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

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

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

Study Overview

• Status: Unknown
• Conditions: Pleural Effusion, Malignant
• Intervention / Treatment: Device: Chest Drain Insertion and Talc Pleurodesis; Device: Indwelling Pleural Catheter Insertion and Talc Pleurodesis

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global health-related quality of life	Global health related quality of life as measured by EORTC QLQ-C30	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global health-related quality of life		60 and 90 days
Pleurodesis failure rate	Subsequent pleural intervention required on same side as pleurodesis Chest X-ray opacification greater than 25% on side of intervention	30, 60 and 90 days
Improvement in symptoms of pain and breathlessness	Medical Research Council (MRC) dyspnoea scale 100mm Visual Analog Scale for pain and breathlessness	30, 60 and 90 days
Complication rate	Clinical review and adverse event documentation	Day 7, 14, 30, 60 and 90

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: Becton, Dickinson and Company

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Anticipated): December 27, 2019
• Study Completion (Anticipated): February 27, 2020

Study Registration Dates

• First Submitted: August 5, 2015
• First Submitted That Met QC Criteria: August 5, 2015
• First Posted (Estimate): August 7, 2015

Study Record Updates

• Last Update Posted (Actual): December 12, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Effusion, Malignant; Pleural Effusion
• Other Study ID Numbers: RJ115/N175