Lee YC. Management of malignant pleural mesothelioma. Clin Chest Med. 2006 Jun;27(2):335-54. doi: 10.1016/j.ccm.2006.01.004.
PubMed 16716822Burrows CM, Mathews WC, Colt HG. Predicting survival in patients with recurrent symptomatic malignant pleural effusions: an assessment of the prognostic values of physiologic, morphologic, and quality of life measures of extent of disease. Chest. 2000 Jan;117(1):73-8. doi: 10.1378/chest.117.1.73.
PubMed 10631202Heffner JE, Nietert PJ, Barbieri C. Pleural fluid pH as a predictor of survival for patients with malignant pleural effusions. Chest. 2000 Jan;117(1):79-86. doi: 10.1378/chest.117.1.79.
PubMed 10631203Robinson BW, Musk AW, Lake RA. Malignant mesothelioma. Lancet. 2005 Jul 30-Aug 5;366(9483):397-408. doi: 10.1016/S0140-6736(05)67025-0.
PubMed 16054941Dresler CM, Olak J, Herndon JE 2nd, Richards WG, Scalzetti E, Fleishman SB, Kernstine KH, Demmy T, Jablons DM, Kohman L, Daniel TM, Haasler GB, Sugarbaker DJ; Cooperative Groups Cancer and Leukemia Group B; Eastern Cooperative Oncology Group; North Central Cooperative Oncology Group; Radiation Therapy Oncology Group. Phase III intergroup study of talc poudrage vs talc slurry sclerosis for malignant pleural effusion. Chest. 2005 Mar;127(3):909-15. doi: 10.1378/chest.127.3.909.
PubMed 15764775Davies HE, Lee YC, Davies RJ. Pleurodesis for malignant pleural effusion: talc, toxicity and where next? Thorax. 2008 Jul;63(7):572-4. doi: 10.1136/thx.2007.092940. No abstract available.
PubMed 18587029Lee YC, Fysh ET. Indwelling pleural catheter: changing the paradigm of malignant effusion management. J Thorac Oncol. 2011 Apr;6(4):655-7. doi: 10.1097/JTO.0b013e3182114aa0. No abstract available.
PubMed 21623256van den Toorn LM, Schaap E, Surmont VF, Pouw EM, van der Rijt KC, van Klaveren RJ. Management of recurrent malignant pleural effusions with a chronic indwelling pleural catheter. Lung Cancer. 2005 Oct;50(1):123-7. doi: 10.1016/j.lungcan.2005.05.016.
PubMed 15998551Tremblay A, Mason C, Michaud G. Use of tunnelled catheters for malignant pleural effusions in patients fit for pleurodesis. Eur Respir J. 2007 Oct;30(4):759-62. doi: 10.1183/09031936.00164706. Epub 2007 Jun 13.
PubMed 17567670Putnam JB Jr, Walsh GL, Swisher SG, Roth JA, Suell DM, Vaporciyan AA, Smythe WR, Merriman KW, DeFord LL. Outpatient management of malignant pleural effusion by a chronic indwelling pleural catheter. Ann Thorac Surg. 2000 Feb;69(2):369-75. doi: 10.1016/s0003-4975(99)01482-4.
PubMed 10735665Putnam JB Jr, Light RW, Rodriguez RM, Ponn R, Olak J, Pollak JS, Lee RB, Payne DK, Graeber G, Kovitz KL. A randomized comparison of indwelling pleural catheter and doxycycline pleurodesis in the management of malignant pleural effusions. Cancer. 1999 Nov 15;86(10):1992-9.
PubMed 10570423Suzuki K, Servais EL, Rizk NP, Solomon SB, Sima CS, Park BJ, Kachala SS, Zlobinsky M, Rusch VW, Adusumilli PS. Palliation and pleurodesis in malignant pleural effusion: the role for tunneled pleural catheters. J Thorac Oncol. 2011 Apr;6(4):762-7. doi: 10.1097/JTO.0b013e31820d614f.
