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Completed

NCT Number: NCT02517749

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

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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Key information

Conditions

Pleural Effusion, Malignant Neoplasms Neoplasms by Site Pleural Diseases Pleural Effusion Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chest Drain Insertion and Talc Pleurodesis

Device

Indwelling Pleural Catheter Insertion and Talc Pleurodesis

Device

Primary outcomes

  1. Global health-related quality of life

    Time frame: 30 days

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Collaborators

  • Becton, Dickinson and Company

Registry information

Official study 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

Acronym: OPTIMUM

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Aug 7, 2015
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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