Photodynamic versus white light-guided treatment of non-muscle invasive bladder cancer: a study protocol for a randomised trial of clinical and cost-effectiveness
Introduction Bladder cancer is the most frequently occurring tumour of the urinary system. Ta, T1 tumours and carcinoma in situ (CIS) are grouped as non-muscle invasive bladder cancer (NMIBC), which can be effectively treated by transurethral resection of bladder tumour (TURBT). There are limitation...
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BMJ Publishing Group
2019-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/9/e022268.full |
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| author | John Norrie Graeme Maclennan Luke Vale Alison McDonald Craig Ramsay Zafer Tandogdu Rebecca Lewis Anne Duncan Steven Penegar Jing Shen John D Kelly Robert Pickard James N Dow Hugh Mostafid Paramananthan Mariappan Ghulam Nabi Joanne Creswell Henry Lazarowicz John McGrath Ernest Taylor Emma Clark Rakesh Heer |
| author_facet | John Norrie Graeme Maclennan Luke Vale Alison McDonald Craig Ramsay Zafer Tandogdu Rebecca Lewis Anne Duncan Steven Penegar Jing Shen John D Kelly Robert Pickard James N Dow Hugh Mostafid Paramananthan Mariappan Ghulam Nabi Joanne Creswell Henry Lazarowicz John McGrath Ernest Taylor Emma Clark Rakesh Heer |
| author_sort | John Norrie |
| collection | DOAJ |
| description | Introduction Bladder cancer is the most frequently occurring tumour of the urinary system. Ta, T1 tumours and carcinoma in situ (CIS) are grouped as non-muscle invasive bladder cancer (NMIBC), which can be effectively treated by transurethral resection of bladder tumour (TURBT). There are limitations to the visualisation of tumours with conventional TURBT using white light illumination within the bladder. Incomplete resections occur from the failure to identify satellite lesions or the full extent of the tumour leading to recurrence and potential risk of disease progression. To improve complete resection, photodynamic diagnosis (PDD) has been proposed as a method that can enhance tumour detection and guide resection. The objective of the current research is to determine whether PDD-guided TURBT is better than conventional white light surgery and whether it is cost-effective.Methods and analysis PHOTO is a pragmatic multicentre randomised controlled trial (open parallel group, non-masked and superiority trial) comparing the intervention of PDD-guided TURBT with standard white light resection in newly diagnosed intermediate and high risk NMIBC within the UK National Health Service setting. Clinical effectiveness is measured with time to recurrence. Cost-effectiveness is assessed within trial via the calculation of incremental cost per recurrence avoided and incremental cost per quality-adjusted life per year gained over 3 years and over long term through a modelling exercise over patients’ lifetime.Ethics and dissemination Formal ethics review was undertaken with a favourable opinion, in line with UK regulatory procedures (REC reference number: 14/NE/1062). If reductions in time to recurrence is associated with long-term patient benefits, the cost-effectiveness evaluation will provide further evidence to inform adoption of the technology. Findings will be shared in lay media such as patient and charity forums and will be presented at key meetings and published in academic literature.Trial registration numberISRCTN84013636. |
| format | Article |
| id | doaj-art-696a084c29bc41b1945cba08f1fa19bb |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-696a084c29bc41b1945cba08f1fa19bb2025-08-20T02:27:57ZengBMJ Publishing GroupBMJ Open2044-60552019-09-019910.1136/bmjopen-2018-022268Photodynamic versus white light-guided treatment of non-muscle invasive bladder cancer: a study protocol for a randomised trial of clinical and cost-effectivenessJohn Norrie0Graeme Maclennan1Luke Vale2Alison McDonald3Craig Ramsay4Zafer Tandogdu5Rebecca Lewis6Anne Duncan7Steven Penegar8Jing Shen9John D Kelly10Robert Pickard11James N Dow12Hugh Mostafid13Paramananthan Mariappan14Ghulam Nabi15Joanne Creswell16Henry Lazarowicz17John McGrath18Ernest Taylor19Emma Clark20Rakesh Heer21Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UKAberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK1 Health Economics Group, Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UKtrial manager10 Health Service Research Unit, University of Aberdeen, Aberdeen, UK1 Urology, Northern Institute for Cancer Research, Newcastle upon Tyne, UKClinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK3 Centre for Healthcare Randomised Trials (CHaRT), University of