Dynamic spectral imaging colposcopy: higher sensitivity for detection of premalignant cervical lesions

Authors


Dr RHM Verheijen, University Medical Centre Utrecht, Division of Women and Baby, Gynaecological Oncology, PO Box 85500, 3508 GA, Utrecht, the Netherlands. Email r.verheijen@umcutrecht.nl

Abstract

Please cite this paper as: Louwers J, Zaal A, Kocken M, ter Harmsel W, Graziosi G, Spruijt J, Berkhof J, Balas C, Papagiannakis E, Snijders P, Meijer C, van Kemenade F, Verheijen R. Dynamic spectral imaging colposcopy: higher sensitivity for detection of premalignant cervical lesions. BJOG 2011;118:309–318.

Objective  To validate the dynamic spectral imaging (DSI) colposcope’s colour-coded map in discriminating high- from low-grade cervical lesions and non-neoplastic tissue.

Design  Prospective, comparative, multicentre clinical trial.

Setting  The colposcopy clinics of three Dutch hospitals.

Population  Women of 18 years or over with an intact cervix, referred for colposcopy.

Methods  During a 3-minute image acquisition phase, the DSI colposcope was used as a regular video colposcope: the colposcopist located and graded potential lesions based on conventional colposcopic criteria. Subsequently, a colour-coded map was calculated and displayed, representing localisation and severity of the cervical lesion. Biopsies were collected from all atypical sites, as identified by digital mapping and/or conventional colposcopy. Furthermore, one additional biopsy was taken.

Main outcome measures  Histologically confirmed high-grade cervical disease (CIN2+).

Results  In total 275 women were included in the study: 183 women were analysed in the ‘according-to-protocol’ (ATP) cohort and 239 women in the ‘intention-to-treat’ (ITT) cohort. In the ATP cohort, the sensitivity of DSI colposcopy to identify women with high-grade (CIN2+) lesions was 79% (95% CI 70–88) and the sensitivity of conventional colposcopy was 55% (95% CI 44–65) (P = 0.0006, asymptotic McNemar test). When the DSI colour-coded map was combined with conventional colposcopy, the sensitivity was 88% (95% CI 82–95).

Conclusions  DSI colposcopy has a significantly higher sensitivity to detect cervical lesions than conventional colposcopy. If the colour-coded map is combined with conventional colposcopic examination, the sensitivity increases further.

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