Bladder CancerNCT04110483
Thulium Fiber Laser En-bloc Resection vs Conventional Transurethral Resection of Non-muscle-invasive Bladder Cancer
A study testing Thulium fiber laser en-bloc resection of non-muscle-invasive bladder cancer and Transurethral resection of non-muscle-invasive bladder cancer in people with Bladder Cancer, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
Ongoing efforts aim at overcoming the challenges of conventional transurethral resection of bladder tumor (TURBT) such as the high recurrence rate, difficulty of pathologic interpretation and complications including wall injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Thulium fiber laser en-bloc resection of non-muscle-invasive bladder cancer and Transurethral resection of non-muscle-invasive bladder cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2015to 31 Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary Ta or T1 bladder cancer (NMIBC)
Who cannot join
- Pure carcinoma in situ
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Short-term Oncological Outcomes of Thulium Fiber Laser En-bloc Resection of Non-muscle-invasive Bladder Cancer
Ongoing efforts aim at overcoming the challenges of conventional transurethral resection of bladder tumor (TURBT) such as the high recurrence rate, difficulty of pathologic interpretation and complications including wall injury. Possible advantages may have en bloc resection of bladder tumor which was previously shown to be effective and safe technique. Use of novel thulium-fiber laser may also provide additional safety and efficacy of the resection.
Objective. To prospective assess the safety and efficacy of Thulium-fiber en bloc resection of bladder tumor (Tm-fiber-ERBT) compared to TURBT.
Read the detailed description
En bloc resection of bladder tumor (ERBT) was first employed by Kawada T. et al. in 1997. The technique showed promising results in terms of safety and tumor staging. Development of laser surgery and emergence of the holmium (Ho:YAG) and later thulium (Tm:YAG) lasers in the 1990s enabled laser ERBT with subsequent studies demonstrating high efficacy and safety of the new techniques. Ho:YAG and Tm:YAG ERBT have distinct advantages over conventional TURBT such as the complete absence of the obturator nerve reflex and hence, lower risks of perforation or bleeding as well as a higher quality specimens for pathologic examination, due to lack of the cautery effect. Recently, a new type of thulium laser was developed - that allows to decrease the penetration depth less than 0.15 mm, which is two times less than that of Tm:YAG. Another advantage is the decreased carbonization compared to Tm:YAG due to better water absorption of laser energy. All these aspects make Tm:YAG a precise tool that may improve the resection quality resulting in better management. Data on laser ERBT of NMIBC with Tm:YAG is limited and that on Tm-fiber laser ERBT is absent altogether. The investigators hypothesized that Tm-fiber laser ERBT would result in a lower probability of adverse events and better recurrence-free survival compared to conventional TURBT.
- Conditions
- Bladder Cancer
- Being tested
- Thulium fiber laser en-bloc resection of non-muscle-invasive bladder cancer, Transurethral resection of non-muscle-invasive bladder cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thulium fiber laser en-bloc resection of non-muscle-invasive bladder cancerProcedure or surgery
After cystoscopy and determining tumor topography, a circumferential incision around the tumor is made in the visually intact bladder mucosa (approximately 10 mm from the edges of the tumor). It allows for accurate morphological evaluation of the surgical margin. After that, the incision is continued deeper into the muscular layer. Having identified the layer, the surgeon resects the base of the tumor with the muscular layer using traction and incisions of the muscle fibers. Making incisions in the muscular layer requires precision, a full bladder and adequate guidance with visualization techniques. Traction may be employed with the help of the tip of the resectoscope or working element. After complete tumor resection, local hemostasis was performed.
Transurethral resection of non-muscle-invasive bladder cancerProcedure or surgery
After cystoscopy and determining tumor topography, a step-by-step resection of a tumor is done. Firstly, visible tumor is resected, then resection continues to the apparently normal mucosa on the border of the tumor, than resection of the muscle layer at the base of the tumor is performed until normal muscle fibers are visible.
| Study group | Role | What they receive |
|---|---|---|
| TURBT | Active comparator | A step-by-step resection of a tumor. Firstly, visible tumor is resected, then resection continues to the apparently normal mucosa on the border of the tumor, than resection of the muscle layer at the base of the tumor is performed until normal muscle fibers are visible. Receives: Procedure: Transurethral resection of non-muscle-invasive bladder cancer |
| Tm-fiber ERBT | Experimental | A circumferential incision around the tumor is made in the visually intact bladder mucosa. After that, the incision is continued deeper into the muscular layer. Than the surgeon resects the base of the tumor with the muscular layer using traction and incisions of the muscle fibers. Receives: Procedure: Thulium fiber laser en-bloc resection of non-muscle-invasive bladder cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival rate
Absence of cancer at the site of previous resection on histological examination after re-biopsy
Measured: 3 month
Secondary outcomes (2)
Detrusor presence in the specimen
The presence of muscle fibers in specimens on histological investigation
Measured: 1 day after the surgery
Complications
Rate of postoperative complications, their severity according Clavien-Dindo score
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start1 Jan 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University
- Investigators
- Dmitry Enikeev, M.D., Ph.D., Principal investigator, Sechenov University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110483
- Sponsor's protocol ID
- Sechenov-ERBT-16
- Status last verified
- Feb 2020
- First submitted
- 25 Sep 2019
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Short-term Oncological Outcomes of Thulium Fiber Laser En-bloc Resection of Non-muscle-invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT04110483
- Acronym / sponsor ID
- Sechenov-ERBT-16
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 1 Oct 2019 (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.