Aberdeen, Aberdeen, UK4 Urology and Head and Neck Trials Team, Institute of Cancer Research, London, UK6 Health Economics Group, Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK2 Division of Surgery and Interventional Science, University College London, London, UKprofessor of urology9 Department of Surgery, University of Aberdeen, Aberdeen, UK11 Urology, Hampshire Hospitals NHS Foundation Trust, Winchester, UK12 Department of Urology, Western General Hospital, Edinburgh, UK13 Department of Medicine, University of Dundee, Dundee, UK14 Urology, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UKconsultant urological surgeon5 Radiology, Great Lakes Medical Imaging LLC, Buffalo, New York, USA17 Trial Management Group, PHOTO Trial, UK7 Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UKImperial College London NHS Trust, London, UKIntroduction Bladder cancer is the most frequently occurring tumour of the urinary system. Ta, T1 tumours and carcinoma in situ (CIS) are grouped as non-muscle invasive bladder cancer (NMIBC), which can be effectively treated by transurethral resection of bladder tumour (TURBT). There are limitations to the visualisation of tumours with conventional TURBT using white light illumination within the bladder. Incomplete resections occur from the failure to identify satellite lesions or the full extent of the tumour leading to recurrence and potential risk of disease progression. To improve complete resection, photodynamic diagnosis (PDD) has been proposed as a method that can enhance tumour detection and guide resection. The objective of the current research is to determine whether PDD-guided TURBT is better than conventional white light surgery and whether it is cost-effective.Methods and analysis PHOTO is a pragmatic multicentre randomised controlled trial (open parallel group, non-masked and superiority trial) comparing the intervention of PDD-guided TURBT with standard white light resection in newly diagnosed intermediate and high risk NMIBC within the UK National Health Service setting. Clinical effectiveness is measured with time to recurrence. Cost-effectiveness is assessed within trial via the calculation of incremental cost per recurrence avoided and incremental cost per quality-adjusted life per year gained over 3 years and over long term through a modelling exercise over patients’ lifetime.Ethics and dissemination Formal ethics review was undertaken with a favourable opinion, in line with UK regulatory procedures (REC reference number: 14/NE/1062). If reductions in time to recurrence is associated with long-term patient benefits, the cost-effectiveness evaluation will provide further evidence to inform adoption of the technology. Findings will be shared in lay media such as patient and charity forums and will be presented at key meetings and published in academic literature.Trial registration numberISRCTN84013636.https://bmjopen.bmj.com/content/9/9/e022268.full |
| spellingShingle | John Norrie Graeme Maclennan Luke Vale Alison McDonald Craig Ramsay Zafer Tandogdu Rebecca Lewis Anne Duncan Steven Penegar Jing Shen John D Kelly Robert Pickard James N Dow Hugh Mostafid Paramananthan Mariappan Ghulam Nabi Joanne Creswell Henry Lazarowicz John McGrath Ernest Taylor Emma Clark Rakesh Heer Photodynamic versus white light-guided treatment of non-muscle invasive bladder cancer: a study protocol for a randomised trial of clinical and cost-effectiveness BMJ Open |
| title | Photodynamic versus white light-guided treatment of non-muscle invasive bladder cancer: a study protocol for a randomised trial of clinical and cost-effectiveness |
| title_full | Photodynamic versus white light-guided treatment of non-muscle invasive bladder cancer: a study protocol for a randomised trial of clinical and cost-effectiveness |
| title_fullStr | Photodynamic versus white light-guided treatment of non-muscle invasive bladder cancer: a study protocol for a randomised trial of clinical and cost-effectiveness |
| title_full_unstemmed | Photodynamic versus white light-guided treatment of non-muscle invasive bladder cancer: a study protocol for a randomised trial of clinical and cost-effectiveness |
| title_short | Photodynamic versus white light-guided treatment of non-muscle invasive bladder cancer: a study protocol for a randomised trial of clinical and cost-effectiveness |
| title_sort | photodynamic versus white light guided treatment of non muscle invasive bladder cancer a study protocol for a randomised trial of clinical and cost effectiveness |
| url | https://bmjopen.bmj.com/content/9/9/e022268.full |
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