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Pleurodesis in Small-bore Chest Tube

NCT07208409 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-24

No results posted yet for this study

Summary

Malignant pleural effusion (MPE) imposes a high burden on the healthcare system in the Asian Pacific region, as lung and breast cancer are the commonest cancers associated with malignant pleural effusion, as the two commonest cancers in the Asian Pacific region.

While indwelling pleural catheter (IPC), a catheter that is inserted for long-term drainage of pleural fluid, is not commonly used in Asian countries, small-bore chest tubes are increasingly used due to their ease of insertion and causing less pain.

Injecting talc, a chemocal, to promote adhesion of pleura, called talc pleurodesis was an effective method of managing MPE. However, the optimal size of small-bore chest tubes and the feasibility of talc pleurodesis have not been thoroughly investigated.

This randomised controlled trial aims to evaluate the feasibility and success rate of pleurodesis using small-bore chest drains and to examine the outcomes associated with different sizes of these drains, namely 8 Fr, 12 Fr, and 14 Fr, in managing MPE.

The primary outcome is the feasibility of talc pleurodesis with different small-bore chest tubes. Secondary outcomes include the differences in recurrence rates post-pleurodesis between small-bore and ultra-small-bore chest tubes, as well as patient outcomes such as pain scores, SpO2/FiO2 ratios (oxygen saturation/fractional inspired oxygen ratio), and complications.

The sample size will be 60, and the project will be carried out over one year.

The outcome of this study can serve as a reference for managing MPE regarding the feasibility, safety, and efficacy of ultra-small-bore chest tubes worldwide, particularly in the Asia-Pacific region, where IPC is less common.

Conditions

  • Pleural Effusion, Malignant

Interventions

DEVICE

14 Fr chest tube

Chest tube size of 14Fr will be inserted

DEVICE

12 Fr chest tube

Chest tube of 12 Fr will be inserted

DEVICE

8 Fr chest tube

Chest tube size of 8Fr will be inserted

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • King Pui Florence Chan, MD · The University of Hong Kong, Queen Mary Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2027-01-31
Completion
2029-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07208409 on ClinicalTrials.gov