Comparing Different Sizes of Small-bore Chest Drains in Malignant Pleural Effusion

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Efficacy and Complications of Small-bore Versus Ultra-small Bore Chest Drain in Malignant Pleural Effusion: a Randomized Clinical Trial

Conditions
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Pleural Effusion, Malignant, Lung Cancer Stage IV, Chest Tubes

Intervention / Treatment
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* Device: Seldinger chest drain insertion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Seldinger chest drain 14F<br>Patients with seldinger chest drain 14F inserted | Device: Seldinger chest drain insertion<br>* Different sizes of chest drain will be inserted with seldinger technique<br>|
| Active Comparator: Seldinger chest drain 8F<br>Patients with seldinger chest drain 8F inserted | Device: Seldinger chest drain insertion<br>* Different sizes of chest drain will be inserted with seldinger technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Rate of complications during and after insertion | To record and analyse complications during and after insertion | Day 5 of chest drain insertion |