A randomized control trial of fluorescence cystoscopy-assisted en bloc transurethral resection and conventional transurethral resection in patients with non-muscle invasive bladder cancer

A randomized control trial of fluorescence cystoscopy-assisted en bloc transurethral resection and conventional transurethral resection in patients with non-muscle invasive bladder cancer - FLEBER study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000041273

Enrollment

200

Registered

2020-08-01

Start date

2020-08-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-muscle invasive bladder cancer

Interventions

Fluorescence cystoscopy-assisted en bloc transurethral resection Fluorescence cystoscopy-assisted conventional transurethral resection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients undergoing fluorescence cystoscopy-assisted transurethral resection of bladder tumor and the tumor size (longer diameter) is 6 mm to 30 mm. In patients with multiple tumors, the largest tumor is evaluated. 2) Clinical stage, TaN0M0 or T1N0M0 3) ECOG-Performance Status : 0 to 2 4) Age, 20 to 85 yo 5) Sufficient bone marrow function and organ functions within 60 days before the registration

Exclusion criteria

Exclusion criteria: 1) Suspected of having carcinoma in situ (CIS) 2) History of allergic reaction to 5-aminolevulinic acid 3) Patients with clinically significant liver dysfucntion and liver inflammation 4) Patients with porphyria 5) Patients who can not agree with enrollment of the study by his/her own intention 6) Inappropriate for the enrolment by the judgement of the physician

Design outcomes

Primary

Measure	Time frame
Two-year recurrence-free rate	—

Secondary

Measure	Time frame
1) Recurrence-free survival 2) Progression-free survival and progression-free rate (Progression: Ta to T1 or muscle-invasive disease) 3) Upper urinary tract cancer-free survival 4) Metastasis-free survival 5) Cancer-specific survival 6) Overall survival 7) Operation time 8) Postoperative change of blood hemoglobin level 9) Pathological complete resection rate 10) Postoperative change of urinary frequency at 1, 3, and 6 months after transurethral resection (evaluation with frequency volume chart) 11) Rate of adverse events (evaluation with CTCAE ver 5) 12) Postoperative change of health-related quality of life (evaluation with SF-8, EORTC QLQ-C30, and FACT-BL) 13) Postoperative change of lower urinary tract symptoms (evaluation with IPSS and OABSS) 14) Postoperative pain (evaluation with NPRS, VAS, and FAS) 15) Operative scar at 3 and 6 months after transurethral resection (evaluation with cystoscopy) 16) Influence of tumor location (trigon, posterior wall, dome, anterior wall, right wall, left wall, and bladder neck) in primary and secondary endpoints	—

Measure

Time frame

1) Recurrence-free survival 2) Progression-free survival and progression-free rate (Progression: Ta to T1 or muscle-invasive disease) 3) Upper urinary tract cancer-free survival 4) Metastasis-free survival 5) Cancer-specific survival 6) Overall survival 7) Operation time 8) Postoperative change of blood hemoglobin level 9) Pathological complete resection rate 10) Postoperative change of urinary frequency at 1, 3, and 6 months after transurethral resection (evaluation with frequency volume chart) 11) Rate of adverse events (evaluation with CTCAE ver 5) 12) Postoperative change of health-related quality of life (evaluation with SF-8, EORTC QLQ-C30, and FACT-BL) 13) Postoperative change of lower urinary tract symptoms (evaluation with IPSS and OABSS) 14) Postoperative pain (evaluation with NPRS, VAS, and FAS) 15) Operative scar at 3 and 6 months after transurethral resection (evaluation with cystoscopy) 16) Influence of tumor location (trigon, posterior wall, dome, anterior wall, right wall, left wall, and bladder neck) in primary and secondary endpoints

—

Countries

Japan

Contacts

Public ContactMakito Miyake

Nara Medical University Urology

urology@naramed-u.ac.jp0744-22-3051

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026