Impact of Computer-aided Optical Diagnosis (CAD) in Predicting Histology of Diminutive Rectosigmoid Polyps: a Multicenter Prospective Trial (Artificial Intelligence BLI Characterization - ABC Study).
Trial ID: NCT04607083
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2020-10-22
Completion date: 2021-03-30
Sponsor: Valduce Hospital
Conditions: Colonic Adenomatous Polyp
Interventions: Polyp carachterization by combing endoscopist evaluation and Ai output
Locations: Gastroenterology Unit, Valduce Hospital
Countries: Italy
Enrollment: 1134
Age range: 18 Years - 85 Years
Sex: ALL

Summary:
Recently, a CNN-based artificial intelligence (AI) system for polyp characterization has been developed by Fujifilm Co., Tokyo, Japan. It works in conjunction with BLI system. In the present study we prospectively evaluate whether the evaluation of the endoscopist combined with the CAD system output achieve \> 90% accuracy in characterization (i.e. as adenomas or non-adenomas) of diminutive rectosigmoid polyps having histopathology as reference standard. Consecutive adult outpatients undergoing elective colonoscopy, in which at least one diminutive (\<5 mm) rectosigmoid polyp is detected are included. During endoscopic procedures all polyps identified by the endoscopist are documented for size, location and morphology. All diminutive polyps are characterized by a three sequential steps process: I) endoscopist prediction: the endoscopist evaluates the polyp by using BLI through the BASIC classification; the confidence level (high vs. low) in histology prediction is recorded; II) AI prediction: the AI system is switched on and the output of the automatic evaluation is recorded; this outcome is rated as stable or unstable, depending of the consistency over time of the outcome; III) combined prediction: a final classification is provided by endoscopist in light of the results of the first and of the second step; the confidence level is recorded. All polyps are resected and retrieved in separate jars and sent for pathology assessment. Only polyps characterized with high confidence will be included in the per-polyp analysis; the high-confidence characterization rate will be also calculated; the rate of polyps characterized with a CAD stable outcome will be calculated. Operative characteristics (sensitivity, specificity, positive and negative predictive value and accuracy) in distinguishing adenomatous from non-adenomatous polyps, evaluated with high confidence, will be calculated for each diminutive polyp and for each diminutive rectosigmoid polyp, having histopathology report as reference standard. The post-polypectomy surveillance intervals will be calculated on the basis of polyp histology (reference standard) in all patients according to both USMSTF and ESGE guidelines.

Eligibility criteria:
Inclusion Criteria:

* Consecutive adult outpatients undergoing elective colonoscopy, in which at least one diminutive (\<5 mm) rectosigmoid polyp is detected.

Exclusion Criteria:

* patients with CRC history or hereditary polyposis syndromes or hereditary non-polyposis colorectal cancer
* patients with inadequate bowel preparation
* patients scheduled for partial examinations
* polyps could not be resected due to ongoing anticoagulation preventing resection and pathologic assessment
* patients undergoing urgent colonoscopy

Outcomes:
Agreement of combined prediction with PIVI I statement