A randomised study to assess the feasibility of pleural biopsy and indwelling pleural catheter insertion as a first procedure versus pleural aspiration in suspected malignant pleural effusio
- Conditions
- Malignant pleural effusion (MPE)Respiratory
- Registration Number
- ISRCTN12371566
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 40
1. Symptomatic unilateral (or bilateral if one side dominates) pleural effusion AND any of the following*
1.1. Suspicion of malignant cause based on imaging features on CT or ultrasound
1.2. Previous proven diagnosis of extrapleural malignancy
1.3. Lack of alternative likely clinical diagnosis such as infection or heart failure (as judged by local PI)
2. Sufficient pleural effusion size as determined on ultrasound to require therapeutic pleural drainage
3. Participant is willing and able to give informed consent for participation in the trial.
4. Male or Female, aged 18 years or above.
*The above features will be assessed by the local recruiting clinician, and judgments on likely clinical diagnosis and the imaging features will be conducted by local recruiting clinicians to remain pragmatic.
1. Technically unable to undergo pleural biopsy and indwelling pleural catheter (e.g. gross respiratory failure, uncorrectable clotting, unable to tolerate position, poor performance status (WHO performance status 3 or worse when accounting for the effusion)).
2. Visual impairment (precluding use of symptom measurement instruments
3. Previous talc pleurodesis within the last 3 months on ipsilateral side.
4. No means of phone contact
5. Age < 18 years
6. Females who are pregnant or lactating
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method