The Third Xiangya Hospital of Central South University
Changsha, 410000, China
Location status: Recruiting
NCT Number: NCT06790134
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. A comparison of the image recognition accuracy between the AI system and EUS endoscopists. 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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Changsha, 410000, China
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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:
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.
This AI device can provide prompts for standard sites of pancreatic scans and anatomical structures. It may also suggest the next operation methods.
Time frame: 1 year
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.
Time frame: 1 year
It calculated as the number of anatomical structures successfully scanned divided by the total number of structures that should have been scanned.
Time frame: 1 year
It defined as the observation time only, excluding the time spent on puncture, elastography, contrast-enhanced ultrasound, or other lesion observation or treatment.
Time frame: 1 year
The incidence of adverse events in both groups during the entire research process.
Contact information is provided by the study sponsor or research team.
The Third Xiangya Hospital of Central South University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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