TFL vs MOSES Holmium Laser in the En-bloc Resection of Bladder Tumors

Not Applicable

Recruiting

Brief Summary: The goal of this randomized clinical trial is to determine if there is difference in pathological and clinical outcomes between MOSES and TFL in the transurethral laser enucleation of bladder tumors.

The main question it aims to answer is:

Is there a difference in pathological and clinical outcomes between MOSES Holmium and Thulium Fiber Laser (TFL) in the transurethral laser enucleation of bladder tumors?

Participants will randomized to either TFL of MOSES arm for their bladder resection procedure.

Detailed Description: An estimated 12,500 Canadians are diagnosed with bladder cancer each year. Diagnosis and treatment involve transurethral (through the urethra) resection of tumor or tissue called the TURBT procedure. This procedure yields excellent results and minimal morbidity and mortality but has a high recurrence rate, difficulties in the pathologic interpretation of the specimen (due to cautery effect), and procedure-related complications (excessive bleeding, bladder perforation, bowel injury, and inadvertent extensive injury to urethra) that may delay treatments such as chemotherapy which would further impact oncologic outcomes. With the advancement of technology, new methods of transurethral tumor removal have emerged, such as the use of laser energy. Using laser energy, the tumour is resected in one piece, whereas the TURBT approach requires breaking the tumor into pieces. This allows for better pathology analysis that can determine treatment pathways for the patient, as well as reduces the risk of complications. The standard lasers used have been the MOSES Holmium laser and the Thulium Fiber Laser (TFL).

Recruitment & Eligibility

Inclusion Criteria

Over 18 years of age at the time of enrollment.
Patients presented with visual criteria suggesting bladder tumor by outpatient cystoscopy will be legible for inclusion.

Exclusion Criteria

Tumors deemed not eligible for laser resection as determined by the Urologist e.g. obvious muscle-invasive or metastatic at presentation
Synchronous either urethral tumors or upper urinary tract tumor
History of Carcinoma in situ
Contracted bladder

Arm && Interventions

Group	Intervention	Description
Thulium Fibre Laser	TFL	Participants randomized to this arm will undergo bladder resection using the TFL laser
MOSES Holmonium	MOSES holmium laser	Participants randomized to this arm will undergo bladder resection using the MOSES holmium laser.

Primary Outcome Measures

Name	Time	Method
Incidence of inconclusive pathology	1 day post-procedure	Incidence of inconclusive pathology due to specimen artifact
Presence of muscularis propria	1 day post-procesure	Presence of muscularis propria (bladder muscle cells) in the pathology sample of the bladder tumour

Secondary Outcome Measures

Name	Time	Method
Total procedural time	Intraoperative	In minutes, measured from the time the cystoscope sheath is inserted into the participant to the time the cystoscope has been removed
Total blood loss	6 hours post-procedure	Defined as a drop in hemoglobin level from pre-op
Total operative time	Intraoperative	In minutes measured from anesthesia induction until placement of the urethral catheter
Lasing time	Intraoperative	In minutes, defined as the time the laser was in use, not including pedal pauses
Tumor-free rate (TFR)	6 to 12 weeks post-procedure	As per the follow-up cystoscopy, TFR is defined as the absence of any residual tumor detectable by cystoscopy.
Rate of complications	4 weeks post-procedure	Percentage of participants with post-operative complications
Number of recurrences	12 weeks post-procedure	Defined as any tumor detection by follow-up cystoscopy after the initial resection
Number of inconclusive pathology	1 day post-procedure	Number of inconclusive pathology due to thermal effect artifact.
Total energy used	Intraoperative	Measured in kilojoules
Frequency and severity of peri-operative complications	Intraoperative	Reported according to Clavien-Dindo

Locations (1): Thunder Bay Regional Health Sciences Centre
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Thunder Bay, Ontario, Canada