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Retrograde Cholangiopancreatography AI Assisted System Validation on Effectiveness and Safety

2021年1月20日 更新者:Renmin Hospital of Wuhan University

A Multicentric Validation Study on the Effectiveness and Safety of Artificial Intelligence Assisted System in Clinical Application of Retrograde Cholangiopancreatography

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.

研究概览

详细说明

Endoscopy is a routine and reliable method for the diagnosis of digestive tract diseases.Common endoscopy are gastroscopy, colonoscopy, capsule endoscopy and enteroscopy, ultrasonic gastroscopy, after ercp and other related technology, can be used in early gastric cancer and peptic ulcer, esophageal varices, the stomach before lesion, intestinal polyps and adenomas and colorectal lesions, inflammatory bowel disease, pancreas disease, biliary tract disease diagnosis and follow-up.At present, digestive endoscopy almost covers the diagnosis of the vast majority of diseases of the digestive tract, and diseases of the digestive system that cannot be directly seen by endoscopy can also be realized through endoscopic-based technologies such as endoscopy and ERCP (here the investigators collectively refer to endoscopy), so as to achieve the coverage of the whole digestive system.It can be seen that digestive endoscopy is of great significance for the diagnosis of digestive diseases and the development of digestive field.

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.

研究类型

观察性的

注册 (预期的)

150

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Hubei
      • Wuhan、Hubei、中国、430000
        • Renmin Hospital
    • Shanghai
      • Shanghai、Shanghai、中国、200433
        • Changhai Hospital
      • Shanghai、Shanghai、中国、200072
        • People'S Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients who meet the admission criteria for endoscopic examination.

描述

Inclusion Criteria:

  • Who needs ERCP and its related tests are needed to further define the characteristics of digestive tract diseases
  • 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 participated in other clinical trials, signed informed consent and is in the follow-up period of other clinical trials
  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:其他
  • 时间观点:预期

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of stone removal operations
大体时间:A year
The number of times that the stoning balloon and the stoning net were pulled out of the lumen during the stoning process.
A year

次要结果测量

结果测量
措施说明
大体时间
the accuracy of the measurement
大体时间:A year
The diameter of the stone (or the width of the lower end of the bile duct) measured by the machine is consistent with the doctor's degree.Accurate DuDu = | machine measurement results - the doctor gold standard measurement results | / doctor gold standard measurements.
A year
Stone clearance success rate
大体时间:A year
Whether the stones have been removed successfully
A year
the sensitivity of the prediction of the stone
大体时间:A year
That is, the sensitivity of the machine to predict the number of stones.Sensitivity = the number of calculi correctly predicted by the machine/the number of actual calculi.
A year
the operate time
大体时间:During surgery
Refers to the time from the successful intubation of the duodenal papilla guide wire to the beginning of endoscopic withdrawal.
During surgery
the removal stone time
大体时间:During surgery
Refers to the time from the successful intubation of the duodenal papilla guide wire to the beginning of endoscopic withdrawal.
During surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Honggang Yu, Doctor、Wuhan University Renmin Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年9月1日

初级完成 (预期的)

2021年7月1日

研究完成 (预期的)

2021年12月31日

研究注册日期

首次提交

2021年1月15日

首先提交符合 QC 标准的

2021年1月20日

首次发布 (实际的)

2021年1月22日

研究记录更新

最后更新发布 (实际的)

2021年1月22日

上次提交的符合 QC 标准的更新

2021年1月20日

最后验证

2021年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • EA-19-006-08

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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