- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02555163
Laser En Bloc Resection Of Bladder Tumor (HoLERBT) VS. Conventional Transurethral Resection Of Bladder Tumors (cTURBT) (HoLERBT)
Holmium (Ho: YAG) Laser En Bloc Resection Of Bladder Tumor (HoLERBT) Versus Conventional Transurethral Resection Of Bladder Tumors (cTURBT): A Prospective Randomized Controlled Trial
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Aldakahlia
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Mansoura, Aldakahlia, Egypt, 35516
- Urology and Nprhology Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients diagnosed at the out-patient cystoscopy with papillary bladder tumour will be legible for inclusion
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HoLERBT
Holmium (Ho: YAG) Laser En Bloc Resection Of Bladder Tumor
|
Using holmium laser, the tumour will be removed as one piece from its base working underneath the muscle layer
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Active Comparator: cTURBT
Conventional Transurethral Resection Of Bladder Tumors
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using the conventional electrocautery device with the cutting hot loop the tumor will be removed in pieces
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
residual disease at re-staging transurethral bladder biopsy
Time Frame: 4 weeks after primary procedure
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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
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4 weeks after primary procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
periprocedure complications
Time Frame: 2 days
|
Modified Clavien scale will be used for reporting and comparison of periprocedure complications
|
2 days
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recurrence free survival
Time Frame: 1 year
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Number of patients surviving for one year without tumor recurrence will be counted and compared
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ahmed M Elshal, MD, Mansoura urology and nephrology center, Mansoura University, Egypt
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MD.15.165.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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