Chairman, Dept of Urology RAMBAM HealthCare Campus
Introduction: Initial treatment for Non-Muscle Invasive Bladder Cancer (NMIBC) mostly remains unchanged in recent decades. Utilizing cryotherapy with CO2 is commonly used to treat superficial papillary lesions of the skin for many years. Recently, we have proven its potential in treating urinary epithelial lesions in an animal model. In this study we present our preliminary phase 1 clinical experience and results in treating low grade papillary lesions of the bladder with cryoablation. Methods: Following local IRB and Ministry of Health approval, 10 patients with up to 3 papillary lesions and a maximum of 10 mm in size were recruited. Exclusion criteria included previous high-grade disease and/or positive cytology. Following an initial routine cystoscopy, the bladder irrigation medium was replaced with CO2 insufflation, and each lesion was treated with 2 cycles of direct spraying of liquid CO2. Each cycle lasted 15 seconds, with 10 seconds of thawing between the treatment cycles. Follow-up cystoscopy and mandatory treatment site biopsy were performed 4-6 weeks after treatment. Routine surveillance with office cystoscopy was performed every 3 months for 1 year thereafter. Results: 8 men and 2 women were included (age 57—89 years). Overall, 14 lesions were treated. No complications were noted during treatment or during follow-up (range 2-14 months). Pathological analysis of the treatment site 4-6 weeks after treatment detected residual low grade TCC only in the very first patient, attributed to suboptimal lesion freezing due to our initial learning curve. The other 13/14 biopsy sites were negative for cancer (93%). Conclusions: Initial results of cryotherapy utilizing CO2 spraying for small low grade NMIBC is safe and feasible. Pathological analysis confirms efficacy in tumor eradication. This novel treatment may be used as an office procedure and therefore, after further validation studies, offers a potential paradigm shift in the treatment of NMIBC. SOURCE OF Funding: Biotechnological Incubator Trendlines, Misgav, Israel
