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

NCT06790134 | Recruiting DMC

• 1 other identifier: 2023-EUS-AI-001-2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.A comparison of the image recognition accuracy between the AI system and EUS endoscopists.
2. 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.

Conditions

Pancreatic Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The completeness of anatomical structure scanning

  1 year

• Procedure time

  1 year

• The incidence of adverse events

  1 year

Study Arms (2)

AI-assisted group

EXPERIMENTAL

Endoscopists perform scans with the assistance of AI device.

Device: Artificial intelligence device

Control group

NO INTERVENTION

Endoscopists perform scans without the assistance of AI device.

Interventions

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.

AI-assisted group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead
• First affiliated hospital of Nanhua University: collaborator
• the Affiliated Nanhua Hospital, University of South China: collaborator
• ZhuZhou Central Hospital: collaborator
• First People's Hospital of Chenzhou: collaborator

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, 410000, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Xiaoyan Wang, Doctor

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyan Wang, Doctor

CONTACT

+8613974889301; wangxiaoyan@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: January 15, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 30, 2026
• Last Updated: January 23, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)