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Clinical Trials/NCT02517749
NCT02517749
Completed
N/A

Randomised Controlled Trial Comparing Outpatient Management of Malignant Pleural Effusion Via an Indwelling Pleural Catheter and Talc Pleurodesis Versus Standard Inpatient Management in Improving Health Related Quality of Life

Guy's and St Thomas' NHS Foundation Trust1 site in 1 country142 target enrollmentAugust 2015
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ConditionsPleural Effusion, Malignant

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pleural Effusion, Malignant
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Enrollment
142
Locations
1
Primary Endpoint
Global health-related quality of life
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This is a multicentre randomised controlled trial evaluating global health related quality of life outcomes in patients with malignant pleural effusions. Patients will be randomised to receive either chest drain and talc pleurodesis or indwelling pleural catheter and talc pleurodesis. Patients will be followed up for 3 months post intervention

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
March 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Diagnosis of malignant pleural effusion
  • •WHO performance status 2 or less unless performance status is impaired by presence of effusion and likely to significantly improve with drainage
  • •Expected survival greater than 3 months

Exclusion Criteria

  • •Age less than 18 years old
  • •Pregnant or lactating
  • •Known allergy to Talc or Lignocaine
  • •Lack of symptomatic relief from effusion drainage
  • •At least twice weekly drainage cannot be undertaken
  • •Lymphoma or small cell carcinoma except\*:
  • •Failure of chemotherapy
  • •Deemed for palliative management
  • •Non malignant effusions
  • •Loculated pleural effusion

Outcomes

Primary Outcomes

Global health-related quality of life

Time Frame: 30 days

Global health related quality of life as measured by EORTC QLQ-C30

Secondary Outcomes

  • Global health-related quality of life(60 and 90 days)
  • Complication rate(Day 7, 14, 30, 60 and 90)
  • Pleurodesis failure rate(30, 60 and 90 days)
  • Improvement in symptoms of pain and breathlessness(30, 60 and 90 days)

Study Sites (1)

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