Actively Recruiting
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
Eligibility Criteria
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
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
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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