Clinical trial NCT06818799: Thulium Laser En-bloc Resection of Primary Non-muscle Invasive Bladder Cancer
Official title: Evaluation of Thulium Laser Endoscopic En-bloc Resection Versus Conventional Trans-urethral En-bloc Resection of Primary Non-muscle Invasive Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Transitional Cell Carcinoma
Keywords: Thulium laser resection of bladder mass
Trans-urethral resection of bladder mass
Non muscle-invasive bladder cancer
Lead sponsor: Helwan University
Sponsor class: OTHER
Collaborators: name: Ain Shams University
name: Maadi Military Hospital
First posted: 2025-02-10
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to know if thulium laser works to treat non-muscle invasive bladder cancer "NMIBC" efficiently in comparison to classical trans-urethral resection "TURBT". It will also learn about the safety of this technique. The main questions it aims to answer are:

Does thulium laser lower the incidence of recurrence to participants with non- muscle invasive bladder cancer? What complications do participants have when using this technique? Investigators will compare thulium laser en-bloc resection to a classical trans-urethral en-bloc resection of bladder tumor

Participants will:

Do thulium laser en-bloc resection or trans-urethral en-bloc resection And will be classified to risk group according to European association of urology guidelines and followed up accordingly.

Detailed description: The conventional transurethral resection of bladder tumor (TURBT) is the most common strategy for NMIBC and it is recommended by the guidelines. However, the TURBT has a complication rate of \~4-6%, of which urinary tract infections and significant haematuria are most common.

In some cases, major complications including obturator nerve reflex (ONR) and bladder perforation could occur. To overcome these drawbacks, lasers including holmium YAG and thulium YAG were introduced. Several studies have suggested the superior safety of Thulium laser resection of bladder tumors (TmLRBT) compared with conventional TURBT.

The TmLRBT is increasingly used in the treatment of NMIBC recently, but whether it can provide better cancer control than TURBT is still unclear.

Previous studies have compared the recurrence rates of these two therapies but no significant difference was detected.However, in all these studies, intravesical therapies were conducted using epirubicin or mitomycin C, instead of bacillus Calmette-Guérin (BCG), which is superior for preventing the recurrence of NMIBC.

En-bloc resection of bladder tumor (ERBT) was first described by Kawada et al. in 1997 and has been used by urologists since then. The main advantage of ERBT is that it can resect and extract the entire tumor with a high-quality specimen rather than piecemeal, overcoming some of the short comings of TURBT.

ERBT provides up to 95% of the detrusor muscle, thus leading to a more accurate pathological diagnosis. En-bloc resection is another well recognized procedure that can be performed with various types of energy, such as 2-μm continue-wave laser, holmium laser, Thulium laser, green-light laser, Hybrid-Knife, etc.

The aim of this study is to evaluate and compare the outcome of Thulium laser with the Electrical Trans-urethral en-bloc resection of non-muscle invasive bladder carcinoma regarding efficacy and complications.

Eligibility criteria: Inclusion Criteria:

* Age : adults and older adults
* patients with bladder transitional cell carcinoma
* Imaging examinations showed small bladder mass \< 3 cm and the bladder muscle has not been affected, no lymph node metastasis or distant metastasis;
* Primary tumor

Exclusion Criteria:

* Large bladder mass \> 3 cm measured by CT urography
* Recurrent tumor
* Patients that confirmed post operative histopathology with muscle-invasive bladder transitional cell carcinoma
* Received previous chemotherapy or radiotherapy
* Other pathological types of bladder cancer

Primary outcomes:
measure: Recurrence free survival rate
timeFrame: 12 months
measure: Local recurrence rate
timeFrame: 12 months
Secondary outcomes:
measure: Peri-operative complications
timeFrame: Intra operative to 1 week post operative duration
Other outcomes:
Locations:
city: Helwan
country: Egypt
facility: Helwan university
state: Cairo
Study officials:
affiliation: Tarek Abdel magied Salem
name: Tarek AM Salem, MD
role: STUDY_CHAIR
References:
citation: Badawy A, Sultan SM, Marzouk A, El-Sherif E. Thulium laser en bloc resection versus conventional transurethral resection of urinary bladder tumor: A comparative prospective study. Urol Ann. 2023 Jan-Mar;15(1):88-94. doi: 10.4103/ua.ua_59_22. Epub 2022 Nov 8.