Pancreatobiliary diseases
Conditions
Interventions
AI-assisted training group:trainees received traditional hands-on mentorship combined with real-time assistance from an artificial intelligence (AI) system
Conventional training group:rainees received traditional hands-on mentorship only
Sponsors
Renmin Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria for Endoscopic Ultrasound (EUS) Endoscopists: (1) At least 3 years of experience in performing gastrointestinal endoscopy; (2) Fewer than 25 independent EUS procedures performed; (3) No prior experience in performing EUS-guided fine-needle aspiration (EUS-FNA); (4) Willingness to participate in the study and provision of written informed consent. Inclusion Criteria for Patients: (1) Male or female patients aged =18 years; (2) Ability to read, understand, and sign the informed consent form; (3) Clinical indication for undergoing endoscopic ultrasonography for diagnosis or evaluation; (4) Considered by the investigator to be capable of understanding the clinical study procedures and willing and able to complete all study-related procedures and follow-up visits in accordance with the study protocol.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for Endoscopic Ultrasound (EUS) Endoscopists: (1) Senior EUS endoscopists who have already mastered independent EUS operation skills; (2) Endoscopists unable to complete the training or observation procedures due to personal reasons. Exclusion Criteria for Patients: (1) Participation in another clinical trial, having signed an informed consent form, and still being within the follow-up period of that trial; (2) Participation in a drug clinical trial and currently within the washout period of the investigational or control drug; (3) Presence of absolute contraindications to endoscopic ultrasonography; (4) History of substance or alcohol abuse, or psychiatric disorders within the past five years; (5) Pregnant or lactating women; (6) Increased bleeding risk or thrombocytopenia; (7) History of gastrointestinal surgery; (8) Presence of severe internal medical diseases; (9) Upper gastrointestinal obstruction; (10) History of allergic reactions to anesthetic agents; (11) Anatomical abnormalities of the upper gastrointestinal tract caused by advanced malignancies; (12) Determination by the investigator that the subject is unsuitable for EUS examination; (13) Determination by the investigator that the subject has high-risk conditions or special circumstances that make participation in the clinical trial inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Competency rate of the Global Overall Assessment (GOA); | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of key procedural steps;Learning curve;Procedure time;Lesion detection sensitivity;Safety; | — |
Countries
China
Contacts
Public ContactYu Honggang
Renmin Hospital of Wuhan University
Outcome results
None listed