Bladder Transitional Cell CarcinomaNCT06818799
Thulium Laser En-bloc Resection of Primary Non-muscle Invasive Bladder Cancer
A study testing Thulium laser en-bloc resection of bladder mass and Trans-urethral en-bloc resection of bladder mass in people with Bladder Transitional Cell Carcinoma, run by Helwan University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Bladder Transitional Cell Carcinoma
- What is being tested?
- Thulium laser en-bloc resection of bladder mass and Trans-urethral en-bloc resection of bladder mass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Aug 2023to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read more
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.
Read the 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
- Being tested
- Thulium laser en-bloc resection of bladder mass, Trans-urethral en-bloc resection of bladder mass
- Keywords
- Thulium laser resection of bladder mass, Trans-urethral resection of bladder mass, Non muscle-invasive bladder cancer
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thulium laser en-bloc resection of bladder massProcedure or surgery
En-bloc laser technique
Trans-urethral en-bloc resection of bladder massProcedure or surgery
En-bloc technique
| Study group | Role | What they receive |
|---|---|---|
| Thulium laser "TmLRBT" | Experimental | Participants recieved thulium laser en-bloc resection of bladder mass Receives: 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 Receives: Procedure: Trans-urethral en-bloc resection of bladder mass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival rate
Number of participants with recurrence free survival during scheduled follow up protocol according to European association of urology guidelines
Measured: 12 months
Local recurrence rate
Number of participants with absence of local recurrence on the site of resection during follow up cystoscopy protocol
Measured: 12 months
Secondary outcomes (1)
Peri-operative complications
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
Measured: Intra operative to 1 week post operative duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start13 Aug 2023
- Primary completion15 Nov 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bladder Transitional Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University, Maadi Military Hospital
- Responsible party
- Principal investigator, Samuel Fayek Tawfeles Ebskharoun, Helwan University
- Investigators
- Tarek AM Salem, MD, Study chair, Tarek Abdel magied Salem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818799
- Sponsor's protocol ID
- 82-2023
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37006212Zaza MM, ElAzab ME, Ebskharoun SF, Salem TAM, Ali MH, Mousa W. Evaluation of thulium laser endoscopic en bloc resection versus conventional trans-urethral en bloc resection of primary non-muscle invasive bladder cancer: a randomized controlled trial. Int Urol Nephrol. 2026 Sep 22. doi: 10.1007/s11255-026-05390-z. Online ahead of print.
PubMed 42771231
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Thulium Laser Endoscopic En-bloc Resection Versus Conventional Trans-urethral En-bloc Resection of Primary Non-muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT06818799
- Acronym / sponsor ID
- 82-2023
- Conditions
- Bladder Transitional Cell Carcinoma
- Keywords
- Thulium laser resection of bladder mass, Trans-urethral resection of bladder mass, Non muscle-invasive bladder cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Collaborators
- Ain Shams University, Maadi Military Hospital
- Study start
- 13 Aug 2023 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thulium laser "TmLRBT" | Experimental | Procedure: Thulium laser en-bloc resection of bladder massParticipants recieved thulium laser en-bloc resection of bladder mass |
| Trans-Urethral resection "TURBT" | Active comparator | Procedure: Trans-urethral en-bloc resection of bladder massParticipants recieved trans-urethral en-bloc resection of bladder mass |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thulium laser en-bloc resection of bladder massEn-bloc laser technique | Procedure or surgery | Thulium laser "TmLRBT" |
| Trans-urethral en-bloc resection of bladder massEn-bloc technique | Procedure or surgery | Trans-Urethral resection "TURBT" |
Primary outcome
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
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
1 secondary outcome
Peri-operative complications
Time frame: Intra operative to 1 week post operative duration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Background: PubMed 37006212Badawy 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.
- Derived from this study: PubMed 42771231Zaza MM, ElAzab ME, Ebskharoun SF, Salem TAM, Ali MH, Mousa W. Evaluation of thulium laser endoscopic en bloc resection versus conventional trans-urethral en bloc resection of primary non-muscle invasive bladder cancer: a randomized controlled trial. Int Urol Nephrol. 2026 Sep 22. doi: 10.1007/s11255-026-05390-z. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek AM Salem, MD study chair
Tarek Abdel magied Salem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thulium laser en-bloc resection of bladder mass and Trans-urethral en-bloc resection of bladder mass in people with Bladder Transitional Cell Carcinoma, run by Helwan University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence free survival rate (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06818799, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.