Thulium Laser En-bloc Resection of Primary Non-muscle Invasive Bladder Cancer

Not Applicable

Completed

• Conditions: Bladder Transitional Cell Carcinoma

• Registration Number: NCT06818799
• Lead Sponsor: Helwan University

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.

Study Timeline

• Study Start: 2023-08-13
• Primary Completion: 2024-11-15
• Study Completion: 2024-12-10
• Status Verified: 2025-02
• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-02-05
• Study First Posted: 2025-02-10
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recurrence free survival rate	12 months	Number of participants with recurrence free survival during scheduled follow up protocol according to European association of urology guidelines
Local recurrence rate	12 months	Number of participants with absence of local recurrence on the site of resection during follow up cystoscopy protocol

Secondary Outcome Measures

Name	Time	Method
Peri-operative complications	Intra operative to 1 week post operative duration	Number of participants developed peri operative complications regarding severity of bleeding ,number of paricipants developed bladder wall perforation , number of participants developed obturator jerk and severity of lower urinary tract symptoms

Trial Locations

Locations (1)

Helwan university; 🇪🇬 Helwan, Cairo, Egypt