Out Patient Talc Slurry Via Indwelling Pleural Catheter for Malignant Pleural Effusion Vs Usual Inpatient Management
OPTIMUM
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
1 other identifier
interventional
142
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 5, 2015
CompletedFirst Posted
Study publicly available on registry
August 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedNovember 24, 2023
November 1, 2023
4.6 years
August 5, 2015
November 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Global health-related quality of life
Global health related quality of life as measured by EORTC QLQ-C30
30 days
Secondary Outcomes (4)
Global health-related quality of life
60 and 90 days
Pleurodesis failure rate
30, 60 and 90 days
Improvement in symptoms of pain and breathlessness
30, 60 and 90 days
Complication rate
Day 7, 14, 30, 60 and 90
Study Arms (2)
Usual Care Group
ACTIVE COMPARATORPatients 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
Indwelling Pleural Catheter Group
ACTIVE COMPARATORPatients 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2015
First Posted
August 7, 2015
Study Start
August 1, 2015
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
November 24, 2023
Record last verified: 2023-11