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CompletedNCT02517749OPTIMUMUpdated Nov 24, 2023

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

An interventional study of Chest Drain Insertion and Talc Pleurodesis and Indwelling Pleural Catheter Insertion and Talc Pleurodesis in Pleural Effusion, Malignant, sponsored by Guy's and St Thomas' NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-24.

Sponsored by Guy's and St Thomas' NHS Foundation Trust · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
142
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

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Conditions studied

  • Pleural Effusion, Malignant
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In context

Pleural Effusion, Malignant

154 studies on the registry are indexed under Pleural Effusion, Malignant; 39 are open to participants now.

This study's enrollment of 142 is above the median of 57 across 112 interventional studies indexed under Pleural Effusion, Malignant.

Browse Pleural Effusion, Malignant studies →

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 284 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
142 participants (actual)

Study arms

  • 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

Interventions

  • DeviceChest Drain Insertion and Talc Pleurodesis
  • DeviceIndwelling Pleural Catheter Insertion and Talc Pleurodesis
06

What researchers measure

Primary outcomes

  1. Global health-related quality of life

    Global health related quality of life as measured by EORTC QLQ-C30

    Time frame: 30 days

Secondary outcomes

  1. Global health-related quality of life

    Time frame: 60 and 90 days

  2. Pleurodesis failure rate

    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

  3. Improvement in symptoms of pain and breathlessness

    Medical Research Council (MRC) dyspnoea scale 100mm Visual Analog Scale for pain and breathlessness

    Time frame: 30, 60 and 90 days

  4. Complication rate

    Clinical review and adverse event documentation

    Time frame: Day 7, 14, 30, 60 and 90

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Study locations

1 site
  • Guy's and St Thomas' NHS Foundation Trust
    London, SE1 9RT, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02517749
Lead sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
Becton, Dickinson and Company
Responsible party
Sponsor
First posted
Aug 7, 2015
Start date
Aug 2015
Primary completion
Mar 2020
Completion
Mar 2020
Last update
Nov 24, 2023

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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