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. 2021 Dec 1;2021(12):CD013776. doi: 10.1002/14651858.CD013776.pub2

Tandogdu 2019.

Study name PHOTOdynamic versus white light‐guided treatment of non‐muscle invasive bladder cancer: randomised trial of clinical and cost‐effectiveness
Methods
  • randomized

  • multicenter

Participants Estimated enrollment
  • 533 participants


Study setting
  • primary

  • only intermediate/high risk


Eligibility criteria
  • visual/ultrasound/CT diagnosis of intermediate‐/high‐risk NMIBC

  • white light visual appearances of intermediate‐ or high‐risk disease (3‐centimeter tumor size, 2 or more tumors, or flat velvety erythematous changes alerting a clinical suspicion of CIS)

  • suspicion of papillary bladder tumour > 3 cm based on ultrasound or CT scanning (without hydronephrosis)


Non‐eligibility criteria
  • visual evidence of low‐risk NMIBC (solitary tumor < 3 cm)

  • visual evidence of MIBC on preliminary cystoscopy, i.e. non‐papillary or sessile mass (attached directly by its base without a stalk)

  • upper tract (kidney or ureteric) tumors on imaging

  • any other malignancy in the past 2 years (except non‐melanomatous skin cancer cured by excision, adequately treated CIS of the cervix, ductal/lobular CIS of the breast, or prostate cancer in patients who have a life expectancy of > 5 years upon trial entry)

  • evidence of metastases

  • porphyria or known hypersensitivity to porphyrins

Interventions Intervention: blue light TURBT
Control: white light TURBT
Outcomes Primary outcomes
  • bladder cancer recurrence at 3 years

  • analysis of cost‐effectiveness


Secondary outcomes
  • progression rate at 3 years

  • safety

  • health‐related quality of life

  • cancer‐specific survival

Starting date September 2014
Contact information Date of contact attempt to first study author: 28 July 2021
Contact status: reply by author 28 July 2021; manuscript is currently being prepared
Notes www.isrctn.com/ISRCTN84013636

CIS: carcinoma in situ

CT: computerized tomography 

MIBC: muscle invasive bladder cancer

NMIBC: non‐muscle invasive bladder cancer

PUNLMP: papillary urothelial neoplasm of low malignant potential

TURBT: transurethral resection of bladder tumor

WHO: World Health Organization