| 目的/Objectives |
| 目的1/Narrative objectives1 |
この国際多施設研究では、人工知能によるリアルタイム大腸ポリープ診断支援システム（EndoBRAIN, サイバーネットシステム株式会社）の、大腸ポリープ診断における実臨床ベースでの有用性を検証する。 |
This international multicenter accuracy trial investigates the diagnostic performance of the real-time artificial intelligence system (EndoBRAIN, Cybernet Systems, Corp. Tokyo) for diagnosis of colorectal polyps in real-World colonoscopy. |
| 目的2/Basic objectives2 |
安全性・有効性/Safety,Efficacy |
| 目的2 -その他詳細/Basic objectives -Others |
|
|
| 試験の性質1/Trial characteristics_1 |
|
| 試験の性質2/Trial characteristics_2 |
|
| 試験のフェーズ/Developmental phase |
|
| 評価/Assessment |
| 主要アウトカム評価項目/Primary outcomes |
EndoBRAINが直腸S状結腸の微小腺腫診断における感度を、内視鏡医単独診断よりも上昇させるかどうかを評価することである。 |
To compare the sensitivity of identifying diminutive colorectal polyps as adenomas during colonoscopy with the combination of visual inspection and the use of the EndoBRAIN technology to visual inspection alone. |
| 副次アウトカム評価項目/Key secondary outcomes |
1.直腸S状部の微小腺腫診断における特異度の比較（内視鏡医 vs 内視鏡医+EndoBRAIN）
2.EndoBRAINを利用した場合の包括的診断能（感度・特異度・陽性反応的中率・陰性反応的中率）
3.EndoBRAINを利用した場合の包括的診断能が、米国内視鏡学会が提唱する診断閾値（PIVI-1およびPIVI-2）を上回ることの検証
4.超拡大内視鏡画像の取得率
5. 内視鏡医+EndoBRAINと内視鏡医単独の場合の高確信度診断の割合の比較
6. 超拡大内視鏡による盲腸挿入率・挿入時間・合併症の評価。
|
1. To compare the specificity of identifying diminutive colorectal polyps as adenomas during colonoscopy with the combination of visual inspection and the use of the EndoBRAIN CAD technology to visual inspection alone.
2. To estimate the sensitivity, specificity, positive predictive value, and negative predictive value of the combination of visual inspection and the use of the EndoBRAIN CAD technology
3. To assess whether the diagnostic performance of the combination of visual inspection and the use of the EndoBRAIN CAD technology of endoscopists meets the PIVI-1 and PIVI-2 guideline recommendations for diagnostic performance of the American Society of Gastrointestinal Endoscopy (ASGE)12: >90% accuracy in predicting post-polypectomy surveillance intervals based on optical biopsy with high confidence (PIVI-1*); >90% NPV in identifying rectosigmoid diminutive adenomas based on optical biopsy with high confidence (PIVI-2)6.
4. To estimate the percentage of diminutive colorectal polyps from which endocytoscopic images can be successfully captured (acquisition rate).
5. To estimate the rate of high-confidence diagnosis with EndoBRAIN as compared to visual polyp inspection alone.
6. To evaluate the colonoscopy performance with an endocytoscope including the EndoBRAIN device with regard to cecal intubation rate, insertion time, and complications.
|
| 介入/Intervention |
| 群数/No. of arms |
1