A trial looking at thoracoscopy and talc versus indwelling pleural catheters plus thoracoscopy and talc for management of malignant pleural effusio

Not Applicable

Conditions: Malignant pleural effusion
Cancer
Secondary malignant neoplasm of pleura

Registration Number: ISRCTN11058680

Lead Sponsor: orth Bristol NHS Trust

Brief Summary: 2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37253535/ protocol (added 31/05/2023)

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 124

Inclusion Criteria

1. Symptomatic pleural effusion and any of the following:
1.1. Thoracoscopically confirmed evidence of malignant pleural disease (visible cancer at thoracoscopy) which requires talc poudrage as part of routine clinical care
1.2. An established diagnosis of malignant pleural effusion (via biopsy or cytology) which requires drainage and pleurodesis as per standard care, where the patient/operator decide on a thoracoscopic treatment
1.3. Symptomatic effusion requiring drainage and pleurodesis in the context of established metastatic disease
2. Able to consent to trial inclusion

Exclusion Criteria

1. Technically unable to undergo thoracoscopy and talc poudrage (e.g. gross respiratory failure, uncorrectable clotting, unable to tolerate position, significant suspicion of underlying trapped lung or poor performance status)
2. Visual impairment (precluding use of symptom measurement instruments)
3. Previous talc pleurodesis within the last 3 months on ipsilateral side
4. No means of phone contact
5. Age <18 years
6. Females who are pregnant or lactating
7. Unable to consent to trial inclusion

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The co-primary outcomes are:<br>1. Total number of days spent in hospital (including re-admissions) captured from patient diaries and medical records over 4 weeks post-procedure<br>2. Breathlessness score over 4 weeks post-procedure measured using a 100 mm visual analogue score (VAS) at baseline and then twice weekly for 4 weeks

Secondary Outcome Measures