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

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.

Study Overview

• Status: Recruiting
• Conditions: Pleural Effusion, Malignant; Lung Cancer Stage IV; Chest Tubes
• Intervention / Treatment: Device: Seldinger chest drain insertion

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.

• Study Type: Interventional
• Enrollment (Estimated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ka Yan Chiang, MBBS(HK); Phone Number: 25182111; Email: fifianchiang@gmail.com
• Study Contact Backup: Name: Mei Sze Macy Lui, MD; Phone Number: 25182111; Email: drmslui@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital
    • Contact: Ka Yan Chiang, MBBS(HK); Phone Number: 25182111; Email: fifianchiang@gmail.com
    • Sub-Investigator: Macy Mei Sze Lui, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Mei Sze Macy Lui, MD, Associate Consultant

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 13, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Effusion, Malignant; Pleural Effusion
• Other Study ID Numbers: UW 20-582

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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