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

NCT ID: NCT02045121

Last Updated: 2014-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-05-31

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.

Conditions

Pleural Effusion, Malignant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Indwelling Pleural Catheter

Day-case IPC insertion. Attendance d10 for drainage, stitch removal and education in catheter care.

Group Type: EXPERIMENTAL

Indwelling Pleural Catheter

Intervention Type: DEVICE

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.

Group Type: ACTIVE_COMPARATOR

Talc Pleurodesis

Intervention Type: PROCEDURE

Interventions

Indwelling Pleural Catheter

Intervention Type: DEVICE

Talc Pleurodesis

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Medicine

A/Prof Lee Pyng

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pyng Lee, MBBS, MRCP, MMED, FAMS, FCCP

Role: PRINCIPAL_INVESTIGATOR

National University of Singapore

Locations

Division of Respiratory and Critical Care Medicine, National University Hospital

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Pyng Lee, MBBS, MRCP, MMED, FAMS, FCCP

Role: CONTACT

mdclp@nus.edu.sg

Facility Contacts

Pyng Lee

Role: primary

mdclp@nus.edu.sg

65-67726533

References

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 18565960 (View on PubMed)

West 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.

Reference Type: BACKGROUND

PMID: 16716822 (View on PubMed)

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. doi: 10.1378/chest.117.1.73.

Reference Type: BACKGROUND

PMID: 10631202 (View on PubMed)

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. doi: 10.1378/chest.117.1.79.

Reference Type: BACKGROUND

PMID: 10631203 (View on PubMed)

Robinson 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.

Reference Type: BACKGROUND

PMID: 16054941 (View on PubMed)

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. doi: 10.1378/chest.127.3.909.

Reference Type: BACKGROUND

PMID: 15764775 (View on PubMed)

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. No abstract available.

Reference Type: BACKGROUND

PMID: 18587029 (View on PubMed)

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. No abstract available.

Reference Type: BACKGROUND

PMID: 21623256 (View on PubMed)

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. doi: 10.1016/j.lungcan.2005.05.016.

Reference Type: BACKGROUND

PMID: 15998551 (View on PubMed)

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. doi: 10.1183/09031936.00164706. Epub 2007 Jun 13.

Reference Type: BACKGROUND

PMID: 17567670 (View on PubMed)

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. doi: 10.1016/s0003-4975(99)01482-4.

Reference Type: BACKGROUND

PMID: 10735665 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10570423 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21325982 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20697963 (View on PubMed)

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. No abstract available.

Reference Type: BACKGROUND

PMID: 20880866 (View on PubMed)

Janes SM, Rahman NM, Davies RJ, Lee YC. Catheter-tract metastases associated with chronic indwelling pleural catheters. Chest. 2007 Apr;131(4):1232-4. doi: 10.1378/chest.06-2353.

Reference Type: BACKGROUND

PMID: 17426232 (View on PubMed)

Fysh ET, Thomas R, Read CA, Kwan BC, Yap E, Horwood FC, Lee P, Piccolo F, Shrestha R, Garske LA, Lam DC, Rosenstengel A, Bint M, Murray K, Smith NA, Lee YC. Protocol of the Australasian Malignant Pleural Effusion (AMPLE) trial: a multicentre randomised study comparing indwelling pleural catheter versus talc pleurodesis. BMJ Open. 2014 Nov 6;4(11):e006757. doi: 10.1136/bmjopen-2014-006757.

Reference Type: DERIVED

PMID: 25377015 (View on PubMed)

Other Identifiers

HSRG/0042/2013

Identifier Type: -

Identifier Source: org_study_id