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 (NCT)	NCT00821860
Protocol serial number	2.0
Sponsor	Papworth Hospital NHS Foundation Trust (UK)
Funder	British United Provident Association (BUPA) (UK)

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

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-treatment-for-fluid-around-the-lung-caused-by-mesothelioma

Contact information

Dr Vikki Hughes
Scientific

Papworth Hospital
Papworth Everard
Cambridge
CB23 3RE
United Kingdom

Phone	+44 (0)148 036 4821
Email	victoria.hughes@papworth.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	1. Survival at 1 year 2. Control of effusion 3. Quality of life
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	30/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Papworth Hospital

Cambridge
CB23 3RE
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	20/09/2014		Yes	No

Editorial Notes

MW 13/02/2018: Publication reference added.