Photodynamic versus white light-guided treatment of non-muscle invasive bladder cancer: A study protocol for a randomised trial of clinical and cost-effectiveness

Zafer Tandogdu, Rebecca Lewis, Anne Duncan, Steven Penegar, Alison McDonald, Luke Vale, Jing Shen, John D. Kelly, Robert Pickard, James N Dow, Craig Ramsay, Hugh Mostafid, Paramananthan Mariappan, Ghulam Nabi, Joanne Creswell, Henry Lazarowicz, John McGrath, Ernest Taylor, Emma Clark, Graeme MaclennanJohn Norrie, Emma Hall, Rakesh Heer*

*Corresponding author for this work

Research output: Contribution to journalArticle

Abstract

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 number ISRCTN84013636.

Original languageEnglish
Article numbere22268
Number of pages9
JournalBMJ Open
Volume9
Issue number9
DOIs
Publication statusPublished - 3 Sep 2019

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Urinary Bladder Neoplasms
Cost-Benefit Analysis
Light
Recurrence
Neoplasms
Costs and Cost Analysis
Ethics
Charities
Quality-Adjusted Life Years
Carcinoma in Situ
National Health Programs
Lighting
Disease Progression
Urinary Bladder
Randomized Controlled Trials
Exercise
Technology
Research

Keywords

  • bladder cancer
  • cost effectiveness
  • health economics
  • photodynamic diagnosis
  • quality of life
  • sample biorepository

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Photodynamic versus white light-guided treatment of non-muscle invasive bladder cancer : A study protocol for a randomised trial of clinical and cost-effectiveness. / Tandogdu, Zafer; Lewis, Rebecca; Duncan, Anne; Penegar, Steven; McDonald, Alison; Vale, Luke; Shen, Jing; Kelly, John D.; Pickard, Robert; N Dow, James; Ramsay, Craig; Mostafid, Hugh; Mariappan, Paramananthan; Nabi, Ghulam; Creswell, Joanne; Lazarowicz, Henry; McGrath, John; Taylor, Ernest; Clark, Emma; Maclennan, Graeme; Norrie, John; Hall, Emma; Heer, Rakesh.

In: BMJ Open, Vol. 9, No. 9, e22268, 03.09.2019.

Research output: Contribution to journalArticle

Tandogdu, Z, Lewis, R, Duncan, A, Penegar, S, McDonald, A, Vale, L, Shen, J, Kelly, JD, Pickard, R, N Dow, J, Ramsay, C, Mostafid, H, Mariappan, P, Nabi, G, Creswell, J, Lazarowicz, H, McGrath, J, Taylor, E, Clark, E, Maclennan, G, Norrie, J, Hall, E & Heer, R 2019, '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, vol. 9, no. 9, e22268. https://doi.org/10.1136/bmjopen-2018-022268
Tandogdu, Zafer ; Lewis, Rebecca ; Duncan, Anne ; Penegar, Steven ; McDonald, Alison ; Vale, Luke ; Shen, Jing ; Kelly, John D. ; Pickard, Robert ; N Dow, James ; Ramsay, Craig ; Mostafid, Hugh ; Mariappan, Paramananthan ; Nabi, Ghulam ; Creswell, Joanne ; Lazarowicz, Henry ; McGrath, John ; Taylor, Ernest ; Clark, Emma ; Maclennan, Graeme ; Norrie, John ; Hall, Emma ; Heer, Rakesh. / Photodynamic versus white light-guided treatment of non-muscle invasive bladder cancer : A study protocol for a randomised trial of clinical and cost-effectiveness. In: BMJ Open. 2019 ; Vol. 9, No. 9.
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abstract = "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 number ISRCTN84013636.",
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AU - Lewis, Rebecca

AU - Duncan, Anne

AU - Penegar, Steven

AU - McDonald, Alison

AU - Vale, Luke

AU - Shen, Jing

AU - Kelly, John D.

AU - Pickard, Robert

AU - N Dow, James

AU - Ramsay, Craig

AU - Mostafid, Hugh

AU - Mariappan, Paramananthan

AU - Nabi, Ghulam

AU - Creswell, Joanne

AU - Lazarowicz, Henry

AU - McGrath, John

AU - Taylor, Ernest

AU - Clark, Emma

AU - Maclennan, Graeme

AU - Norrie, John

AU - Hall, Emma

AU - Heer, Rakesh

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N2 - 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 number ISRCTN84013636.

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