Automatic Diagnosis of Early Esophageal Squamous Neoplasia Using pCLE With AI

NCT04136236 | Completed

• 1 other identifier: 2019SDU-QILU-66
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

Detection and differentiation of esophageal squamous neoplasia (ESN) are of value in improving patient outcomes. Probe-based confocal laser endomicroscopy (pCLE) can diagnose ESN accurately.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

Esophageal Neoplasms; 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 diagnosing esophageal mucosal disease on real-time pCLE examination.

  3 years

Secondary Outcomes (1)

• Contrast the diagnosis efficiency of Artificial Intelligence with endoscopists

  1 month

Study Arms (1)

esophageal mucosal lesions observed by pCLE

pCLE is used to distinguish the suspected lesions detected by white light endoscopy or IEE.

Diagnostic Test: The diagnosis of Artificial Intelligence and endoscopist

Interventions

The diagnosis of Artificial Intelligence and endoscopist DIAGNOSTIC_TEST

Suspected esophageal mucosal lesion is observed using pCLE, endoscopist and AI will make a diagnosis independently. In addition, the endoscopist can not see the diagnosis of AI. After a washout period, nonexpert endoscopists take the second assessment with AI assistance.

esophageal mucosal lesions 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 upper gastrointestinal tract 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;
• agree to give written informed consent；

You may not qualify if:

• advanced esophageal squamous cell carcinoma or esophageal stenosis;
• having no suspicious lesion of ESN found by WLE and IEE
• known allergy to fluorescein sodium;
• having coagulopathy or impaired renal function;
• being pregnant or breastfeeding.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, 250001, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

When suspected lesion is found using white light endoscopy , endoscopist will observe this lesion using pCLE and then take biopsy for histology examination.

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Yanqing Li

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 20, 2019
• First Posted: October 23, 2019
• Study Start: August 1, 2019
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

CN (1)