Automatic Evaluation of Inflammation Activity in Ulcerative Colitis Using pCLE With Artificial Intelligence

• Conditions: Confocal Laser Endomicroscopy; Ulcerative Colitis; Artificial Intelligence
• Interventions: Diagnostic Test: The diagnosis of Artificial Intelligence and endoscopist

• Registration Number: NCT04131530
• Lead Sponsor: Shandong University

Brief Summary

Probe-based confocal laser endomicroscopy (pCLE) is an endoscopic technique that enables to evaluate the inflammation activity of ulcerative colitis with excellent correlation with histopathology. However this requires much experience, which limits the application of pCLE. The investigators designed a computer-aided diagnosis program using deep neural network to make diagnosis automatically in pCLE examination and contrast its performance with endoscopists.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study Start: 2019-10
• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-10-17
• Last Update Submitted: 2019-10-17
• Study First Posted: 2019-10-18
• Last Update Posted: 2019-10-18
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• aged between 18 and 80; diagnosed as UC

Exclusion Criteria

• Patients under conditions unsuitable for performing CLE including coagulopathy , impaired renal or hepatic function, pregnancy or breastfeeding, and known allergy to fluorescein sodium; Inability to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Colon mucosa observed by pCLE	The diagnosis of Artificial Intelligence and endoscopist	pCLE is used to evaluate the inflammation activity in different parts of the colon mucosa

Primary Outcome Measures

Name	Time	Method
The diagnosis efficiency of Artificial Intelligence	3 months	The primary outcome is to test the diagnostic accuracy, sensitivity, specificity, PPV, NPV of the Artificial Intelligence for evaluation of inflammation activity of UC on pCLE examination.

Secondary Outcome Measures

Name	Time	Method
Contrast the diagnosis efficiency of Artificial Intelligence with endoscopists	3 months	The secondary outcome is to compare the diagnosis efficiency (including diagnostic accuracy, sensitivity, specificity, PPV, NPV ) between Artificial Intelligence and endoscopists.

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China