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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02517749

Acronym

OPTIMUM

Enrollment

142

Registered

2015-08-07

Start date

2015-08-31

Completion date

2020-03-31

Last updated

2023-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleural Effusion, Malignant

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

Interventions

DEVICEChest Drain Insertion and Talc Pleurodesis

DEVICEIndwelling Pleural Catheter Insertion and Talc Pleurodesis

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Global health-related quality of life	60 and 90 days	—
Pleurodesis failure rate	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	30, 60 and 90 days	Medical Research Council (MRC) dyspnoea scale 100mm Visual Analog Scale for pain and breathlessness
Complication rate	Day 7, 14, 30, 60 and 90	Clinical review and adverse event documentation

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026