Status:
UNKNOWN
Effectiveness of an Ai-based Endoscopic Ultrasound Navigation System in the Training of Endoscopic Ultrasonics
Lead Sponsor:
Renmin Hospital of Wuhan University
Conditions:
Endoscopic Ultrasound
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In the early stage, the investigators successfully constructed an artificial intelligence model-based ultrasonic endoscopy-assisted film reading system and named the modified system biliopancreatic Ma...
Detailed Description
Endoscopic ultrasonography is essential for diagnosing and treating biliary and pancreatic diseases. The total incidence of biliary and pancreatic diseases is as high as 121/100,000, causing about 14....
Eligibility Criteria
Inclusion
- Endoscopist:
- Endoscopists with experience in performing more than 300 gastroscopies; Lack of experience in independently operating an endoscopic ultrasound (EUS); No experience in EUS-guided fine-needle aspiration biopsy (FNA).
- Patient:
- Patient age ≥18 years; Patients who consecutively undergo sedated EUS procedures; Ability to read, understand, and sign the informed consent; Patients suspected of having biliary (both pancreatic and biliary) lesions based on clinical symptoms and/or radiological findings and/or laboratory test results; High-risk patients for pancreatic cancer: known genetic mutations associated with the risk of pancreatic cancer (BRCA2, BRCA1, PALB2, ATM, CDKNA/p16); familial pancreatic ductal adenocarcinoma with no known lineage mutations; Peutz-Jeghers syndrome (STK11); Lynch syndrome (MLH1/MSH2/MSH6, EPCAM, PMS2); familial adenomatous polyposis (APC) etc. Based on the preoperative cholangiopancreatography report, patients are classified into those with or without radiological findings. Patients with radiological findings are categorized by lesion location, such as the pancreas, PD, CBD, and other lesions (like gallbladder, duodenal papilla suspected of biliary invasion).
Exclusion
- Patients with absolute contraindications to EUS examination; Previous gastric surgery; Pregnancy; Severe internal medical diseases; History of allergy to anesthesia drugs; Esophageal narrowing or obstruction; Upper gastrointestinal anatomical abnormalities caused by advanced tumors.
Key Trial Info
Start Date :
October 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05421520
Start Date
October 8 2023
End Date
May 31 2024
Last Update
August 24 2023
Active Locations (2)
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1
The Eighth Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong, China, 518066
2
Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430060