PubMed 21325982
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomised Study Comparing Indwelling Pleural Catheter With Talc Pleurodesis in Patients With a Malignant Pleural Effusion
- ClinicalTrials.gov ID
- NCT02045121
- Acronym / sponsor ID
- HSRG/0042/2013
- Conditions
- Pleural Effusion, Malignant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 24 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indwelling Pleural Catheter | Experimental | Device: Indwelling Pleural CatheterDay-case IPC insertion. Attendance d10 for drainage, stitch removal and education in catheter care. |
| Talc Pleurodesis | Active comparator | Procedure: Talc PleurodesisHospital 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic malignant pleural effusion requiring intervention
Key exclusion criteria (9 listed)
- <18 years of age
- pregnant or lactating patients
- expected survival <3 months
- chylothorax
- previous attempted pleurodesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indwelling Pleural Catheter | Device | Indwelling Pleural Catheter |
| Talc Pleurodesis | Procedure or surgery | Talc Pleurodesis |
Primary outcome
Number of hospital days for all causes following intervention
Time frame: Up to 1 year
5 secondary outcomes
Number of hospital days computed for pleural effusion related cause
Time frame: Up to 1 year
Number of adverse events
Time frame: Up to 1 year
Breathlessness score
Time frame: Up to 1 year
Self-reported quality of life scores
Time frame: Up to 1 year
Health costs computation
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2014.
- BackgroundDavies HE, Lee YCG. Pleurodesis. In: Light RW, Lee YCG, eds. Textbook of Pleural Diseases. 2nd ed. London, U.K.: Arnold Press; 2008:569-82.
- BackgroundMishra 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.
- Background: PubMed 18565960Lee YC, Wilkosz S. Malignant pleural effusions: fixing the leaky faucet. Am J Respir Crit Care Med. 2008 Jul 1;178(1):3-5. doi: 10.1164/rccm.200804-616ED. No abstract available.
- Background: PubMed 16716822West SD, Lee YC. Management of malignant pleural mesothelioma. Clin Chest Med. 2006 Jun;27(2):335-54. doi: 10.1016/j.ccm.2006.01.004.
- Background: PubMed 10631202Burrows CM, Mathews WC, Colt HG. Predicting survival in patients with recurrent symptomatic malignant pleural effusions: an assessment of the prognostic values of physiologic, morphologic, and quality of life measures of extent of disease. Chest. 2000 Jan;117(1):73-8. doi: 10.1378/chest.117.1.73.
- Background: PubMed 10631203Heffner JE, Nietert PJ, Barbieri C. Pleural fluid pH as a predictor of survival for patients with malignant pleural effusions. Chest. 2000 Jan;117(1):79-86. doi: 10.1378/chest.117.1.79.
- Background: PubMed 16054941Robinson BW, Musk AW, Lake RA. Malignant mesothelioma. Lancet. 2005 Jul 30-Aug 5;366(9483):397-408. doi: 10.1016/S0140-6736(05)67025-0.
- Background: PubMed 15764775Dresler CM, Olak J, Herndon JE 2nd, Richards WG, Scalzetti E, Fleishman SB, Kernstine KH, Demmy T, Jablons DM, Kohman L, Daniel TM, Haasler GB, Sugarbaker DJ; Cooperative Groups Cancer and Leukemia Group B; Eastern Cooperative Oncology Group; North Central Cooperative Oncology Group; Radiation Therapy Oncology Group. Phase III intergroup study of talc poudrage vs talc slurry sclerosis for malignant pleural effusion. Chest. 2005 Mar;127(3):909-15. doi: 10.1378/chest.127.3.909.
- Background: PubMed 18587029Davies HE, Lee YC, Davies RJ. Pleurodesis for malignant pleural effusion: talc, toxicity and where next? Thorax. 2008 Jul;63(7):572-4. doi: 10.1136/thx.2007.092940. No abstract available.
- Background: PubMed 21623256Lee YC, Fysh ET. Indwelling pleural catheter: changing the paradigm of malignant effusion management. J Thorac Oncol. 2011 Apr;6(4):655-7. doi: 10.1097/JTO.0b013e3182114aa0. No abstract available.
- Background: PubMed 15998551van den Toorn LM, Schaap E, Surmont VF, Pouw EM, van der Rijt KC, van Klaveren RJ. Management of recurrent malignant pleural effusions with a chronic indwelling pleural catheter. Lung Cancer. 2005 Oct;50(1):123-7. doi: 10.1016/j.lungcan.2005.05.016.
- Background: PubMed 17567670Tremblay A, Mason C, Michaud G. Use of tunnelled catheters for malignant pleural effusions in patients fit for pleurodesis. Eur Respir J. 2007 Oct;30(4):759-62. doi: 10.1183/09031936.00164706. Epub 2007 Jun 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pyng Lee, MBBS, MRCP, MMED, FAMS, FCCP contact
Pyng Lee, MBBS, MRCP, MMED, FAMS, FCCP principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indwelling Pleural Catheter and Talc Pleurodesis in people with Pleural Effusion, Malignant, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pyng Lee, MBBS, MRCP, MMED, FAMS, FCCP (mdclp@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hospital days for all causes following intervention (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02045121, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2014.