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

NCT ID: NCT06818799

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-13
• Study Completion Date: 2024-12-10

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.

Conditions

Bladder Transitional Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thulium laser "TmLRBT"

Participants recieved thulium laser en-bloc resection of bladder mass

Group Type: EXPERIMENTAL

Thulium laser en-bloc resection of bladder mass

Intervention Type: PROCEDURE

En-bloc laser technique

Trans-Urethral resection "TURBT"

Participants recieved trans-urethral en-bloc resection of bladder mass

Group Type: ACTIVE_COMPARATOR

Trans-urethral en-bloc resection of bladder mass

Intervention Type: PROCEDURE

En-bloc technique

Interventions

Thulium laser en-bloc resection of bladder mass

En-bloc laser technique

Intervention Type: PROCEDURE

Trans-urethral en-bloc resection of bladder mass

En-bloc technique

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: collaborator

Maadi Military Hospital

OTHER_GOV

Sponsor Role: collaborator

Helwan University

OTHER

Sponsor Role: lead

Responsible Party

Samuel Fayek Tawfeles Ebskharoun

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tarek AM Salem, MD

Role: STUDY_CHAIR

Tarek Abdel magied Salem

Locations

Helwan university

Helwan, Cairo Governorate, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 37006212 (View on PubMed)

Other Identifiers

82-2023

Identifier Type: -

Identifier Source: org_study_id