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

Pleural Effusion, Malignant Clinical Trial

— OPTIMUM  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02517749
• Other study ID #: RJ115/N175
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: March 2020

Study information

• Verified date: November 2023
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Device:
• Chest Drain Insertion and Talc Pleurodesis

• Indwelling Pleural Catheter Insertion and Talc Pleurodesis

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	Becton, Dickinson and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global health-related quality of life	Global health related quality of life as measured by EORTC QLQ-C30	30 days
Secondary	Global health-related quality of life		60 and 90 days
Secondary	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
Secondary	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
Secondary	Complication rate	Clinical review and adverse event documentation	Day 7, 14, 30, 60 and 90