Bladder Cancer Clinical Trial
— HoLERBTOfficial 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
Verified date | September 2020 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | September 2019 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Urology and Nprhology Center | Mansoura | Aldakahlia |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 4 weeks after primary procedure | |
Secondary | periprocedure complications | Modified Clavien scale will be used for reporting and comparison of periprocedure complications | 2 days | |
Secondary | recurrence free survival | Number of patients surviving for one year without tumor recurrence will be counted and compared | 1 year |
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