Treatment of chronic radiation proctitis with cryoablation

Background: Chronic radiation proctitis (CRP) is a common problem in patients receiving pelvic radiation. Current therapies have the potential for deep tissue injury with ulcerations, perforation, and fistula formation. Cryospray ablation therapy offers superficial ablation of mucosa and is a potential method to endoscopically treat CRP safely and effectively. Objective: To determine tolerability of and response to cryotherapy in patients with radiation proctitis. Design: Prospective case-series pilot study. Setting: Baylor College of Medicine, Michael E. DeBakey Medical Center, Houston, Texas. Patients: Ten patients were prospectively recruited with chronic hemorrhagic radiation proctitis. Interventions: Endoscopic cryoablation of CRP. Main Outcome Measurements: Symptom severity of CRP was obtained by using the Radiation Proctitis Severity Assessment Scale (RPSAS). Endoscopic assessment was obtained using the rectal telangiectasia density grade. The primary endpoint of the study was endoscopic improvement of CRP based on the change in rectal telangiectasia density at 3-month follow-up. Secondary endpoints included symptomatic improvement based on RPSAS and adverse events at 3 months. Results: Ten patients with hemorrhagic radiation proctitis were treated with endoscopic cryoablation. Endoscopic severity improved as measured by rectal telangiectasia density from 2.7 to 1.7 (P = .004). Overall subjective clinical scores improved as determined by the Radiation Proctitis Severity Assessment Scale from 27.7 to 13.6 (P = .003). Endoscopic improvement correlated with symptom improvement. Limitations: Nonpowered case series pilot study. Conclusions: Cryoablation improved clinical and endoscopic indices in CRP. Further controlled studies are needed to identify the safety and efficacy of cryoablation for CRP.