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Clinical Trials/ISRCTN12371566
ISRCTN12371566
Active, not recruiting
未知

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

niversity of Oxford0 sites40 target enrollmentOctober 20, 2023

Overview

Phase
未知
Intervention
Not specified
Conditions
Malignant pleural effusion (MPE)
Sponsor
niversity of Oxford
Enrollment
40
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 20, 2023
End Date
January 2, 2026
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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