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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomised Controlled Trial Comparing Outpatient Management of Malignant Pleural Effusion Via an Indwelling Pleural Catheter and Talc Pleurodesis Versus Standard Inpatient

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 Summary:
Sponsor: Guy's and St Thomas' NHS Foundation Trust

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Guy's and St Thomas' NHS Foundation Trust

Dates:
Date Received: August 5, 2015
Date Started: August 2015
Date Completion: January 2020
Last Updated: September 19, 2016
Last Verified: September 2016