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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Participant undergoing bladder tumour resection that has been randomized to this arm.
Participant undergoing bladder tumour resection that has been randomized to this arm.
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
RECRUITINGPresence of muscularis propria
Presence of muscularis propria (bladder muscle cells) in the pathology sample of the bladder tumour
Time frame: 1 day post-procesure
Incidence of inconclusive pathology
Incidence of inconclusive pathology due to specimen artifact
Time frame: 1 day post-procedure
Tumor-free rate (TFR)
As per the follow-up cystoscopy, TFR is defined as the absence of any residual tumor detectable by cystoscopy.
Time frame: 6 to 12 weeks post-procedure
Total operative time
In minutes measured from anesthesia induction until placement of the urethral catheter
Time frame: Intraoperative
Total procedural time
In minutes, measured from the time the cystoscope sheath is inserted into the participant to the time the cystoscope has been removed
Time frame: Intraoperative
Number of recurrences
Defined as any tumor detection by follow-up cystoscopy after the initial resection
Time frame: 12 weeks post-procedure
Total blood loss
Defined as a drop in hemoglobin level from pre-op
Time frame: 6 hours post-procedure
Rate of complications
Percentage of participants with post-operative complications
Time frame: 4 weeks post-procedure
Number of inconclusive pathology
Number of inconclusive pathology due to thermal effect artifact.
Time frame: 1 day post-procedure
Lasing time
In minutes, defined as the time the laser was in use, not including pedal pauses
Time frame: Intraoperative
Total energy used
Measured in kilojoules
Time frame: Intraoperative
Frequency and severity of peri-operative complications
Reported according to Clavien-Dindo
Time frame: Intraoperative
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