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In this study, a single-center, prospective, self-control, and blind design was adopted.
It is planned to enroll 100 patients with solid pancreatic masses who are to be diagnosed with contrast-enhanced harmonic endoscopy ultrasonography (CH-EUS) follow by EUS-guided fine-needle aspiration (EUS-FNA). First, all patients will be diagnosed both by the AI-assisted diagnosis system and the endoscopists under CH-EUS; Second, to compare the EUS-FNA under the guidance of the AI-assisted ultrasound diagnosis system and the EUS-FNA under manual identification, patients were randomly assigned to undergo EUS-FNA with or without the guidance of AI-assisted diagnosis system for the first two passes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the artificial-EUS-FNA group | Experimental | the first two passes were made without the AI-assisted diagnosis system guidance during EUS-FNA, and then two passes were made under guidance from the AI-assisted diagnosis system |
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| the AI-EUS-FNA group | Experimental | the first two passes were made with the AI-assisted diagnosis system guidance and then another two manual passes without the AI-assisted diagnosis system guidance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| artificial-EUS-FNA | Procedure | The ultrasound endoscopists manually determined the region of interest (ROI) according to CH-EUS, and punctured 2 needles in the tumor area with a 22G needle, and each needle moved 15-20 times back and forth in the lesion. After puncture, insert the needle core, rinse the needle with 0.1ml sterile saline, and further apply air flushing to ensure that each tissue is sent to the slide. |
| Measure | Description | Time Frame |
|---|---|---|
| accuracy | compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses | 1 year |
| sensitivity | compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses | 1 year |
| specificity | compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses | 1 year |
| positive predictive value | compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses | 1 year |
| negative predictive value | compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses | 1 year |
| the diagnosis rate of first needle aspiration | compared the diagnosis rate of AI-EUS-FNA and artificial-EUS-FNA first needle aspiration for benign and malignant pancreatic masses | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| core tissue length | To evaluate the specimen quality through core tissue length of AI-EUS-FNA and artificial-EUS-FNA | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
First. The patient's physical condition does not meet the requirements of conventional ultrasound endoscopic puncture:
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 | |
|---|---|---|---|---|
| Wang Xiao, MD | Contact | +8613974889301 | wxy20011@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Tian, MD | The Third Xiangya Hospital of Central South University | Principal Investigator |
| Anliu Tang, MD | 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 | 410013 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36606571 | Derived | Tang A, Tian L, Gao K, Liu R, Hu S, Liu J, Xu J, Fu T, Zhang Z, Wang W, Zeng L, Qu W, Dai Y, Hou R, Tang S, Wang X. Contrast-enhanced harmonic endoscopic ultrasound (CH-EUS) MASTER: A novel deep learning-based system in pancreatic mass diagnosis. Cancer Med. 2023 Apr;12(7):7962-7973. doi: 10.1002/cam4.5578. Epub 2023 Jan 6. |
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| AI-EUS-FNA | Procedure | In the AI-assisted diagnosis system, the assisted targeting EUS-FNA unit is applied, and the ultrasound endoscopist selects the region of interest (ROI) according to the thermogram to perform targeted EUS-FNA puncture(2 needles in the same way). |
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