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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thulium Fibre Laser | Active Comparator | Participants randomized to this arm will undergo bladder resection using the TFL laser |
|
| MOSES Holmonium | Active Comparator | Participants randomized to this arm will undergo bladder resection using the MOSES holmium laser. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TFL | Device | Participant undergoing bladder tumour resection that has been randomized to this arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of muscularis propria | Presence of muscularis propria (bladder muscle cells) in the pathology sample of the bladder tumour | 1 day post-procesure |
| Incidence of inconclusive pathology | Incidence of inconclusive pathology due to specimen artifact | 1 day post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor-free rate (TFR) | As per the follow-up cystoscopy, TFR is defined as the absence of any residual tumor detectable by cystoscopy. | 6 to 12 weeks post-procedure |
| Total operative time | In minutes measured from anesthesia induction until placement of the urethral catheter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rabail Siddiqui | Contact | (807) 684-6000 | rabail.siddiqui@tbh.net | |
| Shalyn Littlefield | Contact | (807) 684-6000 | shalyn.littlefield@tbh.net |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed Z Ahmed | Thunder Bay Regional Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thunder Bay Regional Health Sciences Centre | Recruiting | Thunder Bay | Ontario | P7B 6V4 | Canada |
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| ID | Term |
|---|---|
| D001744 | Urinary Bladder Calculi |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| MOSES holmium laser | Device | Participant undergoing bladder tumour resection that has been randomized to this arm. |
|
| 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 | Intraoperative |
| Number of recurrences | Defined as any tumor detection by follow-up cystoscopy after the initial resection | 12 weeks post-procedure |
| Total blood loss | Defined as a drop in hemoglobin level from pre-op | 6 hours post-procedure |
| Rate of complications | Percentage of participants with post-operative complications | 4 weeks post-procedure |
| Number of inconclusive pathology | Number of inconclusive pathology due to thermal effect artifact. | 1 day post-procedure |
| Lasing time | In minutes, defined as the time the laser was in use, not including pedal pauses | Intraoperative |
| Total energy used | Measured in kilojoules | Intraoperative |
| Frequency and severity of peri-operative complications | Reported according to Clavien-Dindo | Intraoperative |
| D000091642 | Urogenital Diseases |
| D014545 | Urinary Calculi |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |