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

Pancreatic Disease Clinical Trial

Official title:

Clinical Research on Navigation and Quality Control System of Pancreatic Ultrasound Endoscopy Based on Deep Learning

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05792267
• Other study ID #: 2023-EUS-AI-001
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: March 2023
• Source: The Third Xiangya Hospital of Central South University
• Contact: Xiaoyan Wang, Doctor
• Phone: +8613974889301
• Email: wxy20011[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

In this study, a total of 200 cases of 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, compare the image recognition speed, image recognition accuracy and precision of endoscopists with and without the assistance of artificial intelligence system.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Disease
• Pancreatic Diseases

Intervention

Device:
• artificial intelligence system
Patients will undergo EUS examination with the assistance of artificial intelligence(AI) system.

Locations

Country	Name	City	State
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
The Third Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy	The number of correctly classified images divided by the total number of images.	1 year
Primary	intersection over union (IoU)	It was defined as the relative area of overlap between the predicted bounding box(A) and the ground-truth(B) bounding box.	1 year
Primary	Precision	When the IoU was greater than the threshold, the prediction was true positive(TP); when the IoU was less than the threshold, the prediction was false positive(FP). When the model segmentation area was equal to 0, it was false negative(FN).Precision=TP/(TP+FP)	1 year
Primary	Recall	Recall=TP/(TP+FN)	1 year
Primary	Dice	Dice=2TP/(2TP+FP+FN)	1 year
Secondary	Cohen's kappa coefficient.	This data is to evaluate the agreement between the model and the endoscopists.	1 year