Clinical trial · Interventional
Management of Malignant Pleural Effusion With Indwelling Pleural Catheter Versus Silver Nitrate Pleurodesis
Management Of Malignant Pleural Effusion With Indwelling Pleural Catheter Versus Silver Nitrate Pleurodesis
NCT03781908CI-TRIAL-00036218unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The primary goal of this study is to compare well-defined pleural effusion management success outcomes in patients with malignant or paramalignant pleural effusions who were treated with Indwelling pleural catheter insertion compared with those treated with siver nitrate pleurodesis. It is also to demonstrate the effectiveness of silver nitrate pleurodesis. It is also important to evaluate frequent adverse events of silver nitrate pleurodesis in patients with malignant pleural effusion
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 |
| Silver Nitrate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Silver Nitrate Pleurodesis
- description
- Patients will receive 0.5% silver nitrate diluted in 50 ml distilled water with 10 ml of local anaesthetic lidocaine 1%
- interventionNames
- Drug: Silver Nitrate
- type
- ACTIVE_COMPARATOR
- label
- Indwelling Pleural Catheter
- description
- Catheters will be inserted in an outpatient setting under local anaesthesia.The typical drainage schedule is every other day using disposable plastic bottles (550 mL to 1 L)
- interventionNames
- Device: Indwelling Pleural Catheter
Primary outcomes (2)
- measure
- Success rate of silver nitrate pleurodesis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Unilateral symptomatic recurrent malignant pleural effusion patients who fulfill the criteria for pleurodesis (i.e. positive pleural biopsy or cytology for malignancy, a Karnofsky index score of more than 60 and life expectancy of more than one year). 2. Rapidly accumulated undiagnosed pleural effusion . 3. Age : 30-75 years old. Exclusion Criteria: 1. Transudative pleural effusion. 2. Exudative pleural effusion due to causes other than malignancy ( i.e. parapnuemonic , post-tuberculous pleural effusion ) 3. Presence of hemorrhagic diathesis ( prothrombin time \<50% and platelet count \<80,000/mm 3 ) 4. Active pleural or systemic infection. 5. Neoplastic infiltration of the skin at the site of pleural catheter insertion. 6. Malignant pleural effusion with trapped lung or loculated pleural effusion. 7. Previous lobectomy or pneumonectomy on the affected side. 8. Karnofsky index score\> 50.
References
Publications (9)
- BACKGROUNDKalomenidis I. Beyond talc pleurodesis: do we really need new methods? Respirology. 2011 Oct;16(7):1020-2. doi: 10.1111/j.1440-1843.2011.02023.x. No abstract available. PMID 21790880
- BACKGROUNDRoberts ME, Neville E, Berrisford RG, Antunes G, Ali NJ; BTS Pleural Disease Guideline Group. Management of a malignant pleural effusion: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii32-40. doi: 10.1136/thx.2010.136994. No abstract available. PMID 20696691
- BACKGROUNDTremblay A, Stather DR, Kelly MM. Effect of repeated administration of low-dose silver nitrate for pleurodesis in a rabbit model. Respirology. 2011 Oct;16(7):1070-5. doi: 10.1111/j.1440-1843.2011.02007.x. PMID 21651643
- BACKGROUNDShaw PH, Agarwal R. WITHDRAWN: Pleurodesis for malignant pleural effusions. Cochrane Database Syst Rev. 2013 Nov 20;2013(11):CD002916. doi: 10.1002/14651858.CD002916.pub3. PMID 24259053
- BACKGROUNDArber A, Clackson C, Dargan S. Malignant pleural effusion in the palliative care setting. Int J Palliat Nurs. 2013 Jul;19(7):320, 322-5. PMID 24273808
- BACKGROUNDSuarez PM, Gilart JL. Pleurodesis in the treatment of pneumothorax and pleural effusion. Monaldi Arch Chest Dis. 2013 Jun;79(2):81-6. doi: 10.4081/monaldi.2013.96. PMID 24354096
- BACKGROUNDSchneider T, Reimer P, Storz K, Klopp M, Pfannschmidt J, Dienemann H, Hoffmann H. Recurrent pleural effusion: who benefits from a tunneled pleural catheter? Thorac Cardiovasc Surg. 2009 Feb;57(1):42-6. doi: 10.1055/s-2008-1039109. Epub 2009 Jan 23. PMID 19169996
- BACKGROUNDFerlay JSH, Bray F, Forman D, Mathers C, Parkin DM, eds. Cancer incidence and mortality worldwide [webpage]. World Health Organization, International Agency for Research on Cancer; 2008. v1.2. CancerBase No. 10. http://globocan.iarc.fr. Accessed November 11, 2011.