NCT05833997

Safety Analysis and Oncological Outcomes in HoLERT vs TURBT

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Instituto do Cancer do Estado de São Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-institution, randomized, single-blinded, prospective, controlled study, with 2 groups - 50 patients in Holmium Laser En-bloc Resection of Bladder Tumors (HoLERBT) arm and 50 patients in TURBT arm. All the patients will undergo a new procedure between 30-60 days after the first one (monopolar re-TURBT). The laser group will be operated by an experienced surgeon with more than 50 cases of prostate resection. The monopolar TURBT group will be operated by institutions´s surgeons assistants, urologists with more than 2 years of experience in the area and more than 50 surgeries performed. Pathological samples will be analyzed in the FMUSP Urology Laboratory by a pathologist with huge experience in analysis of bladder tumors.

Conditions

• Bladder Urothelial Carcinoma
• Bladder Cancer

Interventions

Type	Name	Description
PROCEDURE	Monopolar Transurethral resection of bladder tumor	Patients randomized to Monopolar TURBT will be operated using a 26F continuous-flow resectoscope sheaths and a single-pole working element to exclusive use of the resection. The power will be set to cut in 80w and 60w. The technique that will be performed will be the classic endoscopic resection from the top of the tumor until reaching the base, taking a sample from the base of the lesion (muscle layer). Fragments will be removed through an Ellik evacuator, and the solution used will be 3% glycine. After the procedure, the patient will will be catheterized with a silicon catheter number 22F with three ways and continuous irrigation. After 30-60 days of the first procedure, all patients diagnosed with a lamina propria invasion in the uro-pathology analysis (T1) will be submitted to a new monopolar TURBT.
PROCEDURE	Holmium Laser resection of bladder tumor (HoLEBT)	It will be used a 24-26F continuous-flow resectoscope sheath with a specific working element to use with a 600µm fiber to Laser Holmium. Patients will be operated with the Megapulse 70w (Richard Wolf) and laser will be set to deliver the energy of 0,5J and 30-40Hz frequency, 15-20W of final energy. The solution used will be 0,9% saline solution. The resection will start from the base of the lesion, reaching the muscle layer to obtain a sample and resection of the whole tumor, without fragmentation. After this, the morcellation will be performed in the apex of tumor sparing the base with a long nephroscope, and the patient will will be catheterized with a silicon catheter number 22F with three ways and continuous irrigation. The morcellated product will be sent to the pathology lab for detailed analysis.

Timeline

• Start date: 2020-12-10
• Primary completion: 2023-12-01
• Completion: 2025-12-01
• First posted: 2023-04-27
• Last updated: 2023-04-27

Locations

1 site across 1 country: Brazil