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Fluorescence colposcope with dye TMTP1-PEG4-ICG is comparable to the conventional colposcope with acetic acid and Lugol's iodine in identifying cervical precancerous lesions - A randomized controlled trial
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  • Juncheng Wei,
  • Ying Zhou,
  • Chen Wang,
  • Wei Li,
  • Wanrong Lu,
  • Xiaohu Liu,
  • Ling Xi,
  • Pengcheng Li,
  • Jinling Lu
Juncheng Wei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Ying Zhou
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
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Wanrong Lu
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Xiaohu Liu
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Ling Xi
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Pengcheng Li
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Jinling Lu
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Abstract

Objective: To compare the diagnostic efficiency of fluorescence colposcope with dye TMTP1-PEG4-ICG versus conventional colposcope with acetic acid and Lugol’s iodine in identifying cervical precancerous lesions. Design and setting: Randomized controlled trial conducted at Colposcopy Center. Population: Women with abnormal cervical cancer screening results including cytology and/or HPV test. Methods: All participants were randomized to fluorescence colposcope group or conventional colposcope group. Patients of fluorescence colposcope group were applied dye TMTP1-PEG4-ICG to the cervix uteri. Patients of conventional colposcope group routinely administrated acetic acid and Lugol’s iodine to stain the cervix uteri. Main outcome measures: The colposcopists gave colposcope assessment impressions according to the cervical staining reactions and fluorescence signal-to-background ratio (SBR) calculation results. The diagnostic efficiency of fluorescence colposcope and conventional colposcope was calculated on a per-patient and per-site basis. Results: 195 women were successfully completed the study protocol and were randomized to fluorescence colposcope group (n=97) and conventional colposcope group (n=98). The accuracy, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of fluorescence colposcope on a per-patient basis were 61.9%, 66.7%, 61.0%, 23.8%, 90.9%, respectively. The above data corresponded to 73.9%, 69.6%, 74.2%, 15.5%, and 97.3% on a per-site basis in fluorescence colposcope group. In the conventional colposcope group, the above diagnostic indicators corresponded to 59.2%, 54.2%, 60.8%, 31.0%, 80.4%, respectively. Conclusions: The fluorescence colposcope with dye TMTP1-PEG4-ICG was comparable to the conventional colposcope with acetic acid and Lugol’s iodine, and exhibited better accuracy, sensitivity and excellent NPV on the basis of per cervical sites.

Peer review status:UNDER REVIEW

13 May 2021Submitted to BJOG: An International Journal of Obstetrics and Gynaecology
13 May 2021Assigned to Editor
13 May 2021Submission Checks Completed
18 May 2021Reviewer(s) Assigned