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

NCT04131530 | Unknown

• 1 other identifier: 2019SDU-QILU-10
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis; Artificial Intelligence; Confocal Laser Endomicroscopy

Outcome Measures

Primary Outcomes (1)

• The diagnosis efficiency of Artificial Intelligence

  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.

  3 months

Secondary Outcomes (1)

• Contrast the diagnosis efficiency of Artificial Intelligence with endoscopists

  3 months

Study Arms (1)

Colon mucosa observed by pCLE

pCLE is used to evaluate the inflammation activity in different parts of the colon mucosa

Diagnostic Test: The diagnosis of Artificial Intelligence and endoscopist

Interventions

The diagnosis of Artificial Intelligence and endoscopist DIAGNOSTIC_TEST

When the colon mucosa is observed using pCLE, endoscopist and AI will make a diagnosis independently. In addition, the endoscopist can not see the diagnosis of AI.

Colon mucosa observed by pCLE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients who receive the endoscopy pCLE examination and screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study

You may qualify if:

• aged between 18 and 80; diagnosed as UC

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Endoscopist will observe the colon mucosa of UC using pCLE and take biopsy for histology examination.

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

Study Officials

• Yanqing Li

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanqing Li

CONTACT

053182169385; liyanqing@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of QiLu Hospital

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 18, 2019
• Study Start: October 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 18, 2019

Record last verified: 2019-10

Locations

CN (1)