The efficacy of Indwelling Pleural Catheter placement versus IPC placement PLUS sclerosant (talc) in patients with malignant pleural effusions managed exclusively as out-patients

Not Applicable

Completed

• Conditions: ung cancer; Cancer; Malignant neoplasm of bronchus and lung

• Registration Number: ISRCTN73255764
• Lead Sponsor: orth Bristol NHS Trust (UK)

Brief Summary

2015 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/25880969 protocol 2018 Results article in http://www.ncbi.nlm.nih.gov/pubmed/29617585 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-23
• Study Completion: 2016-03-31
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

1. Symptomatic malignant pleural effusion, agreed at appropriate local / regional MDT to require IPC, defined as pleural fluid in the context of:
1.1. Histocytologically proven pleural malignancy, OR
1.2. Otherwise unexplained pleural effusion in the context of clinically proven cancer elsewhere, OR
1.3. Radiologically proven pleural malignancy as diagnosed in normal clinical practice on thoracic CT in the absence of histocytological proof
2 .Expected survival greater than 2 months
3. Written informed consent to trial participation.
4. Male or female participants
5. Lower Age Limit 18 years

Exclusion Criteria

1. Age < 18 years
2. Females who are pregnant or lactating
3. Patient unable to provide informed consent
4. Previous attempts at pleurodesis on same side as effusion requiring management
5. Previously documented adverse reaction to talc or lidocaine
6. Community services unable to drain indwelling pleural catheter at least twice per week
7. Evidence of extensive lung entrapment on CXR or CT, or significant fluid loculation on ultrasound scan, to a level which would normally be a contraindication to attempted talc pleurodesis or IPC insertion
8. Other contraindication to indwelling pleural catheter insertion

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of patients with successful pleurodesis measured at 5 Weeks

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures