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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Diseases
• Intervention / Treatment: Device: Artificial intelligence device

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoyan Wang, Doctor; Phone Number: +8613974889301; Email: wangxiaoyan@csu.edu.cn

Study Locations

• China
  • Changsha, China, 410000
    • Recruiting
    • The third Xiangya Hospital of Central South University
    • Contact: Xiaoyan Wang, Doctor; Phone Number: +8613974889301; Email: wangxiaoyan@csu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI-assisted group; Endoscopists perform scans with the assistance of AI device.	Device: Artificial intelligence device; This AI device can provide prompts for standard sites of pancreatic scans and anatomical structures. It may also suggest the next operation methods.
No Intervention: Control group; Endoscopists perform scans without the assistance of AI device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The completeness for standard station scanning	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The completeness of anatomical structure scanning	It calculated as the number of anatomical structures successfully scanned divided by the total number of structures that should have been scanned.	1 year
Procedure time	It defined as the observation time only, excluding the time spent on puncture, elastography, contrast-enhanced ultrasound, or other lesion observation or treatment.	1 year
The incidence of adverse events	The incidence of adverse events in both groups during the entire research process.	1 year

Collaborators and Investigators

• Sponsor: The Third Xiangya Hospital of Central South University
• Collaborators: ZhuZhou Central Hospital; First People's Hospital of Chenzhou; the Affiliated Nanhua Hospital, University of South China; First affiliated hospital of Nanhua University
• Investigators: Principal Investigator: Xiaoyan Wang, Doctor, The third Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases
• Other Study ID Numbers: 2023-EUS-AI-001-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Some data underlying this trial cannot be shared publicly due to protection of participant's privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No