Comparing Different Sizes of Small-bore Chest Drains in Malignant Pleural Effusion
Primary Purpose
Pleural Effusion, Malignant, Lung Cancer Stage IV, Chest Tubes
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Seldinger chest drain insertion
Sponsored by
About this trial
This is an interventional treatment trial for Pleural Effusion, Malignant
Eligibility Criteria
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
Sites / Locations
- Queen Mary HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Seldinger chest drain 14F
Seldinger chest drain 8F
Arm Description
Patients with seldinger chest drain 14F inserted
Patients with seldinger chest drain 8F inserted
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Rate of complications during and after insertion
To record and analyse complications during and after insertion
Full Information
NCT ID
NCT04669223
First Posted
December 1, 2020
Last Updated
May 16, 2022
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04669223
Brief Title
Comparing Different Sizes of Small-bore Chest Drains in Malignant Pleural Effusion
Official Title
Clinical Efficacy and Complications of Small-bore Versus Ultra-small Bore Chest Drain in Malignant Pleural Effusion: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
July 30, 2025 (Anticipated)
Study Completion Date
October 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion, Malignant, Lung Cancer Stage IV, Chest Tubes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Seldinger chest drain 14F
Arm Type
Other
Arm Description
Patients with seldinger chest drain 14F inserted
Arm Title
Seldinger chest drain 8F
Arm Type
Active Comparator
Arm Description
Patients with seldinger chest drain 8F inserted
Intervention Type
Device
Intervention Name(s)
Seldinger chest drain insertion
Intervention Description
Different sizes of chest drain will be inserted with seldinger technique
Primary Outcome Measure Information:
Title
Number of patients with drainage success by day 5 of chest drain
Description
Drain success is defined by achieving nearly complete drainage through chest-x ray or ultrasound
Time Frame
Day 5 of chest drain insertion
Secondary Outcome Measure Information:
Title
Pain assessed by visual analogue scale ( score from 1 to 10 )when drain is in-situ
Description
To record pain through visual analogue scale, which in higher score signifies worse pain
Time Frame
Day 5 of chest drain insertion
Title
Change in dyspnea assessed by visual analogue scale for dyspnea ( score from 1 to 10 )
Description
To record change in dyspnea through the dyspnea visual analogue scale, which a higher score signifies worse dyspnea
Time Frame
Day 5 of chest drain insertion
Title
Rate of complications during and after insertion
Description
To record and analyse complications during and after insertion
Time Frame
Day 5 of chest drain insertion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ka Yan Chiang, MBBS(HK)
Phone
25182111
Email
fifianchiang@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mei Sze Macy Lui, MD
Phone
25182111
Email
drmslui@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei Sze Macy Lui, MD
Organizational Affiliation
Associate Consultant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ka Yan Chiang, MBBS(HK)
Phone
25182111
Email
fifianchiang@gmail.com
First Name & Middle Initial & Last Name & Degree
Macy Mei Sze Lui, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20696688
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 available.
Results Reference
result
PubMed Identifier
26720026
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, 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. Erratum In: JAMA. 2016 Feb 16;315(7):707. JAMA. 2016 Apr 19;315(15):1661.
Results Reference
result
PubMed Identifier
11451810
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.
Results Reference
result
PubMed Identifier
28344925
Citation
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.
Results Reference
result
PubMed Identifier
25874452
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: 10.1371/journal.pone.0123798. eCollection 2015.
Results Reference
result
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Comparing Different Sizes of Small-bore Chest Drains in Malignant Pleural Effusion
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