Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID06790134

Validation of an AI-Assisted Pancreatic Endoscopic Ultrasound System for Training Improvement in Pancreatic Diseases: A Prospective, Multi-Center, Randomized Trial

Led by The Third Xiangya Hospital of Central South University · Updated on 2025-01-23

200

Participants Needed

1

Research Sites

62 weeks

Total Duration

On this page

Sponsors

T

The Third Xiangya Hospital of Central South University

Lead Sponsor

F

First affiliated hospital of Nanhua University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating an artificial intelligence (AI) system designed to assist pancreatic endoscopic ultrasound (EUS) scans. The study aims to compare the accuracy of image recognition between the AI system and EUS endoscopists, as well as to determine if the AI can improve the quality of scans performed by endoscopists. This is a prospective, multi-center, randomized trial focused on patients needing pancreatic EUS scans. Participants will undergo EUS scanning either with or without the help of the AI device. The AI device provides prompts for standard pancreatic scan sites and anatomical structures, and may also suggest next operation methods to guide the endoscopists during the procedure. This setup allows a direct comparison of scanning quality with and without AI assistance. During the study, researchers will measure the completeness of standard station scanning over one year. Participants will be monitored for the quality and accuracy of the EUS scans, with data collected to assess the AI's auxiliary role. The total participation duration and further procedural details are based on the scanning and follow-up within the study's timeframe.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, but less than 80 years
  • Patients who need endoscopic ultrasonography of the pancreas
  • Agree to participate in this study and sign the informed consent form
Not Eligible

You will not qualify if you...

  • Poor physical condition including hemoglobin ≤8.0g/dl or severe cardiopulmonary insufficiency
  • Failed anesthesia assessment
  • Pregnancy or breastfeeding
  • In the acute stage of chemical or corrosive injury with high risk of perforation
  • Recent acute coronary syndrome or clinically unstable ischemic heart attack
  • Heart disease with right-to-left shunt, severe pulmonary hypertension (pulmonary artery pressure > 90mmHg), uncontrolled systemic hypertension, or adult respiratory distress syndrome
  • Disagree to participate in this study
  • Previous pancreatic surgery, radiotherapy, or chemotherapy
  • Mental illness, drug addiction, inability to express themselves, or other diseases that may affect follow-up or research results

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Third Xiangya Hospital of Central South University

Changsha, China, 410000

Actively Recruiting

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Research Team

X

Xiaoyan Wang, Doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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