Urolithiasis of Bladder
Conditions
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).
Interventions
DEVICETFL
Participant undergoing bladder tumour resection that has been randomized to this arm.
DEVICEMOSES holmium laser
Participant undergoing bladder tumour resection that has been randomized to this arm.
Sponsors
Thunder Bay Regional Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Over 18 years of age at the time of enrollment. 2. Patients presented with visual criteria suggesting bladder tumor by outpatient cystoscopy will be legible for inclusion.
Exclusion criteria
1. Tumors deemed not eligible for laser resection as determined by the Urologist e.g. obvious muscle-invasive or metastatic at presentation 2. Synchronous either urethral tumors or upper urinary tract tumor 3. History of Carcinoma in situ 4. Contracted bladder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of muscularis propria | 1 day post-procesure | Presence of muscularis propria (bladder muscle cells) in the pathology sample of the bladder tumour |
| Incidence of inconclusive pathology | 1 day post-procedure | Incidence of inconclusive pathology due to specimen artifact |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Total operative time | Intraoperative | In minutes measured from anesthesia induction until placement of the urethral catheter |
| 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 |
| Number of recurrences | 12 weeks post-procedure | Defined as any tumor detection by follow-up cystoscopy after the initial resection |
| Rate of complications | 4 weeks post-procedure | Percentage of participants with post-operative complications |
| Lasing time | Intraoperative | In minutes, defined as the time the laser was in use, not including pedal pauses |
| Total energy used | Intraoperative | Measured in kilojoules |
| Frequency and severity of peri-operative complications | Intraoperative | Reported according to Clavien-Dindo |
| Total blood loss | 6 hours post-procedure | Defined as a drop in hemoglobin level from pre-op |
| Number of inconclusive pathology | 1 day post-procedure | Number of inconclusive pathology due to thermal effect artifact. |
Countries
Canada
Contacts
Primary ContactRabail Siddiqui
Backup ContactShalyn Littlefield
Outcome results
None listed