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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

Tracking Information
First Submitted Date  ICMJE August 5, 2015
First Posted Date  ICMJE August 7, 2015
Last Update Posted Date August 8, 2018
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2015)
Global health-related quality of life [ Time Frame: 30 days ]
Global health related quality of life as measured by EORTC QLQ-C30
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02517749 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2015)
  • Global health-related quality of life [ Time Frame: 60 and 90 days ]
  • 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
  • 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
  • Complication rate [ Time Frame: Day 7, 14, 30, 60 and 90 ]
    Clinical review and adverse event documentation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Out Patient Talc Slurry Via Indwelling Pleural Catheter for Malignant Pleural Effusion Vs Usual Inpatient Management
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pleural Effusion, Malignant
Intervention  ICMJE
  • Device: Chest Drain Insertion and Talc Pleurodesis
  • Device: Indwelling Pleural Catheter Insertion and Talc Pleurodesis
Study Arms  ICMJE
  • 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
    Intervention: 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
    Intervention: Device: Indwelling Pleural Catheter Insertion and Talc Pleurodesis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 5, 2015)
142
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02517749
Other Study ID Numbers  ICMJE RJ115/N175
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guy's and St Thomas' NHS Foundation Trust
Study Sponsor  ICMJE Guy's and St Thomas' NHS Foundation Trust
Collaborators  ICMJE Becton, Dickinson and Company
Investigators  ICMJE Not Provided
PRS Account Guy's and St Thomas' NHS Foundation Trust
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP