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| Name | Class |
|---|---|
| ZhuZhou Central Hospital | OTHER |
| The First Affiliated Hospital of University of South China | OTHER |
| The First People's Hospital of Chenzhou | UNKNOWN |
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The goal of this clinical trial is to verify the auxiliary role of the artificial intelligence (AI) system in mediastinal endoscopic ultrasound (EUS) scans. The main questions it aims to answer are as follows:
Participants will conduct mediastinal EUS with or without the assistance of the AI system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI-assisted group | Experimental | Endoscopists perform scans with the assistance of AI device. |
|
| Control group | Placebo Comparator | Endoscopists perform scans without the assistance of AI device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The completeness of anatomical structure scanning | It calculated as the number of anatomical structures successfully scanned divided by the total number of structures that should have been scanned. | 1 year |
| Procedure time |
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Inclusion Criteria:
1. Age ≥18 years old, <80 years old 2.Patients who need endoscopic ultrasonography; 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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoyan Wang, Doctor | Contact | +8613974889301 | wangxiaoyan@csu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoyan Wang, Doctor | The Third Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410000 | China |
Some data underlying this trial cannot be shared publicly due to protection of participant's privacy.
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| ID | Term |
|---|---|
| D008477 | Mediastinal Diseases |
| ID | Term |
|---|---|
| D013896 | Thoracic Diseases |
| D012140 | Respiratory Tract Diseases |
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| the Affiliated Nanhua Hospital, University of South China |
| UNKNOWN |
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It defined as the observation time only, excluding the time spent on puncture, elastography, contrast-enhanced ultrasound, or other lesion observation or treatment.
| 1 year |
| The incidence of adverse events | The incidence of adverse events in both groups during the entire research process. | 1 year |