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

NCT06818799 | Completed DMC

• 1 other identifier: 82-2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Transitional Cell Carcinoma

Keywords

Thulium laser resection of bladder mass; Trans-urethral resection of bladder mass; Non muscle-invasive bladder cancer

Outcome Measures

Primary Outcomes (2)

• Recurrence free survival rate

  Number of participants with recurrence free survival during scheduled follow up protocol according to European association of urology guidelines

  12 months

• Local recurrence rate

  Number of participants with absence of local recurrence on the site of resection during follow up cystoscopy protocol

  12 months

Secondary Outcomes (1)

• Peri-operative complications

  Intra operative to 1 week post operative duration

Study Arms (2)

Thulium laser "TmLRBT"

EXPERIMENTAL

Participants recieved thulium laser en-bloc resection of bladder mass

Procedure: Thulium laser en-bloc resection of bladder mass

Trans-Urethral resection "TURBT"

ACTIVE COMPARATOR

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

Procedure: Trans-urethral en-bloc resection of bladder mass

Interventions

Thulium laser en-bloc resection of bladder mass PROCEDURE

En-bloc laser technique

Thulium laser "TmLRBT"

Trans-urethral en-bloc resection of bladder mass PROCEDURE

En-bloc technique

Trans-Urethral resection "TURBT"

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helwan University: lead
• Ain Shams University: collaborator
• Maadi Military Hospital: collaborator

Study Sites (1)

Helwan university

Helwan, Cairo Governorate, Egypt

Location

Related Publications (1)

• 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.

  PMID: 37006212 BACKGROUND

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Tarek AM Salem, MD

  Tarek Abdel magied Salem

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 10, 2025
• Study Start: August 13, 2023
• Primary Completion: November 15, 2024
• Study Completion: December 10, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)