Pleurodesis in Small-bore Chest Tube

NCT07208409 | Not Yet Recruiting

• 1 other identifier: UW-24-646
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

malignant pleural effusion; pleurodesis; small bore chest tube

Outcome Measures

Primary Outcomes (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.

  1 year

Study Arms (3)

14 Fr chest tube

EXPERIMENTAL

14Fr chest tube will be inserted

Device: 14 Fr chest tube

12 Fr chest tube

ACTIVE COMPARATOR

12Fr chest tube will be inserted

Device: 12 Fr chest tube

8 Fr chest tube

ACTIVE COMPARATOR

8Fr chest tube will be inserted

Device: 8 Fr chest tube

Interventions

14 Fr chest tube DEVICE

Chest tube size of 14Fr will be inserted

14 Fr chest tube

12 Fr chest tube DEVICE

Chest tube of 12 Fr will be inserted

12 Fr chest tube

8 Fr chest tube DEVICE

Chest tube size of 8Fr will be inserted

8 Fr chest tube

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong, Queen Mary Hospital

Hong Kong, China

Location

Related Publications (4)

• 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.

  PMID: 33538338 RESULT

• 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.

  PMID: 38243259 RESULT

• 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.

  PMID: 6857580 RESULT

• 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.

  PMID: 591413 RESULT

MeSH Terms

Conditions

Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

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

Study Officials

• King Pui Florence Chan, MD

  The University of Hong Kong, Queen Mary Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

King Pui Florence Chan, MD

CONTACT

+852 22553741; kpfchan@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: October 6, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2029
• Last Updated: December 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)