En Bloc Bladder Tumor Resection: Prospective Randomized Study

Launched by FUNDACIO PUIGVERT · Jan 13, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new surgical technique called en bloc resection for treating bladder cancer, specifically urothelial carcinoma. This method aims to improve the quality of tissue samples for better diagnosis, reduce complications after surgery, and lower the chances of the cancer coming back. Researchers want to compare en bloc resection using different energy sources (like monopolar, bipolar, and laser) with the traditional method of tumor removal to see which is more effective and safer.

To participate in this trial, patients should have small bladder tumors (3 cm or less) that are either single or up to three in number. However, those with larger tumors or signs that the cancer may have spread to other parts of the body are not eligible. Participants will be randomly assigned to either the new en bloc method or the standard procedure. They'll receive detailed information about the study and can choose to opt out at any time without affecting their care. The trial will follow patients for at least five years to monitor their health and any signs of cancer recurrence.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Unifocal primary or recurrent bladder cancer with size less or equal than 3 cm
• • Multifocal primary or recurrent bladder cancer less or equal than 3 lesions and with size less or equal than 3 cm
• Exclusion Criteria:
• • Evidence of \> 3 tumors or \> 3 cm
• • Computed tomography/cystoscopy suspect of muscle-invasive bladder cancer (cT2 or higher)
• • Computed tomography/magnetic resonance evidence of distant metastases