Clinical Research on a Novel Deep-learning Based System in Pancreatic Mass Diagnosis
NCT ID: NCT04607720
Last Updated: 2020-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2020-01-01
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
DOUBLE
Study Groups
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the artificial-EUS-FNA group
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
artificial-EUS-FNA
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.
AI-EUS-FNA
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).
the AI-EUS-FNA group
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.
artificial-EUS-FNA
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.
AI-EUS-FNA
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).
Interventions
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artificial-EUS-FNA
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.
AI-EUS-FNA
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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
First. The patient's physical condition does not meet the requirements of conventional ultrasound endoscopic puncture:
1. Poor physical condition, including hemoglobin ≤8.0g/dl, severe cardiopulmonary insufficiency, etc.
2. Blood coagulation dysfunction (platelet count \<50×1012, international standardized ratio\> 1.5) or taking oral anticoagulants such as aspirin or warfarin within a week
3. Anesthesia assessment failed
4. Had acute pancreatitis within 2 weeks
5. Pregnancy or breastfeeding
6. Known history of allergy to sulfur hexafluoride or other components
7. Recent acute coronary syndrome or clinically unstable ischemic heart attack
8. 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 chemotherapy beforehand
2. The patient was diagnosed with pancreatic cystic disease or duodenal stenosis
3. Mental illness, drug addiction, inability to express themselves or other diseases that may affect follow-up
18 Years
90 Years
ALL
No
Sponsors
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The Third Xiangya Hospital of Central South University
OTHER
Responsible Party
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Principal Investigators
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Li Tian, MD
Role: PRINCIPAL_INVESTIGATOR
The Third Xiangya Hospital of Central South University
Anliu Tang, MD
Role: PRINCIPAL_INVESTIGATOR
The Third Xiangya Hospital of Central South University
Locations
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The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2020-CH-EUS-AI
Identifier Type: -
Identifier Source: org_study_id