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Video Assisted Thoracoscopic Lobectomy Versus Conventional Open

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Video Assisted Thoracoscopic Lobectomy Versus Conventional Open VIdeo assisted thoracoscopic lobectomy versus conventional Open LobEcTomy for lung cancer, a multi-centre randomised controlled trial with an internal pilot The VIOLET study REC No: 14/LO/2129 ISRCTN No: 13472721 HTA No: 13/04/03 IRAS No: 163516 Details of Sponsor Royal Brompton and Harefield NHS Foundation Trust Sydney Street, London SW3 6NP Tel: +44 (0) 20 7352 8121 x2610 Chief Investigators & Research Team Contact Details Chief Investigator CTEU and Statistical Lead Mr Eric Lim Professor Chris Rogers Consultant Thoracic Surgeon CTEU Bristol Academic Division of Thoracic Surgery Level 7 Queens Building The Royal Brompton Hospital Bristol Royal Infirmary Sydney Street Marlborough Street SW3 6NP Bristol BS2 8HW Tel: +44 (0) 207 351 8591 Tel: +44 (0) 117 34 22507 Email: [email protected] Email: [email protected] Methodologist and Surgeon Principal Investigator Professor Jane Blazeby Mr Timothy Batchelor University of Bristol Consultant Thoracic Surgeon School of Social & Community Medicine Bristol Royal Infirmary Canyage Hall Upper Maudlin Street 39 Whatley Road, Clifton, Bristol Bristol BS8 2PS BS2 8HW Tel: +44 (0) 117 928 7332 Tel: +44 (0)1173423132 Email: [email protected] Email: [email protected] Principal Investigator Pathologist Mr Michael Shackcloth Professor Andrew Nicholson Liverpool Heart and Chest Hospital NHS Royal Brompton & Harefield NHS Foundation Foundation Trust Trust Thomas Drive Sydney Street, Liverpool London L14 3PE SW3 6NP Tel: +44 (0) 151 600 1398 Tel: +44 (0)20 7352 8121 The VIOLET study 13th February 2018 Protocol – version 5.0 © University of Bristol, 2018 Page 1 of 50 Email:[email protected] Email: [email protected] Health Economics Lead Qualitative Researcher Lead Dr Sarah Wordsworth Dr Sangeetha Paramasivan Senior Research Fellow in Health University of Bristol Economics, Health Economic Research Office Room 2.09 Centre Canynge Hall, Old Road Campus, Old Road, Headington 39 Whatley Road Oxford Bristol OX3 7DQ BS8 2PS Tel: 01865 289268 Tel: +44 (0) 117 3314564 Email: [email protected] Email: [email protected] Contents Glossary / abbreviations ....................................................................................................................5 1. Trial summary ..........................................................................................................................7 2. Background ..............................................................................................................................7 2.1 The Clinical Problem ............................................................................................................ 7 2.2 The rationale for VATS ......................................................................................................... 8 2.3 Sustained scientific interest in VATS .................................................................................... 9 2.4 Molecular residual disease detected using next generation sequencing (NGS): sub-study .... 9 3. Aims and objectives ............................................................................................................... 10 4. Plan of Investigation ............................................................................................................... 11 4.1 Trial schema ...................................................................................................................... 11 4.2 Trial design ........................................................................................................................ 11 4.3 Trial population ................................................................................................................. 12 4.3.1 Eligibility criteria - participating centres ............................................................................ 12 4.3.2 Eligibility criteria – participating surgeons ......................................................................... 12 4.3.3 Eligibility criteria – patients ............................................................................................... 12 4.4 Trial interventions ............................................................................................................. 13 4.4.1 Lobectomy via Video Assisted Thoracoscopic Surgery (VATS) ............................................ 13 4.4.2 Lobectomy via Open Surgery ............................................................................................. 13 4.4.3 Analgesia .......................................................................................................................... 14 4.4.4 Translational research ....................................................................................................... 14 4.4.5 Molecular residual disease sub-study ................................................................................ 14 4.5 Primary and secondary outcomes ...................................................................................... 14 4.5.1 Primary outcome .............................................................................................................. 14 4.5.2 Secondary outcomes ......................................................................................................... 15 4.5.3 Molecular residual disease sub-study ................................................................................ 15 4.6 Sample size calculation ...................................................................................................... 15 The VIOLET study 13th February 2018 Protocol – version 5.0 © University of Bristol, 2018 Page 2 of 50 4.6.1 Main RCT .......................................................................................................................... 15 4.6.2 Molecular residual disease sub-study ................................................................................ 16 5. Trial methods ......................................................................................................................... 16 5.1 Description of randomisation and code breaking ............................................................... 16 5.2 Blinding ............................................................................................................................. 17 5.2.1 Research Team.................................................................................................................. 17 5.2.2 Participants ....................................................................................................................... 17 5.2.3 The success of blinding ...................................................................................................... 18 5.3 Design features to minimise bias ....................................................................................... 18 5.3.1 Selection Bias .................................................................................................................... 18 5.3.2 Performance Bias .............................................................................................................. 18 5.3.3 Detection Bias ................................................................................................................... 18 5.3.4 Attrition Bias ..................................................................................................................... 19 5.3.5 Reporting Bias ................................................................................................................... 19 5.4 Quantitative research procedures ..................................................................................... 19 5.4.1 Assessment of patient reported outcomes ........................................................................ 19 5.4.2 Assessment of non-patient reported study outcomes ....................................................... 20 5.4.3 Imaging protocol ............................................................................................................... 20 5.4.4 Assessment of disease progression ................................................................................... 21 5.4.5 Assessment of discharge suitability ................................................................................... 21 5.4.6 Trial Interventions ............................................................................................................. 21 5.4.7 Molecular residual disease sub-study ................................................................................ 22 5.5 Qualitative research procedures ........................................................................................ 22 5.5.1 Qualitative research: data collection ................................................................................. 22 5.5.2 Qualitative Research: Feedback to the CI/TMG & Plan of Action ....................................... 23 5.5.3 Qualitative Research: Evaluation of the Impact of the Plan of Action ................................. 24 5.6 Duration of treatment period ............................................................................................ 24 5.7 Definition of end of trial .................................................................................................... 24 5.7.1 Main RCT .......................................................................................................................... 24 5.7.2 Main RCT and sub-study combined ..................................................................................
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