Prospective randomised controlled trial of video assisted cytoreductive pleurectomy compared to talc pleurodesis in patients with suspected or proven mesothelioma
| ISRCTN | ISRCTN34321019 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34321019 |
| ClinicalTrials.gov number | NCT00821860 |
| Secondary identifying numbers | 2.0 |
- Submission date
- 12/02/2004
- Registration date
- 16/03/2004
- Last edited
- 13/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Vikki Hughes
Scientific
Scientific
Papworth Hospital
Papworth Everard
Cambridge
CB23 3RE
United Kingdom
| Phone | +44 (0)148 036 4821 |
|---|---|
| victoria.hughes@papworth.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Prospective randomised controlled trial of video assisted cytoreductive pleurectomy compared to talc pleurodesis in patients with suspected or proven mesothelioma |
| Study acronym | MesoVATS |
| Study objectives | The MesoVATS trial is a randomised phase III study comparing surgical pleurectomy and palliative pleurodesis to determine which is the better at preventing fluid recurrence. On 15/02/2011 the overall trial end date was changed from 31/12/2009 to 30/06/2012. On 25/01/2012 the overall trial end date was changed from 30/06/2012 to 30/12/2012. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee (LREC) (ref: H02/809) |
| Health condition(s) or problem(s) studied | Mesothelioma |
| Intervention | Group 1 - pleurodesis: A procedure in which a chest tube is placed between the lungs and chest wall, and fluid is drained from the intrapleural space. A talc substance will then be administered through the tube. The chest tube will most likely stay in place for a few days following this procedure, and patients will remain hospitalised for about a week. Group 2 - Video-Assisted Thoracoscopic (VATS) pleurectomy: A chest tube will be inserted between the lungs and chest wall, and fluid will be drained. Surgery will then be performed to remove the pleural membrane. This is done under general anesthetic, and the chest tube will remain in place for up to 10 days. Patients will remain hospitalised for up to two weeks. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Survival at 1 year 2. Control of effusion 3. Quality of life |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/09/2003 |
| Completion date | 30/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 196 |
| Key inclusion criteria | 1. Proven or suspected mesothelioma 2. Pleural tumour with associated pleural effusion 3. Fit enough for Video-Assisted Thoracoscopic (VATS) pleurectomy 4. Patients who have had a previous malignancy for which they are no longer receiving treatment, provided they have a confirmed diagnosis of mesothelioma |
| Key exclusion criteria | 1. Patients who are unfit for a VATS procedure 2. Patients who have had previous attempted pleurodesis 3. Patients without a pleural effusion |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 06/01/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Papworth Hospital
Cambridge
CB23 3RE
United Kingdom
CB23 3RE
United Kingdom
Sponsor information
Papworth Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Papworth Everard
Cambridge
CB3 8RE
England
United Kingdom
| Website | http://www.papworthpeople.com/ |
|---|---|
"ROR" |
https://ror.org/01qbebb31 |
Funders
Funder type
Industry
British United Provident Association (BUPA) (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 20/09/2014 | Yes | No |
Editorial Notes
MW 13/02/2018: Publication reference added.
