Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4, Canada
Location status: Recruiting
NCT Number: NCT06373419
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Thunder Bay, Ontario, P7B 6V4, Canada
Location status: Recruiting
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participant undergoing bladder tumour resection that has been randomized to this arm.
Participant undergoing bladder tumour resection that has been randomized to this arm.
Time frame: 1 day post-procesure
Presence of muscularis propria (bladder muscle cells) in the pathology sample of the bladder tumour
Time frame: 1 day post-procedure
Incidence of inconclusive pathology due to specimen artifact
Time frame: 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.
Time frame: Intraoperative
In minutes measured from anesthesia induction until placement of the urethral catheter
Time frame: Intraoperative
In minutes, measured from the time the cystoscope sheath is inserted into the participant to the time the cystoscope has been removed
Time frame: 12 weeks post-procedure
Defined as any tumor detection by follow-up cystoscopy after the initial resection
Time frame: 6 hours post-procedure
Defined as a drop in hemoglobin level from pre-op
Time frame: 4 weeks post-procedure
Percentage of participants with post-operative complications
Time frame: 1 day post-procedure
Number of inconclusive pathology due to thermal effect artifact.
Time frame: Intraoperative
In minutes, defined as the time the laser was in use, not including pedal pauses
Time frame: Intraoperative
Measured in kilojoules
Time frame: Intraoperative
Reported according to Clavien-Dindo
Contact information is provided by the study sponsor or research team.
Rabail Siddiqui
CONTACT
Shalyn Littlefield
CONTACT
Thunder Bay Regional Health Research Institute
Other
Thulium Fiber Laser (TFL) Versus MOSES Holmium Laser in the En-bloc Resection of Bladder Tumors: A Randomized Controlled Clinical Study
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