Trial Registration: trial registry, ClinicalTrials.gov; registration number, NCT00412971; http://www.clinicaltrials.gov/ct2/show/NCT00412971?spons=%22PhotoCure%22&spons_ex=Y&rank=15
Fluorescence-guided transurethral resection of bladder tumours reduces bladder tumour recurrence due to less residual tumour tissue in T a/T1 patients: a randomized two-centre study
Article first published online: 17 MAR 2011
© 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL
Volume 108, Issue 8b, pages E297–E303, October 2011
How to Cite
Hermann, G. G., Mogensen, K., Carlsson, S., Marcussen, N. and Duun, S. (2011), Fluorescence-guided transurethral resection of bladder tumours reduces bladder tumour recurrence due to less residual tumour tissue in T a/T1 patients: a randomized two-centre study. BJU International, 108: E297–E303. doi: 10.1111/j.1464-410X.2011.10090.x
- Issue published online: 10 OCT 2011
- Article first published online: 17 MAR 2011
- Accepted for publication 28 October 2010
- bladder cancer;
- fluorescence cystoscopy;
- residual tumour
Study Type – Therapy (RCT)
Level of Evidence 1b
What’s known on the subject? and What does the study add?
Photodynamic diagnosis (PDD) improves the diagnostic sensitivity of non-invasive bladder cancer as compared to TURB without PDD.
TURB in white light leaves residual tumour in the bladder in up to 49% of the patients. PDD-guided TURB improves the detection of Ta/T1 tumours of the bladder resulting in more complete TURB procedures and thus a reduced tumour recurrence rate.
• 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.
• 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).
• 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.