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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04669223
Other study ID # UW 20-582
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date October 30, 2025

Study information

Verified date November 2023
Source The University of Hong Kong
Contact Ka Yan Chiang, MBBS(HK)
Phone 25182111
Email fifianchiang@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Introduction: Malignant pleural effusion (MPE) is the commonest complication of lung cancer, and its associated symptoms are frequent causes of hospitalizations and morbidities in patients with disseminated cancers. Chest tube drainage is often performed for symptomatic relief. Recent clinical trials had shown that large-bore chest drains (>14 French) caused significantly more pain than smaller drain during the insertion procedure and when the drain was in situ, which prompts the shift of preference towards smaller chest drains in guideline and clinical practice. Chest drains as small-bore as 7-8 French have been used in many local centers for drainage of MPE, though little attention has been made to the possible higher occurrence of drain blockage, kinking or dislodgement before optimal effusion drainage is achieved, which may lead to a second procedure for drain replacement. Currently, there is no data informing the efficacy and complications of ultra-small chest drains in clinical use. Therefore, it is imperative to call for further research on the optimal size of the chest drain which can achieve satisfactory drainage and at the same time, of minimal complications. Study design: Single-center, parallel group, single blinded, randomized controlled study Study site: Department of Medicine, Queen Mary Hospital Target study participants: Subjects with symptomatic MPE requiring chest drainage Method and analysis: This randomized controlled study to compare the efficacy of ultra-small bore chest drains (8 Fr) with standard small bore chest drain (14 French) as the reference. Primary outcome is drain success defined by nearly complete drainage of MPE on chest radiograph on day 5 of the drain. Other secondary outcomes include pain according to the visual analogue scale, dyspnea relief and complications during the procedure and post - chest drain insertion.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
Seldinger chest drain insertion
Different sizes of chest drain will be inserted with seldinger technique

Locations

Country Name City State
Hong Kong Queen Mary Hospital Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (5)

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

Outcome

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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