Retrograde Cholangiopancreatography AI Assisted System Validation on Effectiveness and Safety
NCT ID: NCT04719117
Last Updated: 2021-01-22
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
150 participants
OBSERVATIONAL
2020-09-01
2021-12-31
Brief Summary
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Detailed Description
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With the popularization of these related technologies, the number of endoscopy increased rapidly, which further increased the workload of endoscopists. The operation of endoscopy by high-load endoscopists would reduce the quality of endoscopy, which is prone to problems such as incomplete examination coverage and incomplete detection of lesions.In digestive endoscopy, there are some problems in China, such as lack of endoscopic physicians and uneven distribution, and the quality of endoscopy is not up to standard. These problems need to be solved urgently in order to relieve the pain of patients, save medical resources, save the time and money of patients, and ensure the quality of patients' medical treatment.
In 2015, the proposal of deep learning brought great changes to the field of artificial intelligence, which made the development of artificial intelligence leap to a new level.Computer vision is a science that studies how to make machines "see". Through deep learning, camera and computer can replace human eyes to carry out machine vision such as target recognition, tracking and measurement.Interdisciplinary cooperation in the field of medical imaging and computer vision is also one of the research hotspots in recent years. At present, it is mainly applied to the automatic identification and detection of lesions and quality control, and has achieved good results. It can assist doctors to find lesions, make disease diagnosis and standardize doctors' operations, so as to improve the quality of doctors' operations.With mature technical support, it has a good prospect and application value to develop endoscopic operating system for lesion detection and quality control based on artificial intelligence methods such as deep learning.
In this study, the investigators proposed a prospective study about the effectiveness of artificial intelligence system for Retrograde cholangiopancreatography. The subjects would be include in an analyses groups. The AI-assisted system helps endoscopic physicians estimate the difficulty of Endoscopic retrograde cholangiopancreatography for choledocholithiasis and make recommendations based on guidelines and difficulty scores. The investigators used the stone removal times, success rate of stone extraction and Operating time to reflect the difficulty of the operation, and evaluated whether the results of the AI system were correct.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Able to read, understand and sign informed consent
* The investigator believes that the subject can understand the process of the clinical study, is willing and able to complete all the study procedures and follow-up visits, and cooperate with the study procedures
* Patients with a natural duodenal papilla
Exclusion Criteria
* Has drug or alcohol abuse or mental disorder in the last 5 years
* Women who are pregnant or lactating
* Subjects with previous biliary sphincterotomy
* The investigator determined that subjects were not suitable for ERCP and related tests
* A high-risk disease or other special condition that the investigator considers inappropriate for the subject to participate in a clinical trial
* Patients with known more severe pancreatic head carcinoma
* Patients with acute pancreatitis within 3 days
* Biliary stent replacement or removal did not occur after pancreatic angiography as expected
* Acute cardiovascular and cerebrovascular diseases
18 Years
ALL
No
Sponsors
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Renmin Hospital of Wuhan University
OTHER
Responsible Party
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Principal Investigators
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Honggang Yu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Wuhan University Renmin Hospital
Locations
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Renmin hospital
Wuhan, Hubei, China
People's Hospital
Shanghai, Shanghai Municipality, China
Changhai Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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Huang L, Xu Y, Chen J, Liu F, Wu D, Zhou W, Wu L, Pang T, Huang X, Zhang K, Yu H. An artificial intelligence difficulty scoring system for stone removal during ERCP: a prospective validation. Endoscopy. 2023 Jan;55(1):4-11. doi: 10.1055/a-1850-6717. Epub 2022 May 12.
Other Identifiers
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EA-19-006-08
Identifier Type: -
Identifier Source: org_study_id
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