Introduction: A prospective, randomized, long term study was performed aiming to compare the long term recurrence rates provided by the hexaminolevulinate blue light cystoscopy (HAL-BLC) versus standard white light cystoscopy (WLC) in cases of non-muscle invasive bladder cancer (NMIBC).
Methods: A total of 362 NMIBC suspected patients were included in the trial based on positive urinary cytology and/or ultrasonographic suspicion of bladder tumors. The 181 cases of the study group underwent both WLC and HAL-BLC, while patients in the control group benefited from standard cystoscopy alone. The follow-up protocol consisted of abdominal ultrasound, urinary cytology and WLC, performed every 3 months for a period of 2 years and every 6 months in the third year.
Results: In the 142 NMIBC patients of the study group, HAL-BLC emphasized significantly improved CIS (95.2% versus 71.4%), pTa (95.3% versus 87.1%) and overall (95.8% versus 85.9%) cases’ detection rates. Additional tumors were found by HAL-BLC in a significantly higher proportion of cases (35.2% versus 14.1%). Consequently, the recurrence (16.2% versus 4.9%) and progression (21.1% versus 7%) risk categories of patients changed significantly due to HAL-BLC by comparison to WLC. The postoperative treatment was modified due to HAL-BLC for a significantly larger proportion of patients (19% versus 6.3%). The 3 months’ recurrence rate was significantly lower in the HAL-BLC series (6.9% versus 15.1%) due to fewer other site recurrences (0.9% versus 6.6%). The overall 1 (20.9% versus 31.1%), 2 (30.4% versus 44.3%) and 3 (35.6% versus 51.9%) years’ recurrence rates were significantly reduced in the HAL-BLC study arm.
Conclusions: HAL-BLC emphasized superior NMIBC patients’ detection rates as well as a significant impact in terms of additional tumors’ cases, risk category changes and postoperative treatment modifications. Subsequently, the 3 months’, 1, 2 and 3 years’ recurrence rates were significantly improved in the HAL-BLC group.