Laser En Bloc Resection Of Bladder Tumor (HoLERBT) VS. Conventional Transurethral Resection Of Bladder Tumors (cTURBT) (HoLERBT)
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|ClinicalTrials.gov Identifier: NCT02555163|
Recruitment Status : Active, not recruiting
First Posted : September 21, 2015
Last Update Posted : March 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Device: HoLERBT Device: cTURBT||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||September 2019|
Holmium (Ho: YAG) Laser En Bloc Resection Of Bladder Tumor
Using holmium laser, the tumour will be removed as one piece from its base working underneath the muscle layer
Active Comparator: cTURBT
Conventional Transurethral Resection Of Bladder Tumors
using the conventional electrocautery device with the cutting hot loop the tumor will be removed in pieces
- residual disease at re-staging transurethral bladder biopsy [ Time Frame: 4 weeks after primary procedure ]Rebiopsy of the tumor base for detection of any residual disease at re staging TUR 4 weeks after primary procedure. Number of patients with residual disease at restaginf TUR will be counted in each arm and compared
- periprocedure complications [ Time Frame: 2 days ]Modified Clavien scale will be used for reporting and comparison of periprocedure complications
- recurrence free survival [ Time Frame: 1 year ]Number of patients surviving for one year without tumor recurrence will be counted and compared
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02555163
|Urology and Nprhology Center|
|Mansoura, Aldakahlia, Egypt, 35516|
|Study Director:||Ahmed M Elshal, MD||Mansoura urology and nephrology center, Mansoura University, Egypt|