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Out Patient Talc Slurry Via Indwelling Pleural Catheter for Malignant Pleural Effusion Vs Usual Inpatient Management (OPTIMUM)

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ClinicalTrials.gov Identifier: NCT02517749
Recruitment Status : Recruiting
First Posted : August 7, 2015
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
Becton, Dickinson and Company
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Study Description
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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

Condition or disease Intervention/treatment Phase
Pleural Effusion, Malignant Device: Chest Drain Insertion and Talc Pleurodesis Device: Indwelling Pleural Catheter Insertion and Talc Pleurodesis Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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
 Device: Chest Drain Insertion and Talc Pleurodesis
Active Comparator: 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
 Device: Indwelling Pleural Catheter Insertion and Talc Pleurodesis


Outcome Measures
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Primary Outcome Measures :
  1. Global health-related quality of life [ Time Frame: 30 days ]
    Global health related quality of life as measured by EORTC QLQ-C30


Secondary Outcome Measures :
  1. Global health-related quality of life [ Time Frame: 60 and 90 days ]
  2. Pleurodesis failure rate [ Time Frame: 30, 60 and 90 days ]

    Subsequent pleural intervention required on same side as pleurodesis

    Chest X-ray opacification greater than 25% on side of intervention


  3. Improvement in symptoms of pain and breathlessness [ Time Frame: 30, 60 and 90 days ]
    Medical Research Council (MRC) dyspnoea scale 100mm Visual Analog Scale for pain and breathlessness

  4. Complication rate [ Time Frame: Day 7, 14, 30, 60 and 90 ]
    Clinical review and adverse event documentation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Age less than 18 years old
  2. Pregnant or lactating
  3. Known allergy to Talc or Lignocaine
  4. Lack of symptomatic relief from effusion drainage
  5. At least twice weekly drainage cannot be undertaken

  6. Lymphoma or small cell carcinoma except*:

    1. Failure of chemotherapy
    2. Deemed for palliative management
  7. Non malignant effusions
  8. Loculated pleural effusion
  9. Unable to provide written informed consent to trial participation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02517749


Locations
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United Kingdom
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom, SE1 9RT
Contact: Joanna Peel    02071885736    joanna.peel@gstt.nhs.uk   
Principal Investigator: Liju Ahmed         
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Becton, Dickinson and Company
More Information
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02517749     History of Changes
Other Study ID Numbers: RJ115/N175
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Pleural Effusion, Malignant
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
 Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms