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

Gkritsios 2014.

Study characteristics
Methods
  • randomized

  • single center/Greece

Participants Study setting
  • primary and recurrent


Eligibility criteria
  • patients with suspected or confirmed NMIBC


Non‐eligibility criteria
  • patients scheduled for a second TURBT

  • porphyria

  • gross hematuria

  • known allergy to HAL

  • presence of > 4 solitary tumors

  • large tumors (> 3 cm in diameter)


Intervention cohort
  • participants recruited: 66

  • unifocal/multifocal tumors: NR


Comparator cohort
  • participants recruited: 64

  • unifocal/multifocal tumors: NR

Interventions Intervention: WLC + BLC followed by WL‐TURBT + BL‐TURBT
Comparator: WLC followed by WL‐TURBT
Adjuvant instillation therapy: 50 mg epirubicin
Outcomes Outcome(s)*
  • recurrence‐free survival

  • detection rate

  • recurrence rate

  • false‐positive rate

  • adverse events

  • surgeon opinion on whether blue light "helped them with patient"


Results
  • median follow‐up: 40 months

  • RFS was 31.0 months in intervention group vs 27.0 months in comparator group

  • recurrence rate within 40 months was 37.5% in intervention group vs 45.9% in comparator group (P = 0.507)

  • surgeon opinion: in 34 out of the 54 participants (63%, 95% CI 50.1 to 75.8) blue light was helpful

Funding sources NR
Declarations of interest NR
Contact of study author Date of contact attempt to first study author: 30 November 2020
Contact status: no reply to date
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "randomization plan was produced with the use of an electronic randomization plan generator (randomization.com), with the method of randomly permuted blocks"
Comment: method of sequence generation clearly described
Allocation concealment (selection bias) Unclear risk Quote: "randomization plan was produced with the use of an electronic randomization plan generator (randomization.com), with the method of randomly permuted blocks"
Comment: method of sequence generation clearly described
Blinding of participants and personnel (performance bias)
Surgeon High risk Quote: NA
Comment: surgeon unblinded
Blinding of participants and personnel (performance bias)
Participants/study personnel Unclear risk Quote: NA
Comment: unclear whether study participants and other study personnel were blinded
Blinding of outcome assessment (detection bias)
Subjective outcomes (all outcomes) Unclear risk Quote: NA
Comment: unclear whether study personnel were blinded
Incomplete outcome data (attrition bias)
Oncological outcomes High risk Quote: "excluded from follow‐up n=6 and n=13, respectively (see figure 1)"
Comment: high rate (≥ 20%) of participants lost to follow‐up
Selective reporting (reporting bias) Low risk Quote: NA
Comment: reporting according to the protocol (UMIN000008176) of primary and secondary outcome measures
Other bias Low risk Quote: NA
Comment: no other bias identified