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

Pleural Effusion, Malignant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02045121
• Other study ID #: HSRG/0042/2013
• Status: Recruiting
• Phase: N/A
• First received: January 9, 2014
• Last updated: January 22, 2014
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: January 2014
• Source: National University Hospital, Singapore
• Contact: Pyng Lee, MBBS, MRCP, MMED, FAMS, FCCP
• Email: mdclp[@]nus.edu.sg
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review BoardsSingapore: Ministry of Health
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Device:
• Indwelling Pleural Catheter

Procedure:
• Talc Pleurodesis

Locations

Country	Name	City	State
Singapore	Division of Respiratory and Critical Care Medicine, National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (18)

Burrows 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. — View Citation

Davies 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. — View Citation

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.

Dresler 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. — View Citation

Heffner 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. — View Citation

Janes SM, Rahman NM, Davies RJ, Lee YC. Catheter-tract metastases associated with chronic indwelling pleural catheters. Chest. 2007 Apr;131(4):1232-4. — View Citation

Lee 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. — View Citation

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. — View Citation

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.

Morel A, Mishra E, Medley L, Rahman NM, Wrightson J, Talbot D, Davies RJ. Chemotherapy should not be withheld from patients with an indwelling pleural catheter for malignant pleural effusion. Thorax. 2011 May;66(5):448-9. doi: 10.1136/thx.2009.133504. Epub 2010 Sep 29. — View Citation

Putnam 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. — View Citation

Putnam 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. — View Citation

Robinson BW, Musk AW, Lake RA. Malignant mesothelioma. Lancet. 2005 Jul 30-Aug 5;366(9483):397-408. Review. — View Citation

Suzuki 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. — View Citation

Tremblay 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. Epub 2007 Jun 13. — View Citation

van 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. — View Citation

Van Meter ME, McKee KY, Kohlwes RJ. Efficacy and safety of tunneled pleural catheters in adults with malignant pleural effusions: a systematic review. J Gen Intern Med. 2011 Jan;26(1):70-6. doi: 10.1007/s11606-010-1472-0. Epub 2010 Aug 10. Review. — View Citation

West SD, Lee YC. Management of malignant pleural mesothelioma. Clin Chest Med. 2006 Jun;27(2):335-54. Review. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of hospital days for all causes following intervention		Up to 1 year	No
Secondary	Number of hospital days computed for pleural effusion related cause		Up to 1 year	No
Secondary	Number of adverse events		Up to 1 year	Yes
Secondary	Breathlessness score		Up to 1 year	No
Secondary	Self-reported quality of life scores		Up to 1 year	No
Secondary	Health costs computation		Up to 1 year	No