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CompletedNCT05858827Updated Jan 12, 2024

To Evaluate the Capability of an EUS Automatic Image Reporting System

An observational study in Endoscopic Ultrasonography and Artificial Intelligence, sponsored by Renmin Hospital of Wuhan University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-12.

Sponsored by Renmin Hospital of Wuhan University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
114
Ages
18 Years and older
Sex
All
01

Study summary

In this study, the EUS intelligent picture reporting system can automatically generate reports after reading videos of EUS examinations. This function can standardize the quality of endoscopic ultrasound image reporting and reduce the work burden of ultrasound endoscopists.

Read the detailed description

A well-written report is the most important way of communication between clinicians, referring doctors and patients. Reports play a key role for quality improvement in digestive endoscopy, too. Unlike digestive endoscopy, the quality of reporting in endoscopic ultrasound (EUS) has not been thoroughly evaluated and a reference standard is lacking. According to the guidance statements regarding standard EUS reporting elements developed and reviewed at the Forum for Canadian Endoscopic Ultrasound 2019 Annual Meeting, appropriate photo documentation of all relevant lesions and anatomical landmarks should be included in EUS reports and stored for future reference. Systematic photo documentation in EUS is an indicator of procedure quality according to the ASGE. Systematic photo documentation can facilitate surveillance EUS evaluations. According to an international online survey, most endosonographers used a structured tree in the report describing either normal and abnormal findings (81%) or only abnormal findings (7%). Therefore, it is necessary to develop a standardized endoscopic ultrasound image report system.

The past decades have witnessed the remarkable progress of artificial intelligence (AI) in the medical field. Deep learning, a subset of AI, has shown great potential in elaborating image analysis. In the field of digestive endoscopy, deep learning has been widely studied, including identifying focal lesions, differentiating malignant and non-malignant lesions, and so on. However, rare study works on automatic photo documentation during endoscopic ultrasound.

Our previous work has successfully developed a deep learning EUS navigation system that can identify the standard stations of the pancreas and CBD in real time. In the present study, we further constructed an EUS automatic image reporting system (EUS-AIRS). The EUS-AIRS can automatically capture images of standard stations, lesions, and biopsy procedures, and label Types of lesions, thereby generating an image report with high completeness and quality during endoscopic ultrasonography.

We tested the performance of the EUS-AIRS by testing its performance on retrospective internal and external data, and we anticipate determining the utility of the EUS-AIRS in clinical practice by testing its performance in consecutive prospective patients.

02

Conditions studied

  • Endoscopic Ultrasonography
  • Artificial Intelligence

Keywords

  • Endoscopic Ultrasonography
  • Artificial Intelligence
03

In context

Lead sponsor

Renmin Hospital of Wuhan University is the lead sponsor of 83 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population was patients undergoing endoscopic ultrasonography who met all inclusion criteria and did not meet all exclusion criteria.

Inclusion criteria

  1. patients aged 18 years or older;
  2. patients with indications for endoscopic ultrasonography of the biliary pancreatic system and undergoing sedated EUS procedures;
  3. ability to read, understand, and sign informed consent;

Exclusion criteria

Exclusion Criteria:

  1. patients with absolute contraindications to EUS examination;
  2. history of previous gastric surgery;
  3. pregnancy;
  4. severe medical illness;
  5. previous medical history of allergic reaction to anesthetics;
  6. stricture or obstruction of the esophagus;
  7. anatomical abnormalities of the upper gastrointestinal tract due to advanced neoplasia.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
114 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. completeness of capturing standard stations

    The number of standard stations correctly captured by EUS-AIRS is divided by the number of all standard stations in the endoscopic ultrasound procedures

    Time frame: 2 months

Secondary outcomes

  1. accuracy of capturing standard stations

    The number of standard station images correctly captured by EUS-AIRS is divided by the number of all standard station images captured by EUS-AIRS

    Time frame: 2 months

  2. completeness of capturing detected lesions

    The number of correct lesions captured by EUS-AIRS was divided by the number of all lesions in the endoscopic ultrasound procedure

    Time frame: 2 months

  3. completeness of capturing biopsy procedures

    The number of correct biopsy procedures captured by EUS-AIRS was divided by the number of all biopsy procedures in the endoscopic ultrasound procedure

    Time frame: 2 months

07

Study locations

1 site
  • Renmin Hospital of Wuhan University
    Wuhan, Hubei Wuhan, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05858827
Lead sponsor
Renmin Hospital of Wuhan University
Responsible party
Sponsor
First posted
May 15, 2023
Start date
May 10, 2023
Primary completion
Oct 23, 2023
Completion
Dec 20, 2023
Last update
Jan 12, 2024

Study contacts

Honggang Yu, Doctor
principal investigator · Renmin Hospital of Wuhan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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