First proctological application of a noncontact nitrous oxide cryotherapy device treating nonmalignant intra- and perianal HPV-related lesions

BACKGROUND AND AIM: Anal human papillomavirus (HPV) infection can cause benign and precancerous intra- and perianal lesions. Multiple treatments, including liquid nitrogen cryotherapy, are available with varying efficacy, safety and logistic issues. Little consensus exists considering best clinical practice. This study aims to assess efficacy, safety, and practical applicability of a handheld, noncontact cryotherapy device using nitrous oxide to treat nonmalignant HPV-related intra- and perianal lesions. METHODS: A single-center exploratory, open-label proof of concept case series was performed followed by a prospective single-arm interventional study with standardized treatment protocol, conducted at the proctology clinic of the Ghent University Hospital (Belgium). Consecutive patients presenting with benign, intra-, and/or perianal HPV-related lesions were offered noncontact cryotherapy treatment. Primary endpoint was clinical remission, within 4 months of treatment. Secondary endpoints included 1 year recurrence rate and treatment-emergent adverse events. Practical applicability of the device was evaluated and technical properties were adjusted to maximize applicability in everyday ambulatory proctology practice. RESULTS: In total, 73 patients were treated. Clinical remission within 4 months was seen in 47/63 (74.6%). No major adverse events were noted and treatment was well tolerated. Compliance to the study protocol follow-up schedule was rather low in this patient population. CONCLUSIONS: This study is the first to describe this noncontact nitrous oxide cryotherapy device for treatment of intra- and perianal nonmalignant HPV-related lesions. Efficacy rates were high and treatment was well tolerated.