Bladder Cancer Clinical Trial
Official title:
Holmium (Ho: YAG) Laser En Bloc Resection Of Bladder Tumor (HoLERBT) Versus Conventional Transurethral Resection Of Bladder Tumors (cTURBT): A Prospective Randomized Controlled Trial
Randomized clinical trial aiming to assess Holmium Laser En Bloc Resection Of Bladder Tumor (HoLERBT) in comparison with Conventional Transurethral Resection Of Bladder Tumors (cTURBT) in tumor histopathological staging quality, detrusor muscle sampling in biopsy, completeness of tumor resection and peri procedure complication.
Urothelial carcinoma of the bladder is the 2nd most common urological malignancy and it makes
a growing healthcare problem worldwide.
The vast majority of newly diagnosed are non-muscle bladder cancers (NMIBC) which represents
about 75% and can be treated with transurethral resection of bladder tumors (TURBT) so,
correct initial staging is critical. The quality of TURBT strongly determines patient
prognosis and overall treatment.
Conventional transurethral resection of bladder tumors (cTURBT) causes fragmentation,
artifacts, thermal damages and tangential sections that might hamper histopathological
evaluation.
The expert meeting at Davos of the European Association of Urology (EAU) section of
Uro-Technology (ESUT) and the section of Uro-Oncology (ESOU) identified en bloc resections of
bladder tumors (ERBT) using various energy sources or modified resection loops as a promising
technique.
Laser therapy for the treatment of non muscle invasive bladder tumor (NMIBC) was first
reported in the 1970s. Neodymium:YAG lasers were mainly used for tissue vaporization.
Afterward, the introductions of en bloc resection methods have laser treatments for bladder
cancer regains its popularity. The most commonly used are holmium (Ho:YAG) and thulium
(Tm:YAG).
EBRBT overall complication rate of 0.7%, of which all complications had not been
life-threatening. Compared conventional TURBT to HoLERBT, a significant reduction of
obturator nerve reflex, related bladder perforations, peri- or postoperative bleeding was
rare, reduction in bladder irrigation time in comparison with conventional TURB. Better
histopathological results were with laser en bloc resection of bladder cancer by lowering of
thermal damage The study will be conducted in a single tertiary centre at Urology and
Nephrology Center in Mansoura, Egypt.
Eligible patient presented with papillary bladder tumor will be asked to participate in this
study and will be provided with an informed consent form in line with Good Clinical Practise
and the Declaration of Helsinki.
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