Clinical trial · Interventional
Comparing Different Sizes of Small-bore Chest Drains in Malignant Pleural Effusion
Clinical Efficacy and Complications of Small-bore Versus Ultra-small Bore Chest Drain in Malignant Pleural Effusion: a Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): difficult recruitment encountered during pandemic
Summary
Brief summary (as posted)
Malignant pleural effusion (MPE) is a very common medical condition, especially among patients with disseminated cancers. Chest drain insertion aims to drain the pleural fluid collection and relieve dyspnea. Small bore chest tubes are recommended as the first line therapy for draining pleural effusions. However, there is no clinical data available to inform on the size of drains for better drainage. This is a randomized study comparing the two common bores of small bore chest drains in Hong Kong, and assess for its clinical efficacy and complication risks.
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 |
|---|---|---|---|
| Chest Tubes | — | UNRESOLVED | — |
| Lung Cancer Stage IV | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Pleural Effusion, Malignant | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Seldinger chest drain insertion | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Seldinger chest drain 14F
- description
- Patients with seldinger chest drain 14F inserted
- interventionNames
- Device: Seldinger chest drain insertion
- type
- ACTIVE_COMPARATOR
- label
- Seldinger chest drain 8F
- description
- Patients with seldinger chest drain 8F inserted
- interventionNames
- Device: Seldinger chest drain insertion
Primary outcomes (1)
- measure
- Number of patients with drainage success by day 5 of chest drain
- timeFrame
- Day 5 of chest drain insertion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have cytologically/histologically proven pleural malignancy, or who have pleural effusion in the context of malignancy elsewhere * The pleural effusion is at least moderate to massive and causes symptoms * Ability to give informed written consent to the study Exclusion Criteria: * Age \<18 years old * Bleeding tendency not readily correctable (platelet \< 100 x 10\^9, INR ≥1.5 after transfusion) * Hydropneumothorax before drain insertion * Moderate-heavy septations in the pleural effusion (defined as a collection with more than 4 septations visible at the maximally septated area) * Clinical emergency that an urgent chest drain is required * Allergy to local anesthesia agents * Blindness * History of pleurodesis on the same side of malignant pleural effusion requiring drainage
References
Publications (5)
- RESULTHavelock T, Teoh R, Laws D, Gleeson F; BTS Pleural Disease Guideline Group. Pleural procedures and thoracic ultrasound: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii61-76. doi: 10.1136/thx.2010.137026. No abstract available. PMID 20696688
- RESULTRahman NM, Pepperell J, Rehal S, Saba T, Tang A, Ali N, West A, Hettiarachchi G, Mukherjee D, Samuel J, Bentley A, Dowson L, Miles J, Ryan CF, Yoneda KY, Chauhan A, Corcoran JP, Psallidas I, Wrightson JM, Hallifax R, Davies HE, Lee YC, Dobson M, Hedley EL, Seaton D, Russell N, Chapman M, McFadyen BM, Shaw RA, Davies RJ, Maskell NA, Nunn AJ, Miller RF. Effect of Opioids vs NSAIDs and Larger vs Smaller Chest Tube Size on Pain Control and Pleurodesis Efficacy Among Patients With Malignant Pleural Effusion: The TIME1 Randomized Clinical Trial. JAMA. 2015 Dec 22-29;314(24):2641-53. doi: 10.1001/jama.2015.16840. PMID 26720026
- RESULTParulekar W, Di Primio G, Matzinger F, Dennie C, Bociek G. Use of small-bore vs large-bore chest tubes for treatment of malignant pleural effusions. Chest. 2001 Jul;120(1):19-25. doi: 10.1378/chest.120.1.19. PMID 11451810
- RESULTHallifax RJ, Psallidas I, Rahman NM. Chest Drain Size: the Debate Continues. Curr Pulmonol Rep. 2017;6(1):26-29. doi: 10.1007/s13665-017-0162-3. Epub 2017 Jan 26. PMID 28344925
- RESULTMishra EK, Corcoran JP, Hallifax RJ, Stradling J, Maskell NA, Rahman NM. Defining the minimal important difference for the visual analogue scale assessing dyspnea in patients with malignant pleural effusions. PLoS One. 2015 Apr 15;10(4):e0123798. doi: 10.1371/journal.pone.0123798. eCollection 2015. PMID 25874452