BJOG : an international journal of obstetrics and gynaecology · 2010
Dynamic spectral imaging colposcopy: higher sensitivity for detection of premalignant cervical lesions.
Сравнительное исследованиеОценочное исследованиеСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Louwers Ja, Zaal A, Kocken M, Ter Harmsel Wa, Graziosi Gcm, Spruijt Jwm, Berkhof J, Balas C, Papagiannakis E, Snijders Pjf, Meijer Cjlm, van Kemenade Fj, Verheijen Rhm
Аннотация
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.
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.