The Effect of Hyperthermic Intravesical Perfusion on the Risk of Intraoperative Implantation of Muscle-invasive Bladder Urothelial Carcinoma and Its Safety Analysis
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
To evaluate the effect of hyperthermic intravesical perfusion on the risk of intraoperative implantation of muscle-invasive bladder urothelial carcinoma and its safety.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Be willing and able to provide written informed consent for the trial.
• 18-75 years of age on day of signing informed consent.
• Have histologically confirmed muscle invasive disease of the urinary bladder.
• Histology must be urothelial carcinoma (transitional cell carcinoma) or urothelial carcinoma with mixed histology/features.
• Clinical stage II-III and Have a surgical evaluation that documents the plan for multimodality therapy with a consolidative radical cystectomy.
• Eastern Cooperative Oncology Group 0-1 and good organ function.
Locations
Other Locations
China
BR-PRG
RECRUITING
Zhengzhou
Contact Information
Primary
Huaqi Yin
yhq901212@163.com
+8613366621170
Time Frame
Start Date: 2022-06-06
Estimated Completion Date: 2025-12
Participants
Target number of participants: 40
Treatments
Experimental: The experimental group
Participants in the experimental group will be treated with hyperthermic intravesical perfusion before receiving radical cystectomy.
No_intervention: The control group
Participants in the control group will receive radical cystectomy alone.
Related Therapeutic Areas
Sponsors
Leads: Henan Cancer Hospital