Clinical trial · Interventional
Rapid Pleurodesis Through an Indwelling Pleural Catheter
A Randomized, Double Blinded, Controlled Trial of a Rapid Pleurodesis Protocol After Indwelling Pleural Catheter Placement for Malignant Pleural Effusions
NCT03325192CI-TRIAL-00045009RAPIDterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow enrollment
Summary
Brief summary (as posted)
The primary objective of the study is to evaluate whether the use of a rapid pleurodesis protocol using 10% iodopovidone immediately after tunneled pleural catheter placement improves time to IPC removal compared to patients who receive an IPC alone.
Conditions
Conditions (3)
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 Diseases | — | UNRESOLVED | — |
| Pleural Effusion, Malignant | — | UNRESOLVED | — |
| Pleurodesis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| Rapid pleurodesis protocol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Standard of care
- description
- Subjects in this arm will receive placebo only (100mL of normal saline) into the pleural space delivered via the newly placed tunneled intrapleural catheter
- interventionNames
- Other: Placebo
- type
- EXPERIMENTAL
- label
- Rapid pleurodesis protocol
- description
- Subjects in this arm will receive the chemical pleurodesing agent of 10% iodopovidone solution delivered to the pleural space via the newly placed tunneled intrapleural catheter
- interventionNames
- Drug: Rapid pleurodesis protocol
Primary outcomes (1)
- measure
- Time to catheter removal
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of MPE as defined by 1. A diagnosis a pleural effusion in the setting of known malignancy. AND 2. Confirmed malignant involvement of the pleural space by fluid cytology or pleural biopsy. OR 3. Evidence of pleural disease on radiographic imaging. OR 4. A recurrent effusion with no other identifiable cause after thorough workup. 2. Symptomatic from the pleural effusions (shortness of breath, cough, or chest pain) 3. Prior thoracentesis with post procedure symptomatic relief 4. Recurrence of symptoms with re-accumulation of pleural effusion 5. Lung re-expansion after thoracentesis on chest imaging within last 30 days Exclusion Criteria: 1. Malignant pleural effusion due to a hematologic malignancy 2. ECOG \>4 3. Any history of trapped lung 4. Prior attempted pleurodesis on the affected site 5. Age \<18 6. Pregnant or lactating 7. Known allergy to iodopovidone (Betadine) 8. Unable or unwilling to provide consent 9. Uncorrectable coagulopathy (INR \> 1.5, aPTT \> 1.5 x the upper limit of normal) or thrombocytopenia (\< 50,000) 10. Anatomic contraindication to IPC (overlying skin abnormalities) 11. Unable or unwilling to care for IPC and adhere to drainage protocol 12. Need for bilateral IPC placement
References
Publications (17)
- BACKGROUNDAntunes G, Neville E, Duffy J, Ali N; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the management of malignant pleural effusions. Thorax. 2003 May;58 Suppl 2(Suppl 2):ii29-38. doi: 10.1136/thorax.58.suppl_2.ii29. No abstract available. PMID 12728148
- BACKGROUNDAmerican Thoracic Society. Management of malignant pleural effusions. Am J Respir Crit Care Med. 2000 Nov;162(5):1987-2001. doi: 10.1164/ajrccm.162.5.ats8-00. No abstract available. PMID 11069845
- BACKGROUNDDavies HE, Mishra EK, Kahan BC, Wrightson JM, Stanton AE, Guhan A, Davies CW, Grayez J, Harrison R, Prasad A, Crosthwaite N, Lee YC, Davies RJ, Miller RF, Rahman NM. Effect of an indwelling pleural catheter vs chest tube and talc pleurodesis for relieving dyspnea in patients with malignant pleural effusion: the TIME2 randomized controlled trial. JAMA. 2012 Jun 13;307(22):2383-9. doi: 10.1001/jama.2012.5535. PMID 22610520
- 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
- BACKGROUNDWahidi MM, Reddy C, Yarmus L, Feller-Kopman D, Musani A, Shepherd RW, Lee H, Bechara R, Lamb C, Shofer S, Mahmood K, Michaud G, Puchalski J, Rafeq S, Cattaneo SM, Mullon J, Leh S, Mayse M, Thomas SM, Peterson B, Light RW. Randomized Trial of Pleural Fluid Drainage Frequency in Patients with Malignant Pleural Effusions. The ASAP Trial. Am J Respir Crit Care Med. 2017 Apr 15;195(8):1050-1057. doi: 10.1164/rccm.201607-1404OC. PMID 27898215
- BACKGROUNDLui MM, Thomas R, Lee YC. Complications of indwelling pleural catheter use and their management. BMJ Open Respir Res. 2016 Feb 5;3(1):e000123. doi: 10.1136/bmjresp-2015-000123. eCollection 2016.