Clinical trial NCT06373419: TFL vs MOSES Holmium Laser in the En-bloc Resection of Bladder Tumors
Official title: Thulium Fiber Laser (TFL) Versus MOSES Holmium Laser in the En-bloc Resection of Bladder Tumors: A Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urolithiasis of Bladder
Lead sponsor: Thunder Bay Regional Health Research Institute
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Presence of muscularis propria
timeFrame: 1 day post-procesure
measure: Incidence of inconclusive pathology
timeFrame: 1 day post-procedure
Secondary outcomes:
measure: Tumor-free rate (TFR)
timeFrame: 6 to 12 weeks post-procedure
measure: Total operative time
timeFrame: Intraoperative
measure: Total procedural time
timeFrame: Intraoperative
measure: Number of recurrences
timeFrame: 12 weeks post-procedure
measure: Total blood loss
timeFrame: 6 hours post-procedure
measure: Rate of complications
timeFrame: 4 weeks post-procedure
measure: Number of inconclusive pathology
timeFrame: 1 day post-procedure
measure: Lasing time
timeFrame: Intraoperative
measure: Total energy used
timeFrame: Intraoperative
measure: Frequency and severity of peri-operative complications
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
Study officials:
affiliation: Thunder Bay Regional Health Sciences Centre
name: Ahmed Z Ahmed
role: PRINCIPAL_INVESTIGATOR
References: