TFL vs MOSES Holmium Laser i en-blok resektion af blæretumorer
Thulium Fiber Laser (TFL) versus MOSES Holmium Laser i en-blok resektion af blæretumorer: En randomiseret kontrolleret klinisk undersøgelse
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Ontario
-
Thunder Bay, Ontario, Canada, P7B 6V4
- Thunder Bay Regional Health Sciences Centre
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Presence of muscularis propria
Tidsramme: 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
Tidsramme: 1 day post-procedure
|
Incidence of inconclusive pathology due to specimen artifact |
1 day post-procedure
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Tumor-free rate (TFR)
Tidsramme: 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
Tidsramme: Intraoperative
|
In minutes measured from anesthesia induction until placement of the urethral catheter |
Intraoperative
|
|
Total procedural time
Tidsramme: 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
Tidsramme: 12 weeks post-procedure
|
Defined as any tumor detection by follow-up cystoscopy after the initial resection |
12 weeks post-procedure
|
|
Total blood loss
Tidsramme: 6 hours post-procedure
|
Defined as a drop in hemoglobin level from pre-op |
6 hours post-procedure
|
|
Rate of complications
Tidsramme: 4 weeks post-procedure
|
Percentage of participants with post-operative complications |
4 weeks post-procedure
|
|
Number of inconclusive pathology
Tidsramme: 1 day post-procedure
|
Number of inconclusive pathology due to thermal effect artifact. |
1 day post-procedure
|
|
Lasing time
Tidsramme: Intraoperative
|
In minutes, defined as the time the laser was in use, not including pedal pauses |
Intraoperative
|
|
Total energy used
Tidsramme: Intraoperative
|
Measured in kilojoules |
Intraoperative
|
|
Frequency and severity of peri-operative complications
Tidsramme: Intraoperative
|
Reported according to Clavien-Dindo |
Intraoperative
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Ahmed Z Ahmed, Thunder Bay Regional Health Sciences Centre
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Mandlige urogenitale sygdomme
- Calculi
- Patologiske Tilstande, Anatomiske
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Urolithiasis
- Urinvejsregning
- Urinblæresygdomme
- Patologiske tilstande, tegn og symptomer
- Urinblæren Calculi
Andre undersøgelses-id-numre
- RP-1007
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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