Safety Analysis and Oncological Outcomes in HoLERT vs TURBT

Launched by INSTITUTO DO CANCER DO ESTADO DE SÃO PAULO · Apr 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new method for removing large bladder tumors, specifically those larger than 3 cm, using a laser technique called Holmium Laser En Bloc Resection (HoLERT). This method aims to improve the way tumors are removed, potentially leading to fewer complications and a lower chance of the cancer coming back compared to the traditional method known as Transurethral Resection of Bladder Tumor (TURBT). The study focuses on patients with bladder cancer who do not show signs of more advanced disease, and it aims to provide better tissue samples for analysis, which can help in understanding the cancer better.

To be eligible for this trial, participants must be between 18 and 80 years old, have a bladder tumor larger than 3 cm, and must not have signs of muscle-invasive or advanced bladder cancer. They should be in good health to undergo surgery and be able to give informed consent. If you join the study, you can expect to have surgery using the laser technique, and your progress will be monitored to see how well this method works in improving patient outcomes. It's important to know that certain conditions and previous treatments might exclude someone from participating, so discussing eligibility with healthcare providers is key.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • Previous diagnosis of muscle-invasive bladder cancer;
• • Tumor's Invasive aspect (T2 or more) on image (US, TC or RNM);
• • Previous TURBT in the last 5 years;
• • Urethral stenosis;
• • Previous intra-vesical os systemic chemotherapy or radiotherapy;
• • Previous treatment with intravesical BCG
• • No clinical conditions for regional or general anesthesia;
• • Any other significant disease or disorder which, in the opinion of the investigator may either put the participant at risk because of trial participation or may influence the trial result, or the participant's ability ti participate in the trial.