Laser En Bloc Resection Of Bladder Tumor (HoLERBT) VS. Conventional Transurethral Resection Of Bladder Tumors (cTURBT)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Holmium (Ho: YAG) Laser En Bloc Resection Of Bladder Tumor (HoLERBT) Versus Conventional Transurethral Resection Of Bladder Tumors (cTURBT): A Prospective Randomized Controlled Trial

Conditions
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Bladder Cancer

Intervention / Treatment
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* Device: HoLERBT
* Device: cTURBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed at the out-patient cystoscopy with papillary bladder tumour will be legible for inclusion Exclusion Criteria: Tumor criteria Non papillary gross features of the tumor Anteriorly located tumor Patients criteria Poor performance status History of BCG sepsis History of bladder irradiation Contracted bladder
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HoLERBT<br>Holmium (Ho: YAG) Laser En Bloc Resection Of Bladder Tumor | Device: HoLERBT<br>* Using holmium laser, the tumour will be removed as one piece from its base working underneath the muscle layer<br>|
| Active Comparator: cTURBT<br>Conventional Transurethral Resection Of Bladder Tumors | Device: cTURBT<br>* using the conventional electrocautery device with the cutting hot loop the tumor will be removed in pieces<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| residual disease at re-staging transurethral bladder biopsy | 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 | 4 weeks after primary procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| periprocedure complications | Modified Clavien scale will be used for reporting and comparison of periprocedure complications | 2 days | 
| recurrence free survival | Number of patients surviving for one year without tumor recurrence will be counted and compared | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bladder cancer, laser