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

NCT03908645 | Unknown DMC

• 1 other identifier: 2019SDU-QILU-G001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Preparation

Keywords

Bowel Preparation, Deep Learning, Central Neural Networks

Outcome Measures

Primary Outcomes (1)

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

  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

Secondary Outcomes (2)

• Adenoma Detection Rate

  6 months

• Polyp Detection Rate

  6 months

Study Arms (2)

Artificial Intelligence assisted Scoring Group

EXPERIMENTAL

Patients in this group go through colonoscopy under the AI monitoring device.

Device: Artificial intelligence assisted bowel preparation quality scoring system

Conventional Human Scoring Group

ACTIVE COMPARATOR

Patients in this group go through conventional colonoscopy without AI monitoring device.

Device: Conventional human scoring

Interventions

Artificial intelligence assisted bowel preparation quality scoring system DEVICE

After receiving standard bowel preparation regimen, patients go through colonoscopy under the AI monitoring device. During the withdrawal process, bowel preparation quality is monitored by AI-associated scoring system. Whenever a sub-score below 2 points is detected, endoscopist will be alarmed up to three times to wash and suck the colonic contents. Videos will be recorded and re-evaluated by experts to determine the final BBPS score. The withdrawal time is targeted at least 6min in accordance with colonoscopy quality practice. All detected polyps will be removed and obtained for histological assessment, with the possible exception of diminutive(less than 5mm) rectal polyps.

Artificial Intelligence assisted Scoring Group

Conventional human scoring DEVICE

After receiving standard bowel preparation regimen, patients go through conventional colonoscopy without the AI monitoring device. During the withdrawal process, after washing and sucking the colonic contents according to endoscopist's personal experience, bowel preparation quality is evaluated by human. Videos will be recorded and re-evaluated by experts to determine the final BBPS score. The withdrawal time is targeted at least 6min in accordance with colonoscopy quality practice. All detected polyps will be removed and obtained for histological assessment, with the possible exception of diminutive(less than 5mm) rectal polyps.

Conventional Human Scoring Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-70 years undergoing afternoon colonoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu hosipital

Jinan, Shandong, 257000, China

Location

Study Officials

• Xiuli Zuo, MD,PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of Qilu Hospital gastroenterology department

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 9, 2019
• Study Start: December 15, 2018
• Primary Completion: December 15, 2019
• Study Completion: April 15, 2020
• Last Updated: April 9, 2019

Record last verified: 2019-04

Locations

CN (1)