A randomised controlled trial to assess the efficacy and safety of patient controlled maligant pleural effusion drainage by indwelling ambulatory pleural catheter, compared to standard care

Completed

• Conditions: Pleural effusion; Respiratory

• Registration Number: ISRCTN87514420
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 114

Inclusion Criteria

1. Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis. The diagnosis may be established by:
a. Histocytologically proven pleural malignancy or
b. Recurrent large pleural effusion in the context of histologically proven cancer outside the thorax.
2. Written informed consent

Exclusion Criteria

1. Age < 18 years
2. Beginning chemotherapy in the next 4 weeks
3. Expected survival <3 months
4. Chylothorax
5. Previous lobectomy or pneumonectomy on the side of the effusion
6. Previous attempted pleurodesis
7. Pleural infection
8. Total blood white cell count <1.0 x 109
9. Hypercapnic ventilatory failure
10. Patients who are pregnant or lactating
11. Irreversible bleeding diathesis
12. Irreversible visual impairment
13. Inability to give informed consent or comply with the protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified