Abstract
In low-income countries, up to 80% of women diagnosed with cervical dysplasia do not return for follow-up care, primarily due to treatment being inaccessible. Here, we describe development of a low-cost, portable treatment suitable for such settings. It is based on injection of ethyl cellulose (EC)-ethanol to ablate the transformation zone around the os, the site most impacted by dysplasia. EC is a polymer that sequesters the ethanol within a prescribed volume when injected into tissue, and this is modulated by the injected volume and delivery parameters (needle gauge, bevel orientation, insertion rate, depth, and infusion rate). Salient injection-based delivery parameters were varied in excised swine cervices. The resulting injection distribution volume was imaged with a wide-field fluorescence imaging device or computed tomography. A 27G needle and insertion rate of 10 mm/s achieved the desired insertion depth in tissue. Orienting the needle bevel towards the outer edge of the cervix and keeping infusion volumes ≤ 500 µL minimized leakage into off-target tissue. These results guided development of a custom hand-held injector, which was used to locate and ablate the upper quadrant of a swine cervix in vivo with no adverse events or changes in host temperature or heart rate. After 24 h, a distinct region of necrosis was detected that covered a majority (> 75%) of the upper quadrant of the cervix, indicating four injections could effectively cover the full cervix. The work here informs follow up large animal in vivo studies, e.g. in swine, to further assess safety and efficacy of EC-ethanol ablation in the cervix.
Highlights
IntroductionIn low-income countries, up to 80% of women diagnosed with cervical dysplasia do not return for follow-up care, primarily due to treatment being inaccessible
Patients with an elevated risk of CIN3 are treated with an excisional outpatient procedure called Loop Electrosurgical Excision Procedure (LEEP) or cold knife cone during which the lesion and the cervical transformation zone are excised for further pathologic evaluation[1]
The World Health Organization (WHO) recommends the use of ablative therapies, including cryotherapy and thermocoagulation, to treat cervical pre-cancer in low- and middle-income countries (LMICs) because they cost less than excisional procedures, do not require removing tissue, leaving the cervix intact, and can be performed by non-specialists in primary care settings[14]
Summary
In low-income countries, up to 80% of women diagnosed with cervical dysplasia do not return for follow-up care, primarily due to treatment being inaccessible. In light of the above, the World Health Organization (WHO) recommends adoption of alternative protocols in LMICs that employ accessible technologies to screen and treat cervical pre-cancer in a single visit with a primary care p rovider[14] In this regard, significant technological advances have been made in developing more accessible HPV testing[15] and low-cost colposcopy[16]. The WHO recommends the use of ablative therapies, including cryotherapy and thermocoagulation, to treat cervical pre-cancer in LMICs because they cost less than excisional procedures, do not require removing tissue, leaving the cervix intact, and can be performed by non-specialists in primary care settings[14]. There is an unmet need for an accessible, robust therapeutic for LMICs that could be expanded to treat disease in the endocervical canal and for treatment of early carcinomas
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