BMJ Open (Oct 2019)
Study protocol for VIdeo assisted thoracoscopic lobectomy versus conventional Open LobEcTomy for lung cancer, a UK multicentre randomised controlled trial with an internal pilot (the VIOLET study)
- Tim Batchelor,
- Babu Naidu,
- Chris A Rogers,
- Jane Blazeby,
- Alan Kirk,
- Paula Rogers,
- Stacey Stewart,
- Syed Qadri,
- Fiona Strachan,
- Sarah Wordsworth,
- Susan J Dutton,
- Arjun Nair,
- Amy Kerr,
- Rajesh Shah,
- Lisa Jones,
- Elizabeth A Stokes,
- Mark Ainsworth,
- Kathryn Saunders,
- Daisy Elliott,
- Rosie Harris,
- Sangeetha Paramasivan,
- Tom Treasure,
- Martyn Cain,
- Eric Lim,
- Michael Shackcloth,
- Joel Dunning,
- Niall McGonigle,
- Tim Brush,
- Lucy Dabner,
- Holly E Mckeon,
- Dawn Phillips,
- Holly Mckeon,
- Chloe Beard,
- Alba Realpe Rojas,
- Elizabeth Stokes,
- Andrew G Nicholson,
- Sofina Begum,
- Simon Jordan,
- Paulo De Sousa,
- Monica Tavares Barbosa,
- Eveline Internullo,
- Rakesh Krishnadas,
- Gianluca Casali,
- Doug West,
- Karen Bobruk,
- Catherine O’Donovan,
- Louise Flintoff,
- Amelia Lowe,
- Joanna Nicklin,
- Emma Heron,
- Jo Chambers,
- Becky Houlihan,
- Laura Beacham,
- Heather Hudson,
- Katy Tucker,
- Toni Farmery,
- Danielle Davis,
- Mike Shackcloth,
- Julius Asante-Siaw,
- Susannah Love,
- Sarah Feeney,
- Lindsey Murphy,
- Almudena Duran Rosas,
- Andrea Young,
- Ian Paul,
- Hyder Latif,
- Charlotte Jacobs,
- Alison Chilvers,
- Edward Stephenson,
- Nazalie Iqbal,
- Vladimir Anikin,
- Claire Prendergast,
- Hazem Fallouh,
- Maninder Kalkat,
- Richard Steyn,
- Nicola Oswald,
- Charlotte Ferris,
- Jo Webb,
- Joanne Taylor,
- Hollie Bancroft,
- Salma Kadiri,
- Zara Jalal Senior,
- Elizabeth Belcher,
- Dionisios Stavroulias,
- Francesco Di Chiara,
- May Havinden-Williams,
- Mahmoud Loubani,
- Karen Dobbs,
- Paul Atkin,
- Dominic Fellowes,
- Leanne Cox,
- Vipin Zamvar,
- Ruth Langley,
- Joy Adamson,
- Ian Hunt,
- Peter B Licht,
- Chris Hall,
- Mike Cowen,
- Keith Kerr,
- Nagmi Qureshi
Affiliations
- Tim Batchelor
- Cardiothoracic Surgery, Barts Health NHS Trust, London, UK
- Babu Naidu
- Department of Thoracic Surgery, University Hospitals Birmingham, Birmingham, UK
- Chris A Rogers
- 1 Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK
- Jane Blazeby
- professor
- Alan Kirk
- Paula Rogers
- Royal Brompton & Harefield NHS Foundation Trust Hospital, Uxbridge, UK
- Stacey Stewart
- BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK
- Syed Qadri
- Fiona Strachan
- Sarah Wordsworth
- University of Oxford, University of Oxford, Oxford, UK
- Susan J Dutton
- Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
- Arjun Nair
- University College Hospital, London, UK
- Amy Kerr
- Department of Thoracic Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
- Rajesh Shah
- Department of Thoracic Surgery, University Hospital of South Manchester NHS Foundation Trust, Manchester, UK
- Lisa Jones
- 5 Medicine, Division of Pulmonary and Critical Care Medicine, University of Florida College of Medicine – Jacksonville, Jacksonville, Florida, USA
- Elizabeth A Stokes
- Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK
- Mark Ainsworth
- 3 Oxford Liver Unit, Department of Gastroenterology and Hepatology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
- Kathryn Saunders
- 6 Biomedical Sciences Research Institute, Ulster University, Coleraine, UK
- Daisy Elliott
- National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK
- Rosie Harris
- 1 Bristol Medical School, University of Bristol Faculty of Health Sciences, Bristol, UK
- Sangeetha Paramasivan
- Population Health Sciences, University of Bristol, Bristol, UK
- Tom Treasure
- professor of cardiothoracic surgery
- Martyn Cain
- Eric Lim
- Department of Thoracic Surgery, Royal Brompton Hospital, London, UK
- Michael Shackcloth
- 3 Department of Thoracic Surgery, Liverpool Heart and Chest Hospital, Liverpool, UK
- Joel Dunning
- Department of Cardiothoracic Surgery, James Cook University Hospital, Middlesbrough, UK
- Niall McGonigle
- 5 Department of Thoracic Surgery, Royal Brompton and Harefield, Harefield Hospital, London, UK
- Tim Brush
- Bristol Trials Centre (CTEU), Bristol Medical School, University of Bristol, Bristol, UK
- Lucy Dabner
- 6 Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK
- Holly E Mckeon
- 6 Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK
- Dawn Phillips
- Blood Safety, Hepatitis, STI and HIV Division, UK Health Security Agency, London, UK
- Holly Mckeon
- Bristol Trials Centre, Clinical Trials and Evaluation Unit, Bristol Medical School, University of Bristol, Bristol, UK
- Chloe Beard
