Fluorescence-guided transurethral resection of bladder tumours reduces bladder tumour recurrence due to less residual tumour tissue in Ta/T1 patients: a randomized two-centre study.

OBJECTIVES: •To compare the bladder tumour recurrence rate in stage Ta and T1 tumours after conventional transurethral resection of the bladder in white light (WL TURB) and after fluorescence-guided TURB (HAL TURB) using hexaminolaevulinate (HAL: Hexvix®, Photocure, Norway) for photodynamic diagnosis during 12 months of follow-up. •As secondary objectives, to relate the tumour recurrence rate to fluorescence-detected residual tumour after WL TURB and to assess the false positive rate. PATIENTS AND METHODS: •This was a prospective, comparative, randomized, open-label study carried out in hospital outpatient urology clinics and the operating theatre. A total of 233 patients presenting with suspected superficial bladder tumour were recruited. Both patients with new tumours and patients with recurrent tumours were included. •The study duration was 2.5 years with follow-up cystoscopic investigations at 4, 8 and 12 months. •Patients were randomized to cystoscopy and WL TURB (118 patients) or WL TURB followed immediately by HAL TURB (115 patients). Cystoscopy/TURB and bladder biopsies were performed under general anaesthesia. No patients had intravesical chemotherapy immediately after TURB. •Recurrences were verified histologically.
RESULTS: •The two groups were similar regarding age and previous bladder cancer history. •In all, 90 patients from the HAL TURB group had bladder tumour. Fluorescence-guided cystoscopy after complete WL TURB identified residual tumour tissue in 44 of 90 patients (49%). In 37 of 83 (45%) residual Ta tumour was found; in three of seven residual T1 was found and in four cases carcinoma in situ. •True (and false) positive detection rate of photodynamic diagnosis was 64% (25%) and of white light 83% (16%). •In all, 145 patients were eligible for analysis of tumour recurrence. Twelve patients had their last follow-up after 4 months. The recurrence rate in patients followed for 12 months was 47.3% (35/74) after WL TURB and 30.5% (18/59) after HAL TURB (P= 0.05). •Kaplan-Meier analyses comprising data from all 145 patients showed that the recurrence-free period was significantly longer in the HAL TURB group than in the WL TURB group (P= 0.02).
CONCLUSION: •WL TURB often leaves residual tumour in the bladder. HAL TURB improves the detection of Ta/T1 tumours of the bladder resulting in more complete TURB procedures and thus a reduced recurrence rate.

RCT Entities:   Population Interventions Outcomes