Pleurodesis in Small-bore Chest Tube
ConditionPleural Effusion, Malignant
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
14 Fr chest tube
DeviceChest tube size of 14Fr will be inserted
12 Fr chest tube
DeviceChest tube of 12 Fr will be inserted
8 Fr chest tube
DeviceChest tube size of 8Fr will be inserted
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: 14 Fr chest tubeExperimental treatment 1 intervention
Group B: 12 Fr chest tubeActive comparator 1 intervention
Group C: 8 Fr chest tubeActive comparator 1 intervention
Trial outcomes
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.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: