Safety Analysis and Oncological Outcomes in Endoscopic Bladder Tumor Resection With Laser Holmium Compared With Transurethral Resection: a Prospective and Randomized Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Bladder urothelial cancer is the second most common urologic tumor and represents a worldwide public health problem. Most cases are diagnosed as non-muscle invasive tumors, and can be treated with transurethral resection of bladder tumor (TURBT). However, the electrical energy-based TURBT fragments the tumor, burning it to its own muscular layer leading to artifacts that may spoil the histopathological analysis, resulting in understaging after the first TURBT ranging from 30-64%, depending on the presence of detrusor muscle. Modern laser technologies have been emerging as an alternative to classical TURB using en bloc tumor resection technique (ERBT). Therefore, the laser is applied on tumor's pedicle to resect the whole and intact tumor without fragmentation or fulguration as occurs in TURBT. The purpose of using laser if to improve the resection quality, decrease intra and perioperative complications, avoid re-TURBT and reduce recurrence rates at the resection site and in distant sites. Thus, the purpose of this study is to evaluate Laser Holmium use for large tumors resection (\>3cm), reducing complications, costs, and the need for new approaches, and improving the muscle layers samples.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Patients aged between 18 and 80 years old;

• Presence of bladder tumor \> 3cm without signals of MIBC or advanced disease (US, CT scan or MRI 3 months before surgery)

• Able to understand and willing to sign a written informed consent document

• Satisfactory clinical pre operatory conditions for surgery with regional or general anesthesia.

Locations
Other Locations
Brazil
Instituto do Cancer do Estado de São Paulo (ICESP)
RECRUITING
São Paulo
Contact Information
Primary
Alexandre Iscaife, MD, PhD
alexandre.iscaife@hc.fm.usp.br
+5511976280082
Time Frame
Start Date: 2020-12-10
Estimated Completion Date: 2025-12
Participants
Target number of participants: 100
Treatments
Experimental: Holmium Laser En-bloc Resection of Bladder Tumors (HoLERBT) arm
Patients randomized to HoLERBT group will have their tumor resected using the Megapulse 70w (Richard Wolf).
Active_comparator: Control arm
Patients randomized to control arm will undergo a monopolar transurethral resection of bladder tumor.
Related Therapeutic Areas
Sponsors
Leads: Instituto do Cancer do Estado de São Paulo

This content was sourced from clinicaltrials.gov

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