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OpenTrials
Completed

NCT Number: NCT05858827

To Evaluate the Capability of an EUS Automatic Image Reporting System

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • patients with absolute contraindications to EUS examination;
  • history of previous gastric surgery;
  • pregnancy;
  • severe medical illness;
  • previous medical history of allergic reaction to anesthetics;
  • stricture or obstruction of the esophagus;
  • anatomical abnormalities of the upper gastrointestinal tract due to advanced neoplasia.

Treatment and study plan

Primary outcomes

  1. completeness of capturing standard stations

    Time frame: 2 months

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

Secondary outcomes

  1. accuracy of capturing standard stations

    Time frame: 2 months

    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

  2. completeness of capturing detected lesions

    Time frame: 2 months

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

  3. completeness of capturing biopsy procedures

    Time frame: 2 months

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

Sponsors and collaborators

Lead sponsor

Renmin Hospital of Wuhan University

Other

Registry information

Official study title

To Evaluate the Capability of an Endoscopic Ultrasonography Automatic Image Reporting System

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 15, 2023
Registry last updated
Jan 12, 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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