Clinical trial NCT02555163: Laser En Bloc Resection Of Bladder Tumor (HoLERBT) VS. Conventional Transurethral Resection Of Bladder Tumors (cTURBT)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: bladder cancer, laser
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-09-21
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: residual disease at re-staging transurethral bladder biopsy
timeFrame: 4 weeks after primary procedure
Secondary outcomes:
measure: periprocedure complications
timeFrame: 2 days
measure: recurrence free survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nprhology Center
state: Aldakahlia
Study officials:
affiliation: Mansoura urology and nephrology center, Mansoura University, Egypt
name: Ahmed M Elshal, MD
role: STUDY_DIRECTOR
References:
citation: Hashem A, Mosbah A, El-Tabey NA, Laymon M, Ibrahiem EH, Elhamid MA, Elshal AM. Holmium Laser En-bloc Resection Versus Conventional Transurethral Resection of Bladder Tumors for Treatment of Non-muscle-invasive Bladder Cancer: A Randomized Clinical Trial. Eur Urol Focus. 2021 Sep;7(5):1035-1043. doi: 10.1016/j.euf.2020.12.003. Epub 2020 Dec 30.