Development and Validation of an Artificial Intelligence System for Bowel Preparation Quality Scoring

Colonic Disease Clinical Trial

Official title:

Development and Validation of an Artificial Intelligence System for Bowel Preparation Quality Scoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04487626
• Other study ID #: NCC2020-0159
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2021
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to develop and validate the accuracy and reliability of an artificial intelligence(AI) system for bowel preparation quality scoring based of Boston Bowel preparation Scoring(BBPS). Then evaluate whether this AI system can help endoscopists to improve the quality of colonoscopy in clinical practice.

Description:

Bowel preparation is one of the most important factors which decide the quality of colonoscopy. Adequate bowel preparation is essential to guarantee a clear vision of colonic mucosa, complete inspection of entire colon and improves the adenoma detection rates(ADRs). Therefore, the quality of bowel preparation should be evaluated accurately and objectively. However, current bowel preparation quality scales depend on memories and subjective decision of endoscopists. Recently, articifial intelligence system based on deep learning algorithm has been used widely in medical fields. But, few studies have been reported to evaluate the performance of AI system based on deep learning in bowel preparation quality scoring. This study aims to develop and train an AI system to assess bowel preparation quality using the BBPS, and validate the AI system to improve the quality of colonoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 30, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients aged 20-80 years undergoing elective colonoscopy

Exclusion Criteria:

• Patients received colon or rectal surgery

Related Conditions & MeSH terms

• Colonic Disease
• Colonic Diseases

Intervention

Device:
• AI
After taking standard bowel preparation regimen, patients receive colonoscopy under the AI system device. During the withdrawal phase, bowel preparation quality is assessed by AI-associated scoring system. The withdrawal time is targeted at least 6min. Every detected polyp will be removed and obtained for pathological assessment.

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accuracy of bowel preparation score	Bowel preparation quality was measured by BBPS. After fully washing or suctioning of colonic contents, three segments including right colon (containing cecum and ascending colon), transvers colon (containing hepatic and splenic flexures) and left colon (containing descending and sigmoid colon) were individually scored from 0 to 3. Point 0 refers to unprepared colon segment with obscured solid stool making mucosa cannot be seen; Point 1 refers to part of mucosa can be seen, but some areas are covered by staining, residual stool, and/or opaque liquid; Point 2 refers to entire mucosa is well-seen; Point 3 refers to clean colon segment without staining, fecal materials or liquids. A sub-score of each colon segment was used, ranging from minimum 0 to maximum 3. The highest score means the excellent bowel preparation. Adequate bowel preparation was defined as a total BBPS=6 and sub-BBPS=2 per segment.	6 months