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

February 10, 2025 updated by: Samuel Fayek Tawfeles Ebskharoun, Helwan University

Evaluation of Thulium Laser Endoscopic En-bloc Resection Versus Conventional Trans-urethral En-bloc Resection of Primary Non-muscle Invasive Bladder Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo
      • Helwan, Cairo, Egypt
        • Helwan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thulium laser "TmLRBT"
Participants recieved thulium laser en-bloc resection of bladder mass
Procedure: Thulium laser en-bloc resection of bladder mass
En-bloc laser technique
Active Comparator: Trans-Urethral resection "TURBT"
Participants recieved trans-urethral en-bloc resection of bladder mass
Procedure: Trans-urethral en-bloc resection of bladder mass
En-bloc technique

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri-operative complications
Time Frame: 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
Intra operative to 1 week post operative duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helwan University

Collaborators

Ain Shams University
Maadi Military Hospital

Investigators

  • Study Chair: Tarek AM Salem, MD, Tarek Abdel magied Salem

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2023

Primary Completion (Actual)

November 15, 2024

Study Completion (Actual)

December 10, 2024

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 82-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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