Safety Analysis and Oncological Outcomes in HoLERT vs TURBT

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

December 10, 2020

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2025

Conditions
Bladder Urothelial CarcinomaBladder Cancer
Interventions
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."

Trial Locations (1)

Unknown

RECRUITING

Instituto do Cancer do Estado de São Paulo (ICESP), São Paulo

All Listed Sponsors
lead

Instituto do Cancer do Estado de São Paulo

OTHER