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

NCT04669223 | Terminated FDA Device

• 1 other identifier: UW 20-582
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pain assessed by visual analogue scale ( score from 1 to 10 )when drain is in-situ

  Day 5 of chest drain insertion

• Change in dyspnea assessed by visual analogue scale for dyspnea ( score from 1 to 10 )

  Day 5 of chest drain insertion

• Rate of complications during and after insertion

  Day 5 of chest drain insertion

Study Arms (2)

Seldinger chest drain 14F

OTHER

Patients with seldinger chest drain 14F inserted

Device: Seldinger chest drain insertion

Seldinger chest drain 8F

ACTIVE COMPARATOR

Patients with seldinger chest drain 8F inserted

Device: Seldinger chest drain insertion

Interventions

Seldinger chest drain insertion DEVICE

Different sizes of chest drain will be inserted with seldinger technique

Seldinger chest drain 14F; Seldinger chest drain 8F

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (5)

• 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.

  PMID: 20696688 BACKGROUND

• 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.

  PMID: 26720026 BACKGROUND

• 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.

  PMID: 11451810 BACKGROUND

• 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.

  PMID: 28344925 BACKGROUND

• 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.

  PMID: 25874452 BACKGROUND

MeSH Terms

Conditions

Pleural Effusion, Malignant; Lung Neoplasms

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases; Lung Diseases

Study Officials

• Mei Sze Macy Lui, MD

  Associate Consultant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 16, 2020
• Study Start: December 1, 2020
• Primary Completion: July 30, 2024
• Study Completion: October 30, 2024
• Last Updated: March 28, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)