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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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (予想される)

150

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Patients who meet the admission criteria for endoscopic examination.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:他の
  • 時間の展望:見込みのある

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Number of stone removal operations
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
the accuracy of the measurement
時間枠: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
時間枠:A year
Whether the stones have been removed successfully
A year
the sensitivity of the prediction of the stone
時間枠: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
時間枠: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
時間枠:During surgery
Refers to the time from the successful intubation of the duodenal papilla guide wire to the beginning of endoscopic withdrawal.
During surgery

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Honggang Yu, Doctor、Wuhan University Renmin Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2020年9月1日

一次修了 (予想される)

2021年7月1日

研究の完了 (予想される)

2021年12月31日

試験登録日

最初に提出

2021年1月15日

QC基準を満たした最初の提出物

2021年1月20日

最初の投稿 (実際)

2021年1月22日

学習記録の更新

投稿された最後の更新 (実際)

2021年1月22日

QC基準を満たした最後の更新が送信されました

2021年1月20日

最終確認日

2021年1月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • EA-19-006-08

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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