Efficacy and Safety of Blue Light Flexible Cystoscopy with Hexaminolevulinate in the Surveillance of Bladder Cancer: A Phase III, Comparative, Multicenter Study
Autor: | Siamak, Daneshmand, Sanjay, Patel, Yair, Lotan, Kamal, Pohar, Edouard, Trabulsi, Michael, Woods, Tracy, Downs, William, Huang, Jeffrey, Jones, Michael, O'Donnell, Trinity, Bivalacqua, Joel, DeCastro, Gary, Steinberg, Ashish, Kamat, Matthew, Resnick, Badrinath, Konety, Mark, Schoenberg, J Stephen, Jones, Christopher, Weight |
---|---|
Rok vydání: | 2017 |
Předmět: |
Adult
Male medicine.medical_specialty Urology 030232 urology & nephrology Malignancy 03 medical and health sciences 0302 clinical medicine Bladder Neoplasm Medicine Humans Prospective Studies Papillary urothelial neoplasm of low malignant potential Blue light Aged Aged 80 and over Bladder cancer Photosensitizing Agents medicine.diagnostic_test business.industry Carcinoma in situ Cystoscopy Aminolevulinic Acid Middle Aged medicine.disease Urinary Bladder Neoplasms 030220 oncology & carcinogenesis Hexaminolevulinate Female Radiology Neoplasm Recurrence Local business |
Zdroj: | The Journal of urology. 199(5) |
ISSN: | 1527-3792 |
Popis: | We compared blue light flexible cystoscopy with white light flexible cystoscopy for the detection of bladder cancer during surveillance.Patients at high risk for recurrence received hexaminolevulinate intravesically before white light flexible cystoscopy and randomization to blue light flexible cystoscopy. All suspicious lesions were documented. Patients with suspicious lesions were referred to the operating room for repeat white and blue light cystoscopy. All suspected lesions were biopsied or resected and specimens were examined by an independent pathology consensus panel. The primary study end point was the proportion of patients with histologically confirmed malignancy detected only with blue light flexible cystoscopy. Additional end points were the false-positive rate, carcinoma in situ detection and additional tumors detected only with blue light cystoscopy.Following surveillance 103 of the 304 patients were referred, including 63 with confirmed malignancy, of whom 26 had carcinoma in situ. In 13 of the 63 patients (20.6%, 95% CI 11.5-32.7) recurrence was seen only with blue light flexible cystoscopy (p0.0001). Five of these cases were confirmed as carcinoma in situ. Operating room examination confirmed carcinoma in situ in 26 of 63 patients (41%), which was detected only with blue light cystoscopy in 9 of the 26 (34.6%, 95% CI 17.2-55.7, p0.0001). Blue light cystoscopy identified additional malignant lesions in 29 of the 63 patients (46%). The false-positive rate was 9.1% for white and blue light cystoscopy. None of the 12 adverse events during surveillance were serious.Office based blue light flexible cystoscopy significantly improves the detection of patients with recurrent bladder cancer and it is safe when used for surveillance. Blue light cystoscopy in the operating room significantly improves the detection of carcinoma in situ and detects lesions that are missed with white light cystoscopy. |
Databáze: | OpenAIRE |
Externí odkaz: |