A Prospective Randomized Trial to Compare Safety, Acceptability and Efficacy of Thermal Ablation and Cryotherapy in a Screen and Treat Setting.

Dipanwita Banerjee,Ishita Ghosh,Amit Mandal,Partha Basu,Srabani Mittal,Eric Lucas,Richard Muwonge,Ranajit Mandal

doi:10.31557/apjcp.2020.21.5.1391

Abstract

Background:The prospective randomized study aimed to compare the safety, acceptability and efficacy of thermal ablation (TA) to that of cryotherapy in screen and treat setting. Methods:The participants were recruited prospectively in a community-based screening clinic in India. Women positive on visual inspection with acetic acid (VIA) test and/or Human Papillomavirus (HPV) test were assessed for eligibility for ablative treatment. Total 286 eligible women were randomized to receive either cryotherapy (N=150) or TA (N=136) performed by health workers. Colposcopy and cervical biopsy were performed on all, prior to treatment. Post-treatment follow-up was after one year with colposcopy and biopsy. Results:Both the treatment methods had high acceptability. Significantly higher proportion of women treated by cryotherapy reported pain compared to women treated by TA, though intensity was mild in vast majority of them. Approximately 30% of women in both arms had histologic abnormalities, mainly CIN 1, and among those who attended follow-up 74.1% and 81.0% didn’t have any CIN after cryotherapy and TA respectively. Conclusion:TA is as acceptable and safe as cryotherapy in screen and treat setting. TA has the logistic advantages for the low-resourced settings as the machines are more portable, do not require costly refrigerant gas and battery-driven models are available. The cure rates for CIN 1+ lesions in our study were comparable between cryotherapy and TA.

Highlights

Screening for cervical cancer followed by treatment of the screen detected abnormalities in the primary care settings has been endorsed by the World Health Organization (WHO) as one of the ‘best buys’ for cancer prevention (WHO, 2017)
The prospective randomized study was conducted at Chittaranjan National Cancer Institute (CNCI), India and the participants were recruited between February 2016 and July 2017
The outcomes of the screening tests, colposcopy and histopathology at baseline are shown in table 2

Summary

Introduction

Screening for cervical cancer followed by treatment of the screen detected abnormalities in the primary care settings has been endorsed by the World Health Organization (WHO) as one of the ‘best buys’ for cancer prevention (WHO, 2017). Ablative treatment of the screen-positive women without disease verification by complex diagnostic tests like colposcopy and histopathology, is effective and safe and well-accepted in low-resourced settings (Gaffikin et al, 2003; Denny et al, 2005; Denny et al, 2010). It was recognized that there was ‘very low certainty in the evidence of effects’ due to the paucity of randomized studies evaluating the safety and efficacy of thermal ablation. The prospective randomized study aimed to compare the safety, acceptability and efficacy of thermal ablation (TA) to that of cryotherapy in screen and treat setting. Women positive on visual inspection with acetic acid (VIA) test and/ or Human Papillomavirus (HPV) test were assessed for eligibility for ablative treatment. The cure rates for CIN 1+ lesions in our study were comparable between cryotherapy and TA

Methods

Results

Conclusion