Ongoing efforts aim at overcoming the challenges of conventional transurethral resection of bladder tumor (TURBT) such as the high recurrence rate, difficulty of pathologic interpretation and complications including wall injury. Possible advantages may have en bloc resection of bladder tumor which was previously shown to be effective and safe technique. Use of novel thulium-fiber laser may also provide additional safety and efficacy of the resection.
Objective. To prospective assess the safety and efficacy of Thulium-fiber en bloc resection of bladder tumor (Tm-fiber-ERBT) compared to TURBT.
Detailed description
En bloc resection of bladder tumor (ERBT) was first employed by Kawada T. et al. in 1997. The technique showed promising results in terms of safety and tumor staging. Development of laser surgery and emergence of the holmium (Ho:YAG) and later thulium (Tm:YAG) lasers in the 1990s enabled laser ERBT with subsequent studies demonstrating high efficacy and safety of the new techniques. Ho:YAG and Tm:YAG ERBT have distinct advantages over conventional TURBT such as the complete absence of the obturator nerve reflex and hence, lower risks of perforation or bleeding as well as a higher quality specimens for pathologic examination, due to lack of the cautery effect. Recently, a new type of thulium laser was developed - that allows to decrease the penetration depth less than 0.15 mm, which is two times less than that of Tm:YAG. Another advantage is the decreased carbonization compared to Tm:YAG due to better water absorption of laser energy. All these aspects make Tm:YAG a precise tool that may improve the resection quality resulting in better management. Data on laser ERBT of NMIBC with Tm:YAG is limited and that on Tm-fiber laser ERBT is absent altogether. The investigators hypothesized that Tm-fiber laser ERBT would result in a lower probability of adverse events and better recurrence-free survival compared to conventional TURBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TURBT | Active comparator | Procedure: Transurethral resection of non-muscle-invasive bladder cancerA step-by-step resection of a tumor. Firstly, visible tumor is resected, then resection continues to the apparently normal mucosa on the border of the tumor, than resection of the muscle layer at the base of the tumor is performed until normal muscle fibers are visible. |
| Tm-fiber ERBT | Experimental | Procedure: Thulium fiber laser en-bloc resection of non-muscle-invasive bladder cancerA circumferential incision around the tumor is made in the visually intact bladder mucosa. After that, the incision is continued deeper into the muscular layer. Than the surgeon resects the base of the tumor with the muscular layer using traction and incisions of the muscle fibers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary Ta or T1 bladder cancer (NMIBC)
Key exclusion criteria (1 listed)
- Pure carcinoma in situ
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 fiber laser en-bloc resection of non-muscle-invasive bladder cancerAfter cystoscopy and determining tumor topography, a circumferential incision around the tumor is made in the visually intact bladder mucosa (approximately 10 mm from the edges of the tumor). It allows for accurate morphological evaluation of the surgical margin. After that, the incision is continued deeper into the muscular layer. Having identified the layer, the surgeon resects the base of the tumor with the muscular layer using traction and incisions of the muscle fibers. Making incisions in the muscular layer requires precision, a full bladder and adequate guidance with visualization techniques. Traction may be employed with the help of the tip of the resectoscope or working element. After complete tumor resection, local hemostasis was performed. | Procedure or surgery | Tm-fiber ERBT |
| Transurethral resection of non-muscle-invasive bladder cancerAfter cystoscopy and determining tumor topography, a step-by-step resection of a tumor is done. Firstly, visible tumor is resected, then resection continues to the apparently normal mucosa on the border of the tumor, than resection of the muscle layer at the base of the tumor is performed until normal muscle fibers are visible. | Procedure or surgery | TURBT |
Primary outcome
Recurrence-free survival rate
Time frame: 3 month
Absence of cancer at the site of previous resection on histological examination after re-biopsy
2 secondary outcomes
Detrusor presence in the specimen
Time frame: 1 day after the surgery
Complications
Time frame: up to 1 year
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 18 Feb 2020.
- 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.
Dmitry Enikeev, M.D., Ph.D. principal investigator
Sechenov University
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 fiber laser en-bloc resection of non-muscle-invasive bladder cancer and Transurethral resection of non-muscle-invasive bladder cancer in people with Bladder Cancer, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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 1 inclusion and 1 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 18 Feb 2020. 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 Russia. 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: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2020.