NCT03973437

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

Real-time Evaluation of Severity and Mucosal Healing in Patients With Ulcerative Colitis by a Deep Learning Algorithm: a Multi-center Prospective Study.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Ulcerative colitis is a non-specific chronic inflammation of gut characterized by referral bloody stool, diarrhea and abdominal pain. Endoscopic features of the disease severity and mucosal healing stage are strongly associated with treatment response and prognosis in the future. Currently, the Mayo endoscopic sub-score (Mayo ES) and Ulcerative colitis endoscopic index of severity (UCEIS) are commonly recommended to guide therapeutic adjustments. However, the accuracy of these scales greatly relies on intra-observer and inter-observer consistency for lack of objective measurements. Recently, deep learning algorithm based on convolutional neural network (CNN) has shown multiple potential in computer-aided detection and computer-aided diagnose of gastrointestinal lesions. Up to now, no randomized controlled trials have been conducted to evaluate the performance of deep learning algorithm for assessing disease activity in ulcerative colitis. This study aims to train a deep learnig algorithm to assess severity and mucosal healing stage of ulcerative colitis using the Mayo ES and UCEIS scale, then testify whether the engagement of AI can improve the evaluation accuracy of physicians in a multi-center clinical practice.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DEVICE	Artificial inteligence associated ulcerative colitis severity scoring system	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.
DEVICE	Conventional human scoring	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.

Timeline

• Start date: 2019-06-01
• Primary completion: 2019-12-31
• Completion: 2020-06-01
• First posted: 2019-06-04
• Last updated: 2019-06-04

Locations

1 site across 1 country: China