A randomised trial to determine the best method for delivering talc for the management of malignant pleural effusions in patients with a good performance status

Not Applicable

Completed

• Conditions: Malignant pleural effusion; Cancer; Malignant neoplasm of bronchus and lung

• Registration Number: ISRCTN47845793
• Lead Sponsor: orth Bristol NHS Trust (UK)

Brief Summary

2014 protocol in http://www.ncbi.nlm.nih.gov/pubmed/25428632 2014 strategies in http://www.ncbi.nlm.nih.gov/pubmed/25416527 2019 results in http://www.ncbi.nlm.nih.gov/pubmed/31804680 (added 06/12/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-28
• Study Completion: 2018-10-31
• Last Update Posted: 6 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

1. Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis, defined as:
1.1. Pleural effusion with histocytologically proven pleural malignancy OR
1.2. Pleural effusion in the context of histocytologically proven malignancy elsewhere, without a clear alternative cause for fluid OR
1.3. Pleural effusion with typical features of malignancy with pleural involvement on cross-sectional imaging (CT/MRI)
2. Fit enough to undergo local anaesthetic thoracoscopy, as per British Thoracic Society (BTS) guidelines
3. Expected survival >3 months
4. Written, informed consent to trial participation

Exclusion Criteria

1. Patients in whom thoracoscopy is the only reasonable approach to making a diagnosis, and in whom such a diagnosis would significantly influence further management
2. Age < 18 years
3. Females who are pregnant or lactating
4. Evidence of extensive lung entrapment on chest X-ray (CXR) or CT, or significant fluid loculation on ultrasound scan, to a level which would normally be a contraindication to attempted talc pleurodesis
5. Insufficient volume or position of pleural fluid on lateral decubitus thoracic ultrasound to safely perform local anaesthetic thoracoscopy without further intervention being necessary
6. Previously documented adverse reaction to talc
7. Clear contraindication to thoracoscopy or chest tube insertion

Study & Design

• Study Type: Interventional
• Study Design: Not specified