Depth of Necrosis Using Different Ablation Techniques in Healthy Cervical Tissue

22 Background: Screening followed by treatment has been a key contributor to the reduction of cervical cancer in industrialized countries and is critical to reduce its burden in low-resource countries. Screening technologies that are appropriate for low-resource settings have advanced considerably; however, treatment technologies have lagged. Treatment methods that are used in developing countries must be low cost, effective, and adaptable for areas with limited infrastructure and health care providers. This study was performed to determine the depth of necrosis in cervical tissue achieved with three treatment devices: conventional cryotherapy with CO2, the CryoPen (CryoPen, Corpus Christi, TX) adapted for low-resource settings, and the thermocoagulator. Methods: One hundred twenty-five women who were scheduled for hysterectomy for indications other than cervical pathology were randomly assigned to one of five treatment arms: single-freeze arms and double-freeze arms for both conventional cryotherapy and the adapted CryoPen, and a single application of thermoablation at 100° C for 40 seconds. Treatment was administered 12 to 24 hours before hysterectomy. Depth of necrosis in cervical specimens was measured by pathologists who were blinded to the treatment modality. Results: A total of 119 women have been enrolled to date, and 114 specimens have been reviewed. Mean depth of necrosis is 5.1 mm (0.9 to 8.5 mm) for single-freeze cryotherapy, 5.6 mm (3.8 to 10.5 mm) for double-freeze cryotherapy, 4.9 mm (3.5 to 8.5 mm) for single-freeze adapted CryoPen; 4.5 mm (3.0 to 7.3 mm) for double-freeze adapted CryoPen, and 3.7 mm (1.9 to 5.5 mm) for the thermoablation ( Table 1 ). Conclusion: The depths of necrosis achieved with the three different ablation modalities are competitive and surpass the targeted depth of 3.5 mm established a priori. Results thus far have demonstrated that devices that are optimized for use in low-resource settings can be as effective as conventional cryotherapy in treating cervical intraepithelial neoplasia. [Table: see text] AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST Miriam Cremer Honoraria: Merck Speakers' Bureau: Merck Travel, Accommodations, Expenses: Merck Other Relationship: Basic Health International Karla Alfaro No relationship to disclose Mauricio Maza No relationship to disclose Philip E. Castle No relationship to disclose Albert Zevallos No relationship to disclose Ana Cecilia Diaz de Uriarte No relationship to disclose Manuel Alvarez No relationship to disclose Manuel Salinas No relationship to disclose Ana Sofia Ore No relationship to disclose Luis Taxa No relationship to disclose Juan Felix Expert Testimony: Johnson & Johnson, Philip Morris