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Pleural Effusion, MalignantNCT07208409

Pleurodesis in Small-bore Chest Tube

A study testing 14 Fr chest tube, 12 Fr chest tube and 8 Fr chest tube in people with Pleural Effusion, Malignant, run by The University of Hong Kong at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pleural Effusion, Malignant
What is being tested?
14 Fr chest tube, 12 Fr chest tube and 8 Fr chest tube
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
1 Feb 2026to 31 Jan 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pleural effusion.
  • With clinical indications for pleural drainage and chest drain insertion.
  • With anticipated need for pleurodesis e.g. known malignancy, no clinical signs of pleural infection.
  • age ≥18 year-old

Who cannot join

  • Pleural effusion not sizable for drainage.
  • With clinical suspicion of pleural infection e.g. pleuritic chest pain, fever, ultrasound showed loculated pleural effusion
  • Age ≤18 year-old

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

King Pui Florence Chan, MD contact

+852 22553741

kpfchan@hku.hk

China1 site
  • The University of Hong Kong, Queen Mary Hospital

    Hong Kong

    King-Pui Florence Chan, MD, 825 2255 3741, kpfchan@hku.hk

Other trials in China

About this study

Official title: How Small Is Small - Pleurodesis in Small-Bore Chest Tube

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.

Read more

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.

Read the detailed description

Chest tubes can be classified as large bore or small-bore base on the size, with commonly ≤14 French (Fr) was defined as small-bore and >14 Fr was defined as large bore. Small-bore chest tubes are increasingly used in malignant pleural effusion (MPE) since it is easier to insert and was reported to have less pain while insertion and in place. However, there is limited evidence and guideline on the use of small-bore chest tube. The size of chest tube for optimal drainage was not mentioned in the British Thoracic Society (BTS) guideline for pleural disease.

Pleurodesis is indicated for MPE or secondary pneumothorax to reduce the recurrent way, and can be performed in surgical or chemical. Different agents are available for chemical pleurodesis, namely talc, minocycline or blood patch. For MPE, talc slurry was shown to be non-inferior than talc poudrage for pleurodesis successful rate, and was shown to be superior than other sclerosant in chemical pleurodesis. For secondary spontaneous pneumothorax, chemical pleurodesis is performed when patient is not a surgical candidate or according to patient's preference. Chemical pleurodesis with talc slurry was shown to have higher efficacy and lower recurrence rate of pneumothorax compared with doxycycline in Asian population.

From the BTS clinical statement on pleural procedures, meta-analyses of studies on different chest tube size for pleurodesis show similar risks of procedure failure with large and small-bore tubes. However, limited evidence was available. The only randomised control trial with adequate sample size found small-bore chest tube was non inferior to large bore chest tube in terms of pleurodesis efficacy. There was a report of use of small-bore chest tube with size 10Fr in MPE, showing response rate of 84.2% post pleurodesis.

The definition of pleurodesis failure in MPE varies. Definition commonly used in previous studies define pleurodesis failure as pleural fluid recurrence in ipsilateral hemithorax requiring further therapeutic pleural intervention, with radiological evidence including chest x-ray (CXR), computed tomography (CT) scan of thorax or transthoracic ultrasound demonstrated same fluid recurrence upon follow up. Partial response was defined as localise effusion that does not progress, cause symptoms or require drainage.

In current practice for chest tube insertion by respiratory team in Queen Mary Hospital, chest tubes with pigtail or seldinger technique are available in size of 8Fr, 12Fr, 14Fr and 18Fr for drainage of pleural effusion or pneumothorax. Pleurodesis, commonly by talc, is performed through chest tubes when clinically indicated.

In this study, we hypothesize that the use of small bore and ultra small bore chest tubes are both effective in managing pleural effusion.

This is a prospective randomised controlled study for patients with MPE who require chest tube insertion. Eligible patients will be randomised into 1:1:1 ratio on 8Fr, 12 Fr or 14 Fr size chest tube. The study will be conducted at Queen Mary Hospital, a tertiary and university-affiliated hospital in Hong Kong.

