Artificial Intelligence Clinical Trial
Official title:
Validation of an Artificial Intelligence-based Biliopancreatic EUS Navigation System for Real-time Quality Improvement: A Prospective, Single-center, Randomized Controlled Trial
Endoscopic ultrasonography (EUS) is a key procedure for diagnosing biliopancreatic diseases. However, the performance among EUS endoscopists varies greatly and leads to blind areas during operation, which impaired the health outcome of patients. We previously developed an artificial intelligence (AI) device that accurately identifies EUS standard stations and significantly reduces the difficulty of ultrasound image interpretation. In this study, we updated the device (named EUS-IREAD) and assessed its performance in improving the quality of EUS examination in a single-center randomized controlled trial.
Status | Recruiting |
Enrollment | 264 |
Est. completion date | July 30, 2023 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Male or female aged 18 or above; 2. Patients able to give informed consent were eligible to participate. 3. Able and willing to comply with all study process. 4. history of previous biliopancreatic disease 5. Biliopancreatic lesions suspected due to clinical symptoms and/or radiological findings and/or laboratory findings 6. Patients at high risk of pancreatic cancer : Known genetic mutations associated with pancreatic cancer risk (BRCA2, BRCA1, PALB2, ATM, CDKNA/p16); Familial pancreatic ductal adenocarcinoma without known germline mutation; Peutz-Jeghers syndrome (STK11); Lynch syndrome (MLH1/MSH2/MSH6, EPCAM, PMS2); Familial adenomatous polyposis (APC). etc. Exclusion Criteria: 1. Has participated in other clinical trials, signed informed consent and was in the follow-up period of other clinical trials. 2. Has participated in clinical trials of the drug and is in the elution period of the experimental drug or control drug. 3. patients with absolute contraindications to EUS examination; 4. Drug or alcohol abuse or psychological disorder in the last 5 years. 5. Patients in pregnancy or lactation. 6. bleeding diathesis or thrombocytopenia 7. history of previous digestive surgery. 8. severe medical illness 9. upper GI tract obstruction 10. previous medical history of allergic reaction to anesthetics 11. anatomical abnormalities of the upper gastrointestinal tract due to advanced neoplasia 12. Researchers believe that the patient is not suitable to participate in the trial. |
Country | Name | City | State |
---|---|---|---|
China | Renmin Hospital of Wuhan University | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Renmin Hospital of Wuhan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Missed scanning rate of standard stations in the experimental group and control group | It was calculated by dividing the number of standard stations that is not scanned by the number of stations that should be scanned. | twelve month | |
Secondary | Missed scanning rate of anatomical landmarks in the experimental group and control groups | It was calculated by dividing the number of anatomical landmarks that is not scanned by the number of anatomical landmarks that should be scanned | twelve month | |
Secondary | Missed scanning rate per standard station | It was calculated by dividing the number of patients who are not scanned at a station by the total number of patients who should be scanned at the station | twelve month | |
Secondary | Missed scanning rate of anatomical landmarks in different standard stations | It was calculated by dividing the number of anatomical landmarks that is not scanned under a station by the number of important anatomical landmarks that should be scanned under that station | twelve month | |
Secondary | Missed scanning rate of standard stations and anatomical landmarks for individual | the Missed scanning rate of standard stations and anatomical landmarks of biliopancreatic endoscopic ultrasonography in different endoscopists in the EUS-IREAD assisted group and control groups | twelve month | |
Secondary | Operation time | In addition to puncture, elastography, enhanced ultrasound and other observation of lesions or treatment, the time used to observe the biliopancreatic system | twelve month |
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