Bladder CancerHoLERBTNCT02555163
Laser En Bloc Resection Of Bladder Tumor (HoLERBT) VS. Conventional Transurethral Resection Of Bladder Tumors (cTURBT)
A study testing HoLERBT and cTURBT in people with Bladder Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
Randomized clinical trial aiming to assess Holmium Laser En Bloc Resection Of Bladder Tumor (HoLERBT) in comparison with Conventional Transurethral Resection Of Bladder Tumors (cTURBT) in tumor histopathological staging quality, detrusor muscle sampling in biopsy, completeness of tumor resection and peri procedure… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- HoLERBT and cTURBT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2015to Sep 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed at the out-patient cystoscopy with papillary bladder tumour will be legible for inclusion
Who cannot join
- Tumor criteria
- Non papillary gross features of the tumor
- Anteriorly located tumor
- Patients criteria
- Poor performance status
- History of BCG sepsis
- History of bladder irradiation
- Contracted bladder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Holmium (Ho: YAG) Laser En Bloc Resection Of Bladder Tumor (HoLERBT) Versus Conventional Transurethral Resection Of Bladder Tumors (cTURBT): A Prospective Randomized Controlled Trial
Randomized clinical trial aiming to assess Holmium Laser En Bloc Resection Of Bladder Tumor (HoLERBT) in comparison with Conventional Transurethral Resection Of Bladder Tumors (cTURBT) in tumor histopathological staging quality, detrusor muscle sampling in biopsy, completeness of tumor resection and peri procedure complication.
Read the detailed description
Urothelial carcinoma of the bladder is the 2nd most common urological malignancy and it makes a growing healthcare problem worldwide.
The vast majority of newly diagnosed are non-muscle bladder cancers (NMIBC) which represents about 75% and can be treated with transurethral resection of bladder tumors (TURBT) so, correct initial staging is critical. The quality of TURBT strongly determines patient prognosis and overall treatment.
Conventional transurethral resection of bladder tumors (cTURBT) causes fragmentation, artifacts, thermal damages and tangential sections that might hamper histopathological evaluation.
The expert meeting at Davos of the European Association of Urology (EAU) section of Uro-Technology (ESUT) and the section of Uro-Oncology (ESOU) identified en bloc resections of bladder tumors (ERBT) using various energy sources or modified resection loops as a promising technique.
Laser therapy for the treatment of non muscle invasive bladder tumor (NMIBC) was first reported in the 1970s. Neodymium:YAG lasers were mainly used for tissue vaporization. Afterward, the introductions of en bloc resection methods have laser treatments for bladder cancer regains its popularity. The most commonly used are holmium (Ho:YAG) and thulium (Tm:YAG).
EBRBT overall complication rate of 0.7%, of which all complications had not been life-threatening. Compared conventional TURBT to HoLERBT, a significant reduction of obturator nerve reflex, related bladder perforations, peri- or postoperative bleeding was rare, reduction in bladder irrigation time in comparison with conventional TURB. Better histopathological results were with laser en bloc resection of bladder cancer by lowering of thermal damage The study will be conducted in a single tertiary centre at Urology and Nephrology Center in Mansoura, Egypt.
Eligible patient presented with papillary bladder tumor will be asked to participate in this study and will be provided with an informed consent form in line with Good Clinical Practise and the Declaration of Helsinki.
- Conditions
- Bladder Cancer
- Being tested
- HoLERBT, cTURBT
- Keywords
- bladder cancer, laser
- 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.
HoLERBTDevice
Using holmium laser, the tumour will be removed as one piece from its base working underneath the muscle layer
cTURBTDevice
using the conventional electrocautery device with the cutting hot loop the tumor will be removed in pieces
| Study group | Role | What they receive |
|---|---|---|
| HoLERBT | Experimental | Holmium (Ho: YAG) Laser En Bloc Resection Of Bladder Tumor Receives: Device: HoLERBT |
| cTURBT | Active comparator | Conventional Transurethral Resection Of Bladder Tumors Receives: Device: cTURBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
residual disease at re-staging transurethral bladder biopsy
Rebiopsy of the tumor base for detection of any residual disease at re staging TUR 4 weeks after primary procedure. Number of patients with residual disease at restaginf TUR will be counted in each arm and compared
Measured: 4 weeks after primary procedure
Secondary outcomes (2)
periprocedure complications
Modified Clavien scale will be used for reporting and comparison of periprocedure complications
Measured: 2 days
recurrence free survival
Number of patients surviving for one year without tumor recurrence will be counted and compared
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2017
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elshal, Mansoura University
- Investigators
- Ahmed M Elshal, MD, Study director, Mansoura urology and nephrology center, Mansoura University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555163
- Sponsor's protocol ID
- MD.15.165.
