Optical diagnosis expanded to small polyps: post-hoc analysis of diagnostic performance in a prospective multicenter study

Endoscopy. 2019 Mar;51(3):244-252. doi: 10.1055/a-0759-1605. Epub 2018 Dec 13.

Abstract

Background: Optical diagnosis can replace histopathology of diminutive (1 - 5 mm) polyps if surveillance intervals based on optical diagnosis of polyps have ≥ 90 % agreement with intervals based on polyp histology and if the negative predictive value (NPV) for predicting neoplastic histology in the rectosigmoid is ≥ 90 %. This study aims to assess whether small (6 - 9 mm) polyps can be included in optical diagnosis strategies.

Method: This is a post-hoc analysis of a prospective multicenter study in which 27 endoscopists, all performing endoscopies for the Dutch screening program, were trained in optical diagnosis. For 1 year, endoscopists recorded the predicted histology for all lesions detected using narrow-band imaging during 3144 consecutive colonoscopies after a positive fecal immunochemical test, along with confidence levels. Surveillance interval agreement and NPV were calculated for high confidence predictions for polyps of 1 - 9 mm and compared with histopathology. Surveillance interval agreement was calculated using the European Society of Gastrointestinal Endoscopy surveillance guideline.

Results: Surveillance interval agreement was 95.4 % (confidence interval [CI] 94.2 % - 96.4 %), and NPV for predicting neoplastic histology in the rectosigmoid 90.0 % (CI 87.3 % - 92.2 %). The reduction in histology (45.9 % vs. 30.5 %) and the proportion of patients who could have received direct surveillance advice (15.6 % vs. 7.3 %) was higher when small polyps were included (P < 0.001). T1 cancer was found in seven small polyps (0.33 %), five of which would have been discarded without histopathology.

Conclusion: Including small polyps in the optical diagnosis strategy improves its efficacy while maintaining performance thresholds. However, there is a small risk of missing T1 cancers when small polyps are included in the optical diagnosis strategy.

Trial registration: ClinicalTrials.gov NCT02407925.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Colonic Polyps / diagnosis*
  • Colonic Polyps / pathology
  • Colonoscopy / education*
  • Colonoscopy / methods*
  • Colorectal Neoplasms / diagnosis*
  • Colorectal Neoplasms / pathology
  • Female
  • Humans
  • Male
  • Middle Aged
  • Narrow Band Imaging / methods*
  • Netherlands
  • Predictive Value of Tests
  • Prospective Studies
  • Sensitivity and Specificity

Associated data

  • ClinicalTrials.gov/NCT02407925