Clinical Research on a Novel Deep-learning Based System in Pancreatic Endoscopic Ultrasound Scanning

Central South University

Status: Enrolling

Conditions: Pancreatic Disease

Treatments: Device: artificial intelligence system

Study type: Interventional

Funder types: Other

Identifiers

NCT05792267

2023-EUS-AI-001

Details and patient eligibility

About

The goal of this clinical trial is to develop and verify the auxiliary role of the artificial intelligence system in pancreatic ultrasound endoscopic scanning.The main questions it aims to answer are as follows: 1.The comparison of the image recognition accuracy between the artificial intelligence system and the ultrasound endoscopist; 2. Whether the artificial intelligence system can improve the efficiency of the pancreatic scanning for the ultrasound endoscopist. Participants will undergo pancreatic EUS with or without the assistance of the artificial intelligence system.

Full description

In this study, pancreatic endoscopic ultrasound scanning videos and images will be collected. First of all, an artificial intelligence system based on deep learning for the navigation and quality control of pancreatic endoscopic ultrasonography will be established. Secondly, the artificial intelligence system will be used to identify the site and anatomical structure of the pancreatic ultrasound endoscopy, and the results of the artificial intelligence system's station recognition will be compared with the results of the endoscopist's station recognition. Finally, the completeness of standard sites and scanning time of endoscopic-assisted and non-assisted AI systems were compared.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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:

1. Poor physical condition, including hemoglobin ≤8.0g/dl, severe cardiopulmonary insufficiency, etc.
2. Anesthesia assessment failed
3. Pregnancy or breastfeeding
4. In the acute stage of chemical and corrosive injury, it is very easy to cause perforation
5. Recent acute coronary syndrome or clinically unstable ischemic heart attack
6. 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:

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

AI-assisted group

Experimental group

Description:

Subjects will undergo EUS examination with the assistance of artificial intelligence(AI) system.

Treatment:

Device: artificial intelligence system

Non-assisted group

No Intervention group

Description:

Subjects will undergo EUS examination without the assistance of artificial intelligence(AI) system.