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

Colonic Adenomatous Polyp Clinical Trial

— ABC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04607083
• Other study ID #: 599/2020
• Status: Completed
• Start date: October 22, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: June 2021
• Source: Valduce Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1134
• Est. completion date: March 30, 2021
• Est. primary completion date: February 27, 2021
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomatous Polyps
• Colonic Adenomatous Polyp
• Polyps

Intervention

Diagnostic Test:
• Polyp carachterization by combing endoscopist evaluation and Ai output
A polyp characterization (adenoma vs. non adenoma) is provided by endoscopist in light of the results of this own evaluation and of the Ai system output. The confidence level (high vs. low) in polyp characterization is recorded. The combined evaluation is compared with histopathology results.

Locations

Country	Name	City	State
Italy	Gastroenterology Unit, Valduce Hospital	Como

Sponsors (1)

Lead Sponsor	Collaborator
Valduce Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement of combined prediction with PIVI I statement	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.	6 months
Secondary	Endoscopist prediction	to calculate the performance measures (sensitivity, specificity, positive and negative predictive value) of the endoscopist alone in characterizing diminutive rectosigmoid polyps	6 months
Secondary	Ai prediction	- to calculate the performance measures (sensitivity, specificity, positive and negative predictive value) of the AI system alone in characterizing diminutive rectosigmoid polyps	6 months
Secondary	Agreement of combined prediction with PIVI II statement	- 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	6 months