Impact of Computer-aided Optical Diagnosis (CAD) in Predicting Histology of Diminutive Rectosigmoid Polyps: a Multicenter Prospective Trial (ABC Study).

Completed

• Conditions: Colonic Adenomatous Polyp

• Registration Number: NCT04607083
• Lead Sponsor: Valduce Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-22
• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-10-22
• Study First Posted: 2020-10-28
• Primary Completion: 2021-02-27
• Study Completion: 2021-03-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1134

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Agreement of combined prediction with PIVI I statement	6 months	To 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 (i.e. PIVI I threshold) having histopathology as reference standard.

Secondary Outcome Measures

Name	Time	Method
Endoscopist prediction	6 months	to calculate the performance measures (sensitivity, specificity, positive and negative predictive value) of the endoscopist alone in characterizing diminutive rectosigmoid polyps
Agreement of combined prediction with PIVI II statement	6 months	- to evaluate if the evaluation of the endoscopist combined with the CAD system output achieve \> 90% accuracy in the assignment of post-polypectomy surveillance intervals, according to US and EU guidelines, when combined with the histopathology assessment of polyps \>5 mm in size
Ai prediction	6 months	- to calculate the performance measures (sensitivity, specificity, positive and negative predictive value) of the AI system alone in characterizing diminutive rectosigmoid polyps

Trial Locations

Locations (1)

Gastroenterology Unit, Valduce Hospital; 🇮🇹 Como, Italy