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Clinical Trials/NCT03908645
NCT03908645
Unknown
Not Applicable

Development and Validation of a Deep Learning Algorithm for Bowel Preparation Quality Scoring

Shandong University1 site in 1 country100 target enrollmentDecember 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bowel Preparation
Sponsor
Shandong University
Enrollment
100
Locations
1
Primary Endpoint
The rate of patients achieving adequate bowel preparation in each group.
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this study is to develop and validate the performance of an artificial intelligence(AI) assisted Boston Bowel preparation Scoring(BBPS) system for evaluation of bowel cleanness, then testify whether this new scoring system can help physicians to improve the quality control parameters of colonoscopy in clinic practice.

Detailed Description

Colonoscopy is recommended as a routine examination for colorectal cancer screening. Adequate bowel preparation is indispensable to ensure a clear vision of colonic mucosa,complete inspection of all colon segments, and furthermore improves the detection rates of small adenomas. Thus, the adequacy of bowel preparation should be accurately evaluated and documented. However, the accuracy of current bowel preparation quality scales greatly relies on intra-observer and inter-observer consistency for lack of objective measurements. Recently, deep learning based on central neural networks (CNN) has shown multiple potential in computer-aided detection and computer-aided diagnose of gastrointestinal lesions. While, no studies have been conducted to evaluate the performance of deep learning algorithm in bowel preparation quality scoring. This study aims to train an algorithm to assess bowel preparation quality using the BBPS, and testify whether the engagement of AI can improve the quality control parameters of colonoscopy.

Registry
clinicaltrials.gov
Start Date
December 15, 2018
End Date
April 15, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shandong University
Responsible Party
Principal Investigator
Principal Investigator

Xiuli Zuo

director of Qilu Hospital gastroenterology department

Shandong University

Eligibility Criteria

Inclusion Criteria

  • Patients aged 18-70 years undergoing afternoon colonoscopy

Exclusion Criteria

  • Known or suspected bowel obstruction, stricture or perforation
  • Compromised swallowing reflex or mental status
  • Severe chronic renal failure(creatinine clearance \< 30 ml/min)
  • Severe congestive heart failure (New York Heart Association class III or IV)
  • Uncontrolled hypertension (systolic blood pressure \> 170 mm Hg, diastolic blood pressure \> 100 mm Hg)
  • Dehydration
  • Disturbance of electrolytes
  • Pregnancy or lactation
  • Hemodynamically unstable
  • Unable to give informed consent

Outcomes

Primary Outcomes

The rate of patients achieving adequate bowel preparation in each group.

Time Frame: 6 months

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.

Secondary Outcomes

  • Adenoma Detection Rate(6 months)
  • Polyp Detection Rate(6 months)

Study Sites (1)

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