Artificial Intelligence Identifying Polyps in Real-world Colonoscopy
2018年12月14日 更新者:Zhaoshen Li
Validating the Performance of Artificial Intelligence in Identifying Polyps in Real-world Colonoscopy
Recently, artificial intelligence (AI) assisted image recognition has made remarkable breakthroughs in various medical fields with the developing of deep learning and conventional neural networks (CNNs).
However, all current AI assisted-diagnosis systems (ADSs) were established and validated on endoscopic images or selected videos, while its actual assisted-diagnosis performance in real-world colonoscopy is up to now unknown.
Therefore, we validated the performance of an ADS in real-world colonoscopy, which is based on deep learning algorithm and CNNs, trained and tested in multicenter datasets of 20 endoscopy centers.
調査の概要
状態
完了
条件
詳細な説明
The ADS were established in changhai digestive endoscopy center to assess its efficacy in clinical practice.
The ADS automatically initiated once the ileocecal valve was pictured by the colonoscopist or the colonoscopist recorded any image of colon during the insertion.
When colonoscopists withdrew the colonoscopies and inspect the colons, the video streaming of colonoscopies was real-time switched to the ADS, which made it feasible to identify and classify lesions in real time.
Colonoscopists were invited to respond if they doubted potential polyps in the screen, and the ADS also made a voice when identifying potential polyps, followed by repeatedly inspecting to confirm the existence of lesions.
The voice of ADS could be real-time heard by colonoscopists, while the screen of ADS was placed right behind colonoscopists, where polyps identified by ADS could be seen after the colonoscopists' turning but not simultaneously.
The lesion detection by ADS or colonoscopists were determined as follow: A. polyps only identified by ADS, which was considered to be missed by colonoscopists: polyps were reported by the ADS and the colonoscopists did not know the location of polyps without reminder of the ADS until the polyps disappeared from the view; B. polyps first identified by ADS: polyps were first reported by the ADS and the colonoscopists also later knew the location of polyps by themselves; C. polyps simultaneously identified by the ADS and colonoscopists: the time of reporting polyps was closely synchronal (within 1 second); D. polyps first reported by colonoscopists: polyps were first reported by the colonoscopists and the ADS also later identified the location of polyps before the colonoscopists unfolded and pictured the polyps; E. polyps only reported by colonoscopists, which was considered to be missed by the ADS: polyps were reported by the colonoscopists and the ADS did not identify the location of polyps until colonoscopists unfolded and pictured the polyps.
Besides, the false-positives of real-world ADS were also reported with potential causes analyzed by colonoscopists.
研究の種類
観察的
入学 (実際)
209
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
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Shanghai、中国、200433
- Changhai Hospital, Second Military Medical University
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Shanghai、中国、200433
- Changhai Hospital
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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~75年 (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
consecutive outpatient who recieved colonoscopy
説明
Inclusion Criteria:
- patients receiving screening colonoscopy
- patients receiving surveillance colonoscopy
- patients receiving diagnostic colonoscopy
Exclusion Criteria:
- patients with declined consent
- patients with poor bowel preparation
- patients with failed cecal intubation
- patients with colonic resection
- patients with inflammatory bowel diseases
- patients with polyposis
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:ケースのみ
- 時間の展望:見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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colonoscopy withdrawal with the ADS monitoring
The ADS automatically initiated once the ileocecal valve was pictured by the colonoscopist or the colonoscopist recorded any image of colon during the insertion.
When colonoscopists withdrew the colonoscopies and inspect the colons, the video streaming of colonoscopies was real-time switched to the ADS, which made it feasible to identify and classify lesions in real time.
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During the testing of trained ADS, when the system doubts colonic lesions from the input data of the test images, a rectangular frame was displayed in the endoscopic image to surround the lesion.
If the system confirmed it as the colonic lesions, a sound of reminder will be played and the types of lesions (non-adenomatous polyps, adenomatous polyps and colorectal cancers) will be classified by the system.
We adopted several standards to define the identification and classification of colonic lesions: 1) when the system identified and confirmed any lesion in the images of no polyps or cancers, the results were judged to be false-positive.
2) when the system both confirmed and correctly localized the lesions in images (IoU > 0.3), the results were judged to be true-positive.
3) when the system did not confirm or correctly localize the lesions, the results were judged as false-negative.
4) when system confirmed no lesions in the normal images, the results were judged to be true-negative.
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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 |
|---|---|---|
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sensitivity of the ADS in identifying polyps
時間枠:1 hour
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Polyps that were only reported by colonoscopists were considered to be missed by the ADS (polyps were reported by the colonoscopists and the ADS did not identify the location of polyps until colonoscopists unfolded and pictured the polyps.)
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1 hour
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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false positves of the ADS per colonoscopy withdrawal
時間枠:1 hour
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when the system identified and confirmed any lesion in the images with no polyps or cancers appearing, the results were judged to be false-positive.
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1 hour
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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。
スポンサー
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。
一般刊行物
- Byrne MF, Chapados N, Soudan F, Oertel C, Linares Perez M, Kelly R, Iqbal N, Chandelier F, Rex DK. Real-time differentiation of adenomatous and hyperplastic diminutive colorectal polyps during analysis of unaltered videos of standard colonoscopy using a deep learning model. Gut. 2019 Jan;68(1):94-100. doi: 10.1136/gutjnl-2017-314547. Epub 2017 Oct 24.
- Wang Z, Meng Q, Wang S, Li Z, Bai Y, Wang D. Deep learning-based endoscopic image recognition for detection of early gastric cancer: a Chinese perspective. Gastrointest Endosc. 2018 Jul;88(1):198-199. doi: 10.1016/j.gie.2018.01.029. No abstract available.
- Urban G, Tripathi P, Alkayali T, Mittal M, Jalali F, Karnes W, Baldi P. Deep Learning Localizes and Identifies Polyps in Real Time With 96% Accuracy in Screening Colonoscopy. Gastroenterology. 2018 Oct;155(4):1069-1078.e8. doi: 10.1053/j.gastro.2018.06.037. Epub 2018 Jun 18.
- Wang Z, Zhao S, Bai Y. Artificial Intelligence as a Third Eye in Lesion Detection by Endoscopy. Clin Gastroenterol Hepatol. 2018 Sep;16(9):1537. doi: 10.1016/j.cgh.2018.04.032. No abstract available.
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)
2018年11月1日
一次修了 (実際)
2018年12月10日
研究の完了 (実際)
2018年12月10日
試験登録日
最初に提出
2018年11月30日
QC基準を満たした最初の提出物
2018年11月30日
最初の投稿 (実際)
2018年12月3日
学習記録の更新
投稿された最後の更新 (実際)
2018年12月17日
QC基準を満たした最後の更新が送信されました
2018年12月14日
最終確認日
2018年12月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- AI-1
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
米国で製造され、米国から輸出された製品。
いいえ
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