Back to resultsOut Patient Talc Slurry Via Indwelling Pleural Catheter for Malignant Pleural Effusion Vs Usual Inpatient Management (OPTIMUM)
Primary Purpose
Pleural Effusion, Malignant
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Chest Drain Insertion and Talc Pleurodesis
Indwelling Pleural Catheter Insertion and Talc Pleurodesis
Sponsored by
About this trial
This is an interventional treatment trial for Pleural Effusion, Malignant
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
- Unable to provide written informed consent to trial participation
Sites / Locations
- Guy's and St Thomas' NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Usual Care Group
Indwelling Pleural Catheter Group
Arm Description
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
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
Outcomes
Primary Outcome Measures
Global health-related quality of life
Global health related quality of life as measured by EORTC QLQ-C30
Secondary Outcome Measures
Global health-related quality of life
Pleurodesis failure rate
Subsequent pleural intervention required on same side as pleurodesis
Chest X-ray opacification greater than 25% on side of intervention
Improvement in symptoms of pain and breathlessness
Medical Research Council (MRC) dyspnoea scale 100mm Visual Analog Scale for pain and breathlessness
Complication rate
Clinical review and adverse event documentation
Full Information
NCT ID
NCT02517749
First Posted
August 5, 2015
Last Updated
December 10, 2019
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
Becton, Dickinson and Company
1. Study Identification
Unique Protocol Identification Number
NCT02517749
Brief Title
Out Patient Talc Slurry Via Indwelling Pleural Catheter for Malignant Pleural Effusion Vs Usual Inpatient Management
Acronym
OPTIMUM
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (Actual)
Primary Completion Date
December 27, 2019 (Anticipated)
Study Completion Date
February 27, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
Becton, Dickinson and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion, Malignant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Indwelling Pleural Catheter Group
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Chest Drain Insertion and Talc Pleurodesis
Intervention Type
Device
Intervention Name(s)
Indwelling Pleural Catheter Insertion and Talc Pleurodesis
Primary Outcome Measure Information:
Title
Global health-related quality of life
Description
Global health related quality of life as measured by EORTC QLQ-C30
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Global health-related quality of life
Time Frame
60 and 90 days
Title
Pleurodesis failure rate
Description
Subsequent pleural intervention required on same side as pleurodesis
Chest X-ray opacification greater than 25% on side of intervention
Time Frame
30, 60 and 90 days
Title
Improvement in symptoms of pain and breathlessness
Description
Medical Research Council (MRC) dyspnoea scale 100mm Visual Analog Scale for pain and breathlessness
Time Frame
30, 60 and 90 days
Title
Complication rate
Description
Clinical review and adverse event documentation
Time Frame
Day 7, 14, 30, 60 and 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Unable to provide written informed consent to trial participation
Facility Information:
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Out Patient Talc Slurry Via Indwelling Pleural Catheter for Malignant Pleural Effusion Vs Usual Inpatient Management
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