TFL vs MOSES Holmium Laser i en-block resektion av blåstumörer
Thulium Fiber Laser (TFL) kontra MOSES Holmium Laser i en-block resektion av blåstumörer: en randomiserad kontrollerad klinisk studie
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Ontario
-
Thunder Bay, Ontario, Kanada, P7B 6V4
- Thunder Bay Regional Health Sciences Centre
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Over 18 years of age at the time of enrollment.
- Patients presented with visual criteria suggesting bladder tumor by outpatient cystoscopy will be legible for inclusion.
Exclusion Criteria:
- Tumors deemed not eligible for laser resection as determined by the Urologist e.g. obvious muscle-invasive or metastatic at presentation
- Synchronous either urethral tumors or upper urinary tract tumor
- History of Carcinoma in situ
- Contracted bladder
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Thulium Fibre Laser
Participants randomized to this arm will undergo bladder resection using the TFL laser |
Participant undergoing bladder tumour resection that has been randomized to this arm. |
|
Aktiv komparator: MOSES Holmonium
Participants randomized to this arm will undergo bladder resection using the MOSES holmium laser. |
Participant undergoing bladder tumour resection that has been randomized to this arm. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Presence of muscularis propria
Tidsram: 1 day post-procesure
|
Presence of muscularis propria (bladder muscle cells) in the pathology sample of the bladder tumour |
1 day post-procesure
|
|
Incidence of inconclusive pathology
Tidsram: 1 day post-procedure
|
Incidence of inconclusive pathology due to specimen artifact |
1 day post-procedure
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Tumor-free rate (TFR)
Tidsram: 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. |
6 to 12 weeks post-procedure
|
|
Total operative time
Tidsram: Intraoperative
|
In minutes measured from anesthesia induction until placement of the urethral catheter |
Intraoperative
|
|
Total procedural time
Tidsram: Intraoperative
|
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
Tidsram: 12 weeks post-procedure
|
Defined as any tumor detection by follow-up cystoscopy after the initial resection |
12 weeks post-procedure
|
|
Total blood loss
Tidsram: 6 hours post-procedure
|
Defined as a drop in hemoglobin level from pre-op |
6 hours post-procedure
|
|
Rate of complications
Tidsram: 4 weeks post-procedure
|
Percentage of participants with post-operative complications |
4 weeks post-procedure
|
|
Number of inconclusive pathology
Tidsram: 1 day post-procedure
|
Number of inconclusive pathology due to thermal effect artifact. |
1 day post-procedure
|
|
Lasing time
Tidsram: Intraoperative
|
In minutes, defined as the time the laser was in use, not including pedal pauses |
Intraoperative
|
|
Total energy used
Tidsram: Intraoperative
|
Measured in kilojoules |
Intraoperative
|
|
Frequency and severity of peri-operative complications
Tidsram: Intraoperative
|
Reported according to Clavien-Dindo |
Intraoperative
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Ahmed Z Ahmed, Thunder Bay Regional Health Sciences Centre
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Manliga urogenitala sjukdomar
- Calculi
- Patologiska tillstånd, anatomiska
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Urolithiasis
- Urinvägar
- Sjukdomar i urinblåsan
- Patologiska tillstånd, tecken och symtom
- Urinblåsan Calculi
Andra studie-ID-nummer
- RP-1007
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