After study recruitment, chest drain with size according to randomization will be inserted. The baseline characteristics, namely age, sex, underlying malignancy, size of pleural effusion, the patient outcomes including pain score, oxygen saturation, complications including dislodgement, infection, hemothorax, blocked tube and mortality will be analysed between different groups.

For statistical analysis, univariant analysis will be performed first. For categorical factors, including recurrence of pleural effusion or pneumothorax in different groups, Fisher exact test will be performed. Odd ratios will be calculated. Unpaired data on two samples will be performed by Wilcoxon rank sum test. Multivariant logistic regression will then be performed on the effect of different factors on the outcomes. P < 0.05 was taken as statistically significant.

Being tested
14 Fr chest tube, 12 Fr chest tube, 8 Fr chest tube
Keywords
malignant pleural effusion, pleurodesis, small bore chest tube
Medical subject headings
Pleural Effusion, Malignant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 14 Fr chest tubeDevice

    Chest tube size of 14Fr will be inserted

  • 12 Fr chest tubeDevice

    Chest tube of 12 Fr will be inserted

  • 8 Fr chest tubeDevice

    Chest tube size of 8Fr will be inserted

Study groups in NCT07208409
Study groupRoleWhat they receive
14 Fr chest tubeExperimental14Fr chest tube will be inserted
Receives: Device: 14 Fr chest tube
12 Fr chest tubeActive comparator12Fr chest tube will be inserted
Receives: Device: 12 Fr chest tube
8 Fr chest tubeActive comparator8Fr chest tube will be inserted
Receives: Device: 8 Fr chest tube

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with functional chest tubes after talc pleurodesis in each group

    Drainage tube blockage was one of the most common complications for small bore chest tube drainage. While small-bore chest tubes were reported to have similar efficiency for talc pleurodesis, the feasibility of different sizes of small-bore chest tubes i.e. functional chest tubes after talc pleurodesis was not investigated. There is no randomised controlled trial of the feasibility of 8Fr chest tubes compared to other sizes ≤14 Fr. Number of patients with functional chest tube after talc pleurodesis in each group, defined as the chest tube able to drain fluid and air after talc pleurodesis, i.e. not obstructed, is the primary outcome of this study.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2025
  2. Study start1 Feb 2026 (estimated)
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07208409
Sponsor's protocol ID
UW-24-646
Status last verified
Aug 2025
First submitted
27 Aug 2025
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: According to the current ethics approval protocol, the IPD will be stored anonymously and destroyed 3 years after completion of study.

Publications

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338
  • Gonnelli F, Hassan W, Bonifazi M, Pinelli V, Bedawi EO, Porcel JM, Rahman NM, Mei F. Malignant pleural effusion: current understanding and therapeutic approach. Respir Res. 2024 Jan 19;25(1):47. doi: 10.1186/s12931-024-02684-7.

    PubMed 38243259
  • Kreisman H, Wolkove N, Finkelstein HS, Cohen C, Margolese R, Frank H. Breast cancer and thoracic metastases: review of 119 patients. Thorax. 1983 Mar;38(3):175-9. doi: 10.1136/thx.38.3.175.

    PubMed 6857580
  • Weichselbaum R, Marck A, Hellman S. Pathogenesis of pleural effusion in carcinoma of the breast. Int J Radiat Oncol Biol Phys. 1977 Sep-Oct;2(9-10):963-5. doi: 10.1016/0360-3016(77)90195-x. No abstract available.

    PubMed 591413

Questions about this trial

What is this clinical trial studying?

A study testing 14 Fr chest tube, 12 Fr chest tube and 8 Fr chest tube in people with Pleural Effusion, Malignant, run by The University of Hong Kong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact King Pui Florence Chan, MD (+852 22553741, kpfchan@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with functional chest tubes after talc pleurodesis in each group (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07208409, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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