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Laser En Bloc Resection Of Bladder Tumor (HoLERBT) VS. Conventional Transurethral Resection Of Bladder Tumors (cTURBT) (HoLERBT)

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ClinicalTrials.gov Identifier: NCT02555163
Recruitment Status : Active, not recruiting
First Posted : September 21, 2015
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Elshal, Mansoura University

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Device: HoLERBT Device: cTURBT Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : September 2015
Actual Primary Completion Date : September 2017
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: HoLERBT
Holmium (Ho: YAG) Laser En Bloc Resection Of Bladder Tumor
Device: HoLERBT
Using holmium laser, the tumour will be removed as one piece from its base working underneath the muscle layer

Active Comparator: cTURBT
Conventional Transurethral Resection Of Bladder Tumors
Device: cTURBT
using the conventional electrocautery device with the cutting hot loop the tumor will be removed in pieces




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. periprocedure complications [ Time Frame: 2 days ]
    Modified Clavien scale will be used for reporting and comparison of periprocedure complications

  2. recurrence free survival [ Time Frame: 1 year ]
    Number of patients surviving for one year without tumor recurrence will be counted and compared



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02555163


Locations
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Egypt
Urology and Nprhology Center
Mansoura, Aldakahlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
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Study Director: Ahmed M Elshal, MD Mansoura urology and nephrology center, Mansoura University, Egypt

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Responsible Party: Ahmed Elshal, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT02555163     History of Changes
Other Study ID Numbers: Mans17-9-2015
First Posted: September 21, 2015    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ahmed Elshal, Mansoura University:
bladder cancer, laser

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases