Laser En Bloc Resection Of Bladder Tumor (HoLERBT) VS. Conventional Transurethral Resection Of Bladder Tumors (cTURBT) (HoLERBT)
Primary Purpose
Bladder Cancer
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
HoLERBT
cTURBT
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring bladder cancer, laser
Eligibility Criteria
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
Sites / Locations
- Urology and Nprhology Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HoLERBT
cTURBT
Arm Description
Holmium (Ho: YAG) Laser En Bloc Resection Of Bladder Tumor
Conventional Transurethral Resection Of Bladder Tumors
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
periprocedure complications
Modified Clavien scale will be used for reporting and comparison of periprocedure complications
recurrence free survival
Number of patients surviving for one year without tumor recurrence will be counted and compared
Full Information
NCT ID
NCT02555163
First Posted
September 16, 2015
Last Updated
September 16, 2020
Sponsor
Mansoura University
1. Study Identification
Unique Protocol Identification Number
NCT02555163
Brief Title
Laser En Bloc Resection Of Bladder Tumor (HoLERBT) VS. Conventional Transurethral Resection Of Bladder Tumors (cTURBT)
Acronym
HoLERBT
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
bladder cancer, laser
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HoLERBT
Arm Type
Experimental
Arm Description
Holmium (Ho: YAG) Laser En Bloc Resection Of Bladder Tumor
Arm Title
cTURBT
Arm Type
Active Comparator
Arm Description
Conventional Transurethral Resection Of Bladder Tumors
Intervention Type
Device
Intervention Name(s)
HoLERBT
Intervention Description
Using holmium laser, the tumour will be removed as one piece from its base working underneath the muscle layer
Intervention Type
Device
Intervention Name(s)
cTURBT
Intervention Description
using the conventional electrocautery device with the cutting hot loop the tumor will be removed in pieces
Primary Outcome Measure Information:
Title
residual disease at re-staging transurethral bladder biopsy
Description
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
Time Frame
4 weeks after primary procedure
Secondary Outcome Measure Information:
Title
periprocedure complications
Description
Modified Clavien scale will be used for reporting and comparison of periprocedure complications
Time Frame
2 days
Title
recurrence free survival
Description
Number of patients surviving for one year without tumor recurrence will be counted and compared
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Elshal, MD
Organizational Affiliation
Mansoura urology and nephrology center, Mansoura University, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Urology and Nprhology Center
City
Mansoura
State/Province
Aldakahlia
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33386289
Citation
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.
Results Reference
derived
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Laser En Bloc Resection Of Bladder Tumor (HoLERBT) VS. Conventional Transurethral Resection Of Bladder Tumors (cTURBT)
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