Validation of an AI-based Biliopancreatic EUS Navigation System for Real-time Quality Improvement: A Prospective, Single-center, Randomized Controlled Trial
Validation of an Artificial Intelligence-based Biliopancreatic EUS Navigation System for Real-time Quality Improvement: A Prospective, Single-center, Randomized Controlled Trial
1 other identifier
interventional
264
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2022
CompletedFirst Submitted
Initial submission to the registry
July 9, 2022
CompletedFirst Posted
Study publicly available on registry
July 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2023
CompletedJune 22, 2023
July 1, 2022
1 year
July 9, 2022
June 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Missed scanning rate of anatomical landmarks in the experimental group and control groups
twelve month
Missed scanning rate per standard station
twelve month
Missed scanning rate of anatomical landmarks in different standard stations
twelve month
Missed scanning rate of standard stations and anatomical landmarks for individual
twelve month
Operation time
twelve month
Study Arms (2)
with AI-based biliopancreatic EUS navigation system
EXPERIMENTALThe endoscopists in the experimental group will be assisted by EndoAngel, which can in real-time prompt standard stations and anatomical structures during EUS.
without AI-based biliopancreatic EUS navigation system
NO INTERVENTIONThe endoscopists in the contrpl group performs the examination routinely without special prompts.
Interventions
The endoscopists in the experimental group will be assisted by EndoAngel, which can in real-time prompt standard stations and anatomical structures during EUS. The system is an non-invasive AI system .
Eligibility Criteria
You may qualify if:
- Male or female aged 18 or above;
- Patients able to give informed consent were eligible to participate.
- Able and willing to comply with all study process.
- history of previous biliopancreatic disease
- Biliopancreatic lesions suspected due to clinical symptoms and/or radiological findings and/or laboratory findings
- 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.
You may not qualify if:
- Has participated in other clinical trials, signed informed consent and was in the follow-up period of other clinical trials.
- Has participated in clinical trials of the drug and is in the elution period of the experimental drug or control drug.
- patients with absolute contraindications to EUS examination;
- Drug or alcohol abuse or psychological disorder in the last 5 years.
- Patients in pregnancy or lactation.
- bleeding diathesis or thrombocytopenia
- history of previous digestive surgery.
- severe medical illness
- upper GI tract obstruction
- previous medical history of allergic reaction to anesthetics
- anatomical abnormalities of the upper gastrointestinal tract due to advanced neoplasia
- Researchers believe that the patient is not suitable to participate in the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Related Publications (1)
Wu HL, Yao LW, Shi HY, Wu LL, Li X, Zhang CX, Chen BR, Zhang J, Tan W, Cui N, Zhou W, Zhang JX, Xiao B, Gong RR, Ding Z, Yu HG. Validation of a real-time biliopancreatic endoscopic ultrasonography analytical device in China: a prospective, single-centre, randomised, controlled trial. Lancet Digit Health. 2023 Nov;5(11):e812-e820. doi: 10.1016/S2589-7500(23)00160-7. Epub 2023 Sep 27.
PMID: 37775472DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Honggang Yu, Doctor
Renmin Hospital of Wuhan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2022
First Posted
July 13, 2022
Study Start
July 1, 2022
Primary Completion
July 1, 2023
Study Completion
July 30, 2023
Last Updated
June 22, 2023
Record last verified: 2022-07