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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 effusion

Smarter therapeutic and diagnostic intervention in malignant pleural effusion - a feasibility randomised study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12371566
Enrollment
40
Registered
2023-10-20
Start date
2023-11-20
Completion date
Unknown
Last updated
2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant pleural effusion (MPE) Respiratory

Interventions

Eligible patients will be identified from the pleural service in each participating centre. All patients will require initial CT scan as per standard care prior to recruitment, and those with suspecte

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Feasibility of recruitment measured using patient records at end of study

Secondary

MeasureTime frame
1. Breathlessness as measured by 100mm VAS score weekly for 6 weeks post intervention (trial procedure) 2. Health Related Quality of Life (EQ-5D) weekly for 6 weeks post intervention (trial procedure) 3. Patient Anxiety and Depression (HADS) weekly for 6 weeks post intervention (trial procedure) 4. Time to actionable histopathology/diagnosis measured using patient records throughout the study 5. Healthcare utilisation measured using patient records until end of recruitment

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026