title: Optimised photodynamic diagnosis for transurethral resection of the bladder (TURB) in German clinical practice: results of the noninterventional study OPTIC III.
abstract: OBJECTIVE
  White light cystoscopy (WLC) is the standard procedure for visualising non-muscle invasive bladder cancer (NMIBC). However, WLC can fail to detect all cancerous lesions, and outcomes with transurethral resection of the bladder differ between institutions, controlled trials, and possibly between trials and routine application. This noninterventional study assessed the benefit of hexaminolevulinate blue light cystoscopy (HALC; Hexvix®, Ipsen Pharma GmbH, Germany) plus WLC versus WLC alone in routine use.
  
  
  METHODS
  From May 2013 to April 2014, 403 patients with suspected NMIBC were screened from 30 German centres to perform an unprecedented detailed assessment of the additional detection of cancer lesions with HALC versus WLC alone.
  
  
  RESULTS
  Among the histological results for 929 biopsy samples, 94.3 % were obtained from suspected cancerous lesions under either WLC or HALC: 59.5 % were carcinoma tissue and 40.5 % were non-cancerous tissue. Of all cancer lesions, 62.2 % were staged as Ta, 20.1 % as T1, 9.3 % as T2, 7.3 % as carcinoma in situ (CIS), and 1.2 % were unknown. Additional cancer lesions (+6.8 %) and CIS lesions (+25 %, p < 0.0001) were detected by HALC plus WLC versus WLC alone. In 10.0 % of patients, ≥1 additional positive lesion was detected with HALC, and 2.2 % of NMIBC patients would have been missed with WLC alone. No adverse events were observed.
  
  
  CONCLUSIONS
  The results of this study demonstrate that HALC significantly improves the detection of NMIBC versus WLC alone in routine clinical practice in Germany. While this benefit is statistically significant across all types of NMIBC, it seems most relevant in CIS.
authors: Urologisches Zentrum Hamburg, Asklepios Kliniken Hamburg, Hamburg, Germany.
authors: Thorsten
authors: T
authors: Bach
authors: Klinik für Urologie, Marien Hospital, Düsseldorf, Germany.
authors: Patrick J
authors: PJ
authors: Bastian
authors: Klinik für Urologie und Kinderurologie, Klinikum Fürth, Fürth, Germany.
authors: Andreas
authors: A
authors: Blana
authors: Klinik für Urologie, Kliniken Maria Hilf GmbH Mönchengladbach, Mönchengladbach, Germany.
authors: Angelika
authors: A
authors: Kaminsky
authors: Klinikum Garmisch-Partenkirchen GmbH, Urologie, Garmisch-Partenkirchen, Germany.
authors: Stefan
authors: S
authors: Keller
authors: Urologische Klinik Sindelfingen, Sindelfingen, Germany.
authors: Thomas
authors: T
authors: Knoll
authors: Klinik für Urologie, Knappschaftskrankenhaus Sulzbach, Sulzbach, Germany.
authors: Christoph
authors: C
authors: Lang
authors: Klinik für Urologie, Klinikum Frankfurt (Oder), Frankfurt, Germany.
authors: Soeren
authors: S
authors: Promnitz
authors: Klinik für Urologie, Augusta-Krankenanstalt GmbH, Bochum, Germany.
authors: Burkhard
authors: B
authors: Ubrig
authors: ACOMED Statistik Leipzig/Mediveritas GmbH München, Munich, Germany.
authors: Thomas
authors: T
authors: Keller
authors: Ipsen Pharma GmbH, Ettlingen, Germany.
authors: Bryan
authors: B
authors: Qvick
authors: Klinik für Urologie, Universitätsklinikum Regensburg, 93053, Regensburg, Germany. mburger@caritasstjosef.de.
authors: Maximilian
authors: M
authors: Burger
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000622:Aminolevulinic Acid / Q000031:analogs & derivatives; D002278:Carcinoma in Situ / Q000175:diagnosis / Q000473:pathology* / Q000601:surgery; D002295:Carcinoma, Transitional Cell / Q000175:diagnosis / Q000473:pathology* / Q000601:surgery; D003558:Cystoscopy / Q000379:methods*; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D009130:Muscle, Smooth / Q000473:pathology; D060787:Neoplasm Grading; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D017319:Photosensitizing Agents; D001743:Urinary Bladder / Q000473:pathology* / Q000601:surgery; D001749:Urinary Bladder Neoplasms / Q000175:diagnosis / Q000473:pathology* / Q000601:surgery
chemical_list: D017319:Photosensitizing Agents; D000622:Aminolevulinic Acid; C419924:5-aminolevulinic acid hexyl ester
keywords: Blue light cystoscopy; Hexaminolevulinate; Non-muscle invasive bladder cancer; Observational studies; White light cystoscopy