Clinical trial · Interventional
Pleurodesis in Small-bore Chest Tube
How Small Is Small - Pleurodesis in Small-Bore Chest Tube
- 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) imposes a high burden on the healthcare system in the Asian Pacific region, as lung and breast cancer are the commonest cancers associated with malignant pleural effusion, as the two commonest cancers in the Asian Pacific region. While indwelling pleural catheter (IPC), a catheter that is inserted for long-term drainage of pleural fluid, is not commonly used in Asian countries, small-bore chest tubes are increasingly used due to their ease of insertion and causing less pain. Injecting talc, a chemocal, to promote adhesion of pleura, called talc pleurodesis was an effective method of managing MPE. However, the optimal size of small-bore chest tubes and the feasibility of talc pleurodesis have not been thoroughly investigated. This randomised controlled trial aims to evaluate the feasibility and success rate of pleurodesis using small-bore chest drains and to examine the outcomes associated with different sizes of these drains, namely 8 Fr, 12 Fr, and 14 Fr, in managing MPE. The primary outcome is the feasibility of talc pleurodesis with different small-bore chest tubes. Secondary outcomes include the differences in recurrence rates post-pleurodesis between small-bore and ultra-small-bore chest tubes, as well as patient outcomes such as pain scores, SpO2/FiO2 ratios (oxygen saturation/fractional inspired oxygen ratio), and complications. The sample size will be 60, and the project will be carried out over one year. The outcome of this study can serve as a reference for managing MPE regarding the feasibility, safety, and efficacy of ultra-small-bore chest tubes worldwide, particularly in the Asia-Pacific region, where IPC is less common.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 12 Fr chest tube | Device | — | UNRESOLVED |
| 14 Fr chest tube | Device | — | UNRESOLVED |
| 8 Fr chest tube | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 14 Fr chest tube
- description
- 14Fr chest tube will be inserted
- interventionNames
- Device: 14 Fr chest tube
- type
- ACTIVE_COMPARATOR
- label
- 12 Fr chest tube
- description
- 12Fr chest tube will be inserted
- interventionNames
- Device: 12 Fr chest tube
- type
- ACTIVE_COMPARATOR
- label
- 8 Fr chest tube
- description
- 8Fr chest tube will be inserted
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pleural effusion. * With clinical indications for pleural drainage and chest drain insertion. * With anticipated need for pleurodesis e.g. known malignancy, no clinical signs of pleural infection. * age ≥18 year-old Exclusion Criteria: * Pleural effusion not sizable for drainage. * With clinical suspicion of pleural infection e.g. pleuritic chest pain, fever, ultrasound showed loculated pleural effusion * Age ≤18 year-old
References
Publications (4)
- RESULTSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- RESULTGonnelli F, Hassan W, Bonifazi M, Pinelli V, Bedawi EO, Porcel JM, Rahman NM, Mei F. Malignant pleural effusion: current understanding and therapeutic approach. Respir Res. 2024 Jan 19;25(1):47. doi: 10.1186/s12931-024-02684-7. PMID 38243259
- RESULTKreisman H, Wolkove N, Finkelstein HS, Cohen C, Margolese R, Frank H. Breast cancer and thoracic metastases: review of 119 patients. Thorax. 1983 Mar;38(3):175-9. doi: 10.1136/thx.38.3.175. PMID 6857580
- RESULTWeichselbaum R, Marck A, Hellman S. Pathogenesis of pleural effusion in carcinoma of the breast. Int J Radiat Oncol Biol Phys. 1977 Sep-Oct;2(9-10):963-5. doi: 10.1016/0360-3016(77)90195-x. No abstract available. PMID 591413