Multi-center Validation of a Deep Learning Based Bowel Preparation Evaluation System

Validation of a Deep Learning Based Bowel Preparation Evaluation System: A Prospective, Multi-center, Cross-sectional Study

A deep learning based system to calculate the proportion of Boston Bowel Prep Scale (BBPS) score of 0-1 during withdrawal phase has been constructed previously. This multi-center study is going to perform a prospective observational study to validate the threshold of the adequate proportion.

Study Overview

• Status: Unknown
• Conditions: Adenoma; Bowel Preparation
• Intervention / Treatment: Other: Observational group

Detailed Description

Inadequate bowel preparation is insufficient for identification of polyps greater than 5 mm. However, bowel preparation assessment involved subjectivity and uncertainty. We constructed a deep learning based system to calculate the proportion of Boston Bowel Prep Scale (BBPS) score of 0-1 during withdrawal phase and performed a prospective observational study to validate the threshold of the adequate proportion.The multi-center study is aimed to verify the extrapolation and robustness of the scoring threshold based on artificial intelligence intestinal cleanliness evaluation system explored in the early stage, and propose a more accurate and quantifiable threshold for evaluating the eligibility of intestinal preparation.

• Study Type: Observational
• Enrollment (Anticipated): 1400

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Recruiting
      • Renmin Hospital of Wuhan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Continuous colonoscopy from October to December 2020 will be collected in our participating general hospitals.

Description

Inclusion Criteria:

• Male or female aged 18 years or above;
• Ability to read, understand and sign informed consent forms;
• The researchers believe that the subjects can understand the process of the clinical study and are willing and able to complete all the study procedures and follow-up visits to cooperate with the study procedures.

Exclusion Criteria:

• Patients with contraindications to colonoscopy (obstruction or perforation, severe acute inflammatory bowel disease, toxic megacolon, severe heart failure, severe heart failure, etc.);
• Patients with galactosemia;
• Pregnant or lactating women;
• Patients used lactulose, a stimulant, or laxative within 7 days;
• Patients refused to sign informed consent forms.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational group; Patients received bowel preparation and colonoscopy. The withdrawal phase video was saved and their lesions detection was record.	Other: Observational group; Patient receive the standard bowel preparation strategy and routine colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate	The numerator is the number of cases of adenomas detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy.	3 Months
Cleanliness assessment of different intestinal segment in the artificial intelligence system	The Artificial intelligence evaluates the Boston Bowel Preparation score of the ascending colon, transverse colon and descending colon in real-time, and calculates the proportion of 0-1 Score	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Advanced adenoma detection rate	The numerator is the number of cases of advanced adenomas detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy.	3 Months
Polyps detection rate	The numerator is the number of cases of polyps detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy.	3 Months
The mean number of adenomas per procedure	The numerator is the total number of polyps detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy	3 Months
Detection rate of large, small and diminutive polyps	The numerator was the number of patients with large (≥10 mm), small (>5 to <10 mm), and diminutive(≤5 mm) polyps detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.	3 Months
The mean number of large, small and diminutive polyps per procedure	The numerator was the number of large (≥10 mm), small (>5 to <10 mm), and diminutive(≤5 mm) polyps detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.	3 Months
Detection rate of large, small and diminutive adenomas	The numerator was the number of patients with large (≥10 mm), small (>5 to <10 mm), and diminutive(≤5 mm) adenomas detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.	3 Months
The mean number of large, small and diminutive adenomas per procedure	The numerator was the number of large (≥10 mm), small (>5 to <10 mm), and diminutive(≤5 mm) adenomas detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.	3 Months
Detection rate of adenoma in different sites	The numerator is the number of cases of adenoma detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon and ileocecal region during colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.	3 Months
The mean number of adenomas in different sites per procedure	The numerator is the total number of adenomas detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon and ileocecal region during colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.	3 Months
Time of colonoscopic insertion/withdrawal	The duration of colonoscopic insertion from rectum to ileocecal valve or appendiceal opening and the duration of colonoscopic withdrawal from ileocecal valve or appendiceal opening to colonoscopy finished.	3 Months

Collaborators and Investigators

• Sponsor: Renmin Hospital of Wuhan University
• Collaborators: Hubei Hospital of Traditional Chinese Medicine; Wuhan Central Hospital; The Third People's Hospital of Hubei Province; Wuhan Third Hospital; Wuhan Puren Hospital; The General Hospital of Central Theater Command; Wuhan Puai Hospital; Tian You Hospital Affiliated to Wuhan University of Science and Technology; Wuhan Red Cross Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 9, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: EA-20-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No