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
| ISRCTN | ISRCTN87514420 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87514420 |
| Clinical Trials Information System (CTIS) | 2006-006630-18 |
| Protocol serial number | TIME 2 |
| Sponsor | University of Oxford (UK) |
| Funder | British Lung Foundation (UK) |
- Submission date
- 07/03/2007
- Registration date
- 30/04/2007
- Last edited
- 19/05/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=48
Contact information
Scientific
Respiratory Trials Unit
Oxford Centre for Respiratory Medicine
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study acronym | The second therapeutic intervention in malignant effusion trial (TIME2) |
| Study objectives | A cancer induced collection of fluid between the lung and the chest wall (a pleural effusion) affects about 250,000 new patients each year (UK&US), including 25% of patients with lung cancer, 95% with mesothelioma and 40% with breast cancer. The accumulated fluid compresses the lung causing disabling breathlessness that requires painful pleural procedures to drain the fluid. Standard care includes adhering the lung to the chest wall (pleurodesis) which is painful and must be repeated in about 20% of patients. This is then followed by repeated fluid drainage if it fails. These procedures carry significant costs. The advent of tunnelled ambulatory small-bore chest catheters, drained as required by patients and their carers, presents a different and potentially better strategy. Treatment could be almost entirely outpatient, with the patient controlling their drainage and free from the pain and costs of pleurodesis/drainage; though with the disadvantage of the indwelling catheter. Patients able to promptly drain their own catheter as needed should produce better breathlessness control than intermittent hospital treatment (the primary aim of pleurodesis). This study is a randomised trial which will compare how well breathlessness is controlled by an indwelling catheter compared to standard care in 114 patients with cancer induced pleural effusion and will measure the frequency of problems with the two treatment strategies. If this trial is positive, it will directly improve care for one of the commonest respiratory problems, to the benefit of >250,000 patients each year. |
| Ethics approval(s) | Milton Keynes Local Research Ethics Committee (ref: 07/Q1603/2) |
| Health condition(s) or problem(s) studied | Pleural effusion |
| Intervention | Patients will be randomly assigned (1:1) to either an indwelling ambulatory pleural catheter or standard care for their malignant pleural effusion. Computer derived allocation will be delivered by the established Oxford/London MRC Clinical Trials Unit systems. In order to minimise biases in trial results randomisation will include minimisation for histological tissue type (mesothelioma vs. non-mesothelioma) as survival is increased in mesothelioma, and the risk of catheter associated subcutaneous tumour invasion may be higher with mesothelioma, and for WHO performance status (0/1 vs. 2/3). |
| Intervention type | Other |
| Primary outcome measure(s) |
The primary outcome will be the average daily Visual Analogue Scale (VAS) defining breathlessness, after removing "breathlessness unresponsive to pleural fluid drainage" - defined as the VAS following first complete pleural fluid drainage. Patients will also record how much their breathlessness has bothered them each day. The daily VAS will be performed at a similar time each day. The patients will perform VAS and record breathlessness for 6 weeks. |
| Key secondary outcome measure(s) |
The following will be assessed at time of the primary outcome measure and recorded throughout the year of the trial: |
| Completion date | 01/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 114 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2006 |
| Date of final enrolment | 01/01/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
OX3 7LJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 13/06/2012 | Yes | No | |
| Results article | results | 01/10/2014 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