- Acronym
- HoLERBT
- Status last verified
- Sep 2020
- First submitted
- 16 Sep 2015
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Hashem A, Mosbah A, El-Tabey NA, Laymon M, Ibrahiem EH, Elhamid MA, Elshal AM. Holmium Laser En-bloc Resection Versus Conventional Transurethral Resection of Bladder Tumors for Treatment of Non-muscle-invasive Bladder Cancer: A Randomized Clinical Trial. Eur Urol Focus. 2021 Sep;7(5):1035-1043. doi: 10.1016/j.euf.2020.12.003. Epub 2020 Dec 30.
PubMed 33386289
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holmium (Ho: YAG) Laser En Bloc Resection Of Bladder Tumor (HoLERBT) Versus Conventional Transurethral Resection Of Bladder Tumors (cTURBT): A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02555163
- Acronym / sponsor ID
- HoLERBT / MD.15.165.
- Conditions
- Bladder Cancer
- Keywords
- bladder cancer, laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 21 Sep 2015 (estimated)
- 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.
Randomized clinical trial aiming to assess Holmium Laser En Bloc Resection Of Bladder Tumor (HoLERBT) in comparison with Conventional Transurethral Resection Of Bladder Tumors (cTURBT) in tumor histopathological staging quality, detrusor muscle sampling in biopsy, completeness of tumor resection and peri procedure complication.
Detailed description
Urothelial carcinoma of the bladder is the 2nd most common urological malignancy and it makes a growing healthcare problem worldwide.
The vast majority of newly diagnosed are non-muscle bladder cancers (NMIBC) which represents about 75% and can be treated with transurethral resection of bladder tumors (TURBT) so, correct initial staging is critical. The quality of TURBT strongly determines patient prognosis and overall treatment.
Conventional transurethral resection of bladder tumors (cTURBT) causes fragmentation, artifacts, thermal damages and tangential sections that might hamper histopathological evaluation.
The expert meeting at Davos of the European Association of Urology (EAU) section of Uro-Technology (ESUT) and the section of Uro-Oncology (ESOU) identified en bloc resections of bladder tumors (ERBT) using various energy sources or modified resection loops as a promising technique.
Laser therapy for the treatment of non muscle invasive bladder tumor (NMIBC) was first reported in the 1970s. Neodymium:YAG lasers were mainly used for tissue vaporization. Afterward, the introductions of en bloc resection methods have laser treatments for bladder cancer regains its popularity. The most commonly used are holmium (Ho:YAG) and thulium (Tm:YAG).
EBRBT overall complication rate of 0.7%, of which all complications had not been life-threatening. Compared conventional TURBT to HoLERBT, a significant reduction of obturator nerve reflex, related bladder perforations, peri- or postoperative bleeding was rare, reduction in bladder irrigation time in comparison with conventional TURB. Better histopathological results were with laser en bloc resection of bladder cancer by lowering of thermal damage The study will be conducted in a single tertiary centre at Urology and Nephrology Center in Mansoura, Egypt.
Eligible patient presented with papillary bladder tumor will be asked to participate in this study and will be provided with an informed consent form in line with Good Clinical Practise and the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HoLERBT | Experimental | Device: HoLERBTHolmium (Ho: YAG) Laser En Bloc Resection Of Bladder Tumor |
| cTURBT | Active comparator | Device: cTURBTConventional Transurethral Resection Of Bladder Tumors |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed at the out-patient cystoscopy with papillary bladder tumour will be legible for inclusion
Key exclusion criteria (8 listed)
- Tumor criteria
- Patients criteria
- Poor performance status
- History of BCG sepsis
- History of bladder irradiation
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 |
|---|---|---|
| HoLERBTUsing holmium laser, the tumour will be removed as one piece from its base working underneath the muscle layer | Device | HoLERBT |
| cTURBTusing the conventional electrocautery device with the cutting hot loop the tumor will be removed in pieces | Device | cTURBT |
Primary outcome
residual disease at re-staging transurethral bladder biopsy
Time frame: 4 weeks after primary procedure
Rebiopsy of the tumor base for detection of any residual disease at re staging TUR 4 weeks after primary procedure. Number of patients with residual disease at restaginf TUR will be counted in each arm and compared
2 secondary outcomes
periprocedure complications
Time frame: 2 days
recurrence free survival
Time frame: 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 Sep 2020.
- Derived from this study: PubMed 33386289Hashem A, Mosbah A, El-Tabey NA, Laymon M, Ibrahiem EH, Elhamid MA, Elshal AM. Holmium Laser En-bloc Resection Versus Conventional Transurethral Resection of Bladder Tumors for Treatment of Non-muscle-invasive Bladder Cancer: A Randomized Clinical Trial. Eur Urol Focus. 2021 Sep;7(5):1035-1043. doi: 10.1016/j.euf.2020.12.003. Epub 2020 Dec 30.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed M Elshal, MD study director
Mansoura urology and nephrology center, Mansoura University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HoLERBT and cTURBT in people with Bladder Cancer, run by Mansoura 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 1 inclusion and 8 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 Sep 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 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?
residual disease at re-staging transurethral bladder biopsy (time frame: 4 weeks after primary procedure). 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 NCT02555163, which also lists 1 linked publication.
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 Sep 2020.