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OpenTrials
Completed

NCT Number: NCT04136236

Automatic Diagnosis of Early Esophageal Squamous Neoplasia Using pCLE With AI

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.

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Key information

Conditions

Esophageal Neoplasms Artificial Intelligence Confocal Laser Endomicroscopy Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qilu Hospital, Shandong University

Jinan, Shandong, 250001, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged between 18 and 80;
  • agree to give written informed consent；

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. The diagnosis efficiency of Artificial Intelligence

    Time frame: 3 years

    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.

Secondary outcomes

  1. Contrast the diagnosis efficiency of Artificial Intelligence with endoscopists

    Time frame: 1 month

    The secondary outcome is to compare the diagnosis efficiency (including diagnostic accuracy, sensitivity, specificity, PPV, NPV for diagnosing esophageal mucosal disease on real-time pCLE examination) between Artificial Intelligence and endoscopists.

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

Automatic Diagnosis of Early Esophageal Squamous Neoplasia Using Probe-based Confocal Laser Endomicroscopy With Artificial Intelligence

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 23, 2019
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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