- Bristol Trials Centre, University of Bristol Medical School, Bristol, UK
- Alba Realpe Rojas
- Elizabeth Stokes
- Andrew G Nicholson
- 2 Respiratory Pathology, National Heart and Lung Institute, Imperial College London, London, UK
- Sofina Begum
- Simon Jordan
- Paulo De Sousa
- Monica Tavares Barbosa
- Eveline Internullo
- Rakesh Krishnadas
- Gianluca Casali
- Department of Surgery, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
- Doug West
- 6 Thoracic Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK
- Karen Bobruk
- Catherine O’Donovan
- Louise Flintoff
- Amelia Lowe
- Joanna Nicklin
- Division of Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK
- Emma Heron
- Jo Chambers
- Becky Houlihan
- Laura Beacham
- Heather Hudson
- Katy Tucker
- Toni Farmery
- Danielle Davis
- Mike Shackcloth
- Julius Asante-Siaw
- Susannah Love
- Sarah Feeney
- Lindsey Murphy
- Almudena Duran Rosas
- Andrea Young
- Ian Paul
- Hyder Latif
- Charlotte Jacobs
- Alison Chilvers
- Edward Stephenson
- Nazalie Iqbal
- Vladimir Anikin
- Biosciences, College of Health, Medicine and Life Sciences, Brunel University London, Uxbridge, UK
- Claire Prendergast
- 1Dorothy House Hospice Care, Winsley, UK
- Hazem Fallouh
- Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK
- Maninder Kalkat
- Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK
- Richard Steyn
- Department of Thoracic Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
- Nicola Oswald
- Charlotte Ferris
- Jo Webb
- Joanne Taylor
- Hollie Bancroft
- Salma Kadiri
- Department of Thoracic Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
- Zara Jalal Senior
- Elizabeth Belcher
- Oxford University Hospitals NHS Foundation Trust, Oxford, UK
- Dionisios Stavroulias
- Department of Thoracic Surgery, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
- Francesco Di Chiara
- May Havinden-Williams
- Mahmoud Loubani
- Karen Dobbs
- Paul Atkin
- Dominic Fellowes
- Leanne Cox
- Vipin Zamvar
- Cardiothoracic Surgery, Royal Infirmary of Edinburgh, Edinburgh, UK
- Ruth Langley
- Institute of Clinical Trials and Methodology - MRC CTU at UCL, University College London, London, UK
- Joy Adamson
- Department of Health Sciences, University of York, York, UK
- Ian Hunt
- 2College of Sciences and Engineering, University of Tasmania, Tasmania, TAS, Australia
- Peter B Licht
- Chris Hall
- Mike Cowen
- Keith Kerr
- Nagmi Qureshi
- DOI
- https://doi.org/10.1136/bmjopen-2019-029507
- Journal volume & issue
-
Vol. 9,
no. 10
Abstract
Introduction Lung cancer is a leading cause of cancer deaths worldwide and surgery remains the main treatment for early stage disease. Prior to the introduction of video-assisted thoracoscopic surgery (VATS), lung resection for cancer was undertaken through an open thoracotomy. To date, the evidence base supporting the different surgical approaches is based on non-randomised studies, small randomised trials and is focused mainly on short-term in-hospital outcomes.Methods and analysis The VIdeo assisted thoracoscopic lobectomy versus conventional Open LobEcTomy for lung cancer study is a UK multicentre parallel group randomised controlled trial (RCT) with blinding of outcome assessors and participants (to hospital discharge) comparing the effectiveness, cost-effectiveness and acceptability of VATS lobectomy versus open lobectomy for treatment of lung cancer. We will test the hypothesis that VATS lobectomy is superior to open lobectomy with respect to self-reported physical function 5 weeks after randomisation (approximately 1 month after surgery). Secondary outcomes include assessment of efficacy (hospital stay, pain, proportion and time to uptake of chemotherapy), measures of safety (adverse health events), oncological outcomes (proportion of patients upstaged to pathologic N2 (pN2) disease and disease-free survival), overall survival and health related quality of life to 1 year. The QuinteT Recruitment Intervention is integrated into the trial to optimise recruitment.Ethics and dissemination This trial has been approved by the UK (Dulwich) National Research Ethics Service Committee London. Findings will be written-up as methodology papers for conference presentation, and publication in peer-reviewed journals. Many aspects of the feasibility work will inform surgical RCTs in general and these will be reported at methodology meetings. We will also link with lung cancer clinical studies groups. The patient and public involvement group that works with the Respiratory Biomedical Research Unit at the Brompton Hospital will help identify how we can best publicise the findings.Trial registration number ISRCTN13472721
