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

NCT ID: NCT02555163

Last Updated: 2020-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2019-09-30

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HoLERBT

Holmium (Ho: YAG) Laser En Bloc Resection Of Bladder Tumor

Group Type: EXPERIMENTAL

HoLERBT

Intervention Type: DEVICE

Using holmium laser, the tumour will be removed as one piece from its base working underneath the muscle layer

cTURBT

Conventional Transurethral Resection Of Bladder Tumors

Group Type: ACTIVE_COMPARATOR

cTURBT

Intervention Type: DEVICE

using the conventional electrocautery device with the cutting hot loop the tumor will be removed in pieces

Interventions

HoLERBT

Using holmium laser, the tumour will be removed as one piece from its base working underneath the muscle layer

Intervention Type: DEVICE

cTURBT

using the conventional electrocautery device with the cutting hot loop the tumor will be removed in pieces

Intervention Type: DEVICE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Elshal

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed M Elshal, MD

Role: STUDY_DIRECTOR

Mansoura urology and nephrology center, Mansoura University, Egypt

Locations

Urology and Nprhology Center

Al Mansurah, Aldakahlia, Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 33386289 (View on PubMed)

Other Identifiers

MD.15.165.

Identifier Type: -

Identifier Source: org_study_id