Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06790134

Validation of an AI-Assisted Pancreatic EUS System for Training Improvement: a Prospective, Multi-Center, Randomized Trial

The goal of this clinical trial is to verify the auxiliary role of the artificial intelligence (AI) system in pancreatic endoscopic ultrasound (EUS) scans. The main questions it aims to answer are as follows:

1. A comparison of the image recognition accuracy between the AI system and EUS endoscopists. 2. Whether the AI system can improve the quality of scans for EUS endoscopists. Participants will conduct EUS scanning with or without the assistance of the AI system.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Third Xiangya Hospital of Central South University

Changsha, 410000, China

Location status: Recruiting

Location contact

Xiaoyan Wang, Doctor

CONTACT

[email protected]

+8613974889301

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age ≥18 years old, <80 years old 2.Patients who need endoscopic ultrasonography of pancreas; 3. Agree to participate in this study and sign the informed consent form.

Exclusion criteria

Subjects who meet any of the following criteria cannot be selected for this trial:

First. The patient's physical condition does not meet the requirements of conventional endoscopic ultrasonography:

Poor physical condition, including hemoglobin ≤8.0g/dl, severe cardiopulmonary insufficiency, etc. Anesthesia assessment failed Pregnancy or breastfeeding In the acute stage of chemical and corrosive injury, it is very easy to cause perforation Recent acute coronary syndrome or clinically unstable ischemic heart attack Heart disease patients with right-to-left shunt, patients with severe pulmonary hypertension (pulmonary artery pressure> 90mmHg), patients with uncontrolled systemic hypertension and patients with adult respiratory distress syndrome.

Second. Disagree to participate in this study.

Third. There are other problems that do not meet the requirements of this research or that affect the results of the research:

Pancreatic disease has undergone surgery or radiotherapy and chemotherapy beforehand; Mental illness, drug addiction, inability to express themselves or other diseases that may affect follow-up.

Treatment and study plan

Artificial intelligence device

Device

This AI device can provide prompts for standard sites of pancreatic scans and anatomical structures. It may also suggest the next operation methods.

Primary outcomes

  1. The completeness for standard station scanning

    Time frame: 1 year

    The primary outcome measure was the completeness for standard station scanning of EUS by endoscopists in the two groups. This was calculated as the number of stations successfully scanned divided by the total number of stations that should have been scanned.

Secondary outcomes

  1. The completeness of anatomical structure scanning

    Time frame: 1 year

    It calculated as the number of anatomical structures successfully scanned divided by the total number of structures that should have been scanned.

  2. Procedure time

    Time frame: 1 year

    It defined as the observation time only, excluding the time spent on puncture, elastography, contrast-enhanced ultrasound, or other lesion observation or treatment.

  3. The incidence of adverse events

    Time frame: 1 year

    The incidence of adverse events in both groups during the entire research process.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoyan Wang, Doctor

CONTACT

[email protected]

+8613974889301

Sponsors and collaborators

Lead sponsor

The Third Xiangya Hospital of Central South University

Other

Collaborators

  • First People's Hospital of Chenzhou
  • First affiliated hospital of Nanhua University
  • ZhuZhou Central Hospital
  • the Affiliated Nanhua Hospital, University of South China

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 23, 2025
Registry last updated
Jan 23, 2025

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.

Published trials that share one or more normalized conditions with this study.