Pleural Effusion, Malignant Clinical Trial
Official title:
Clinical Efficacy and Complications of Small-bore Versus Ultra-small Bore Chest Drain in Malignant Pleural Effusion: a Randomized Clinical Trial
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.
Status | Recruiting |
Enrollment | 106 |
Est. completion date | October 30, 2025 |
Est. primary completion date | July 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Queen Mary Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
Hallifax 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. — View Citation
Havelock 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 — View Citation
Mishra 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. — View Citation
Parulekar 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. — View Citation
Rahman 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with drainage success by day 5 of chest drain | Drain success is defined by achieving nearly complete drainage through chest-x ray or ultrasound | Day 5 of chest drain insertion | |
Secondary | Pain assessed by visual analogue scale ( score from 1 to 10 )when drain is in-situ | To record pain through visual analogue scale, which in higher score signifies worse pain | Day 5 of chest drain insertion | |
Secondary | Change in dyspnea assessed by visual analogue scale for dyspnea ( score from 1 to 10 ) | To record change in dyspnea through the dyspnea visual analogue scale, which a higher score signifies worse dyspnea | Day 5 of chest drain insertion | |
Secondary | Rate of complications during and after insertion | To record and analyse complications during and after insertion | Day 5 of chest drain insertion |
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