Search

Implementing standard-of-care cryotherapy or electrosurgical excision to treat cervical precancers is challenging in resource-limited settings. An affordable technological alternative that is as effective as standard-of-care techniques would greatly improve access to treatment. This randomized controlled trial aims to demonstrate the noninferiority efficacy of a portable, battery-driven thermal ablation (TA) device compared to cryotherapy and electrosurgical excision (large loop excision of transformation zone (LLETZ)) to treat cervical precancer in a screen-and-treat program in Zambia. A total of 3,124 women positive on visual inspection with acetic acid and eligible for ablative therapy were randomized to one of the treatment arms. Human papillomavirus (HPV) testing was performed at baseline and at the follow-up. The primary outcome was treatment success, defined as either type-specific HPV clearance at the follow-up in participants positive for HPV at baseline, or a negative visual inspection with acetic acid test for those who had a negative HPV test at baseline. After a median follow-up of 12 months, treatment success rates were 74.0%, 71.1% and 71.4% for the TA, cryotherapy and LLETZ arms, respectively, thus demonstrating noninferiority (P= 0.83). TA was a safe and well-accepted procedure. Only 3.6% of those randomized to TA reported moderate-to-severe pain, compared to 6.5% and 1.9% for the cryotherapy and LLETZ arms, respectively. Thus, our randomized controlled trial demonstrates the safety and efficacy of TA, which is not inferior to cryotherapy or surgical excision.

(Abstracted from Lancet Oncol2020;21:175–184)The most commonly used approach for women with cervical precancer in low-income and middle-income countries (LMICs) is screening by visual inspection with acetic acid (VIA) followed by immediate cryotherapy of VIA-positive women (see-and-treat). There are a number of logistical problems with cryotherapy that have prompted development and evaluation of a cordless, lightweight, and battery-operated thermal ablator that has a much faster treatment duration (20–40 seconds) and does not require a gas supply.

(Abstracted from Lancet Oncol2020;21:175–184)Cervical cancer has a long and treatable precancerous phase, is easily screened for, and is common enough to justify population-based screening even in low- and middle-income countries (LMICs). The standard treatment in high-income countries is large loop excision of the transformation zone (LLETZ).