Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pleural Effusion, Malignant | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indwelling Pleural Catheter | Device | — | UNRESOLVED |
| Talc Pleurodesis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Indwelling Pleural Catheter
- description
- Day-case IPC insertion. Attendance d10 for drainage, stitch removal and education in catheter care.
- interventionNames
- Device: Indwelling Pleural Catheter
- type
- ACTIVE_COMPARATOR
- label
- Talc Pleurodesis
- description
- 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.
- interventionNames
- Procedure: Talc Pleurodesis
Primary outcomes (1)
- measure
- Number of hospital days for all causes following intervention
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (19)
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- 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.
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- BACKGROUNDWest 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. PMID 16716822
- BACKGROUNDBurrows 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. PMID 10631202
- BACKGROUNDHeffner 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. PMID 10631203
- BACKGROUNDRobinson 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. PMID 16054941
- BACKGROUNDDresler 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.