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

Adenoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04591145
• Other study ID #: EA-20-002
• Status: Recruiting
• Start date: October 9, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2020
• Source: Renmin Hospital of Wuhan University
• Contact: Honggang Yu, MD
• Phone: +8613871281899
• Email: yuhonggang1968[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Bowel Preparation

Intervention

Other:
• Observational group
Patient receive the standard bowel preparation strategy and routine colonoscopy

Locations

Country	Name	City	State
China	Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (10)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University	General Hospital of the Central Theater Command of the People's Liberation Army, Hubei Hospital of Traditional Chinese Medicine, The Central Hospital of Wuhan, The Third People's Hospital of Hubei, Tian You Hospital Affiliated to Wuhan University of Science and Technology, Wuhan Puai Hospital, Wuhan Puren Hospital, Wuhan Red Cross Hospital, Wuhan Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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