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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 142
- Locations
- 1
- Primary Endpoint
- Global health-related quality of life
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Unable to provide written informed consent to trial participation
Arms & Interventions
Usual Care Group
Patients in this group will be managed as per the British Thoracic Society guideline for management of malignant pleural effusions. They will undergo chest tube insertion and undergo Talc pleurodesis with 4g of SteriTalc
Intervention: Chest Drain Insertion and Talc Pleurodesis (Device)
Indwelling Pleural Catheter Group
Patients in this group will undergo Indwelling Pleural Catheter (IPC) insertion. This will be inserted as per standard practice. They will undergo Talc pleurodesis via the IPC with 4g SteriTalc
Intervention: Indwelling Pleural Catheter Insertion and Talc Pleurodesis (Device)
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
- Pleurodesis failure rate(30, 60 and 90 days)
- Improvement in symptoms of pain and breathlessness(30, 60 and 90 days)
- Global health-related quality of life(60 and 90 days)
- Complication rate(Day 7, 14, 30, 60 and 90)