Development and Validation of a Deep Learning Algorithm to Evaluate Endoscopic Disease Activity of Ulcerative Colitis.

NCT03973437 | Unknown DMC

• 1 other identifier: 2019-SDU-QILU-G002
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop an artificial intelligence(AI) assisted scoring system, which can evaluate the disease severity and mucosal healing stage in patients with ulcerative colitis. Then testify whether this new scoring system can help physicians to enhance the accuracy of disease severity assessments in a multi-center clinical practice.

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis; Deep Learning; Convolutional Neural Network

Outcome Measures

Primary Outcomes (2)

• The scoring accuracy of Mayo ES in AI-associated group and conventional group.

  The scoring accuracy of Mayo endoscopic sub-score (Mayo ES) in each group will be calculated using scores from expert group as reference standard. The Mayo ES is a 4-point scale, which classifies the endoscopic severity of ulcerative colitis into the following four categories: point 0 refers to normal or inactive disease, point 1 refers to mild disease with erythema, decreased vascular patterns and mild friability, point 2 refers to moderate disease with marked erythema, absence of vascular patterns, friability and erosions, point 3 refers to severe disease with spontaneous bleed and ulceration. The scoring accuracy of Mayo ES ranging from 0 to 3 point will be separately evaluated in both groups.

  6 months

• The scoring accuracy of UCEIS in AI-associated group and conventional group.

  The scoring accuracy of Ulcerative colitis endoscopic index of severity (UCEIS) in each group will be separately calculated using scores from expert group as reference standard. The UCEIS is an 8-point scale consists of 3 parts: vascular pattern (point 0 refers to normal mucosa, point 1 refers to patchy obliteration of vascular pattern, point 2 refers to complete obliteration of vascular pattern), bleeding (point 0 refers to no visible blood, point 1 refers to some spots of coagulated blood, point 2 refers to free liquid, point 3 refers to frank blood in the lumen), erosions and ulcers (point 0 refers to normal mucosa, point 1 refers to erosions, point 2 refers to superficial ulcers, point 3 refers to deep ulcers. The total UCEIS score summarized by the above 3 parts will be analyzed. The scoring accuracy of UCEIS ranging from 0 to 8 point will be separately evaluated in both group.

  6 months

Secondary Outcomes (2)

• The accuracy of mucosal healing judgements using Mayo ES in each group.

  6 months

• The accuracy of mucosal healing judgements using UCEIS in each group.

  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 inteligence associated ulcerative colitis severity 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 inteligence associated ulcerative colitis severity scoring system DEVICE

Patients in this group go through a flexible colonoscopy under the AI monitoring device. During the withdrawal process, inflammatory lesions are detected by AI-associated scoring system. Pictures are automatically captured and analyzed by the computer. The Mayo ES and UCEIS sores will be calculated and presented on a second screen, providing a reference for the physician to evaluate the disease severity and mucosal healing stage of the patient. Biopsies will be taken from inflammatory region for histological examination. Videos will be recorded and re-evaluated by a group of experts to determine the final Mayo ES and UCEIS scores.

Artificial Intelligence assisted Scoring Group

Conventional human scoring DEVICE

Patients in this group go through a conventional colonoscopy without the AI monitoring device. During the withdrawal process, physician evaluates the disease severity and mucosal healing stage of the patient according to his personal experience. Biopsies will be taken from inflammatory region for histological examination. Videos will be recorded and re-evaluated by a group of experts to determine the final Mayo ES and UCEIS scores.

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 with ulcerative colitis undergoing colonoscopy

You may not qualify if:

• Known or suspected bowel obstruction, stricture or perforation
• Compromised swallowing reflex or mental status
• 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)
• Pregnancy or lactation
• Hemodynamically unstable
• Colonic surgery history
• Bad bowel preparation (segmental BBPS\<2)
• Unable to give informed consent

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu hosipital

Jinan, Shandong, 257000, China

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Xiuli Zuo, MD,PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuli Zuo, MD,PhD

CONTACT

15588818685; zuoxiuli@sina.com

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: May 27, 2019
• First Posted: June 4, 2019
• Study Start: June 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: June 1, 2020
• Last Updated: June 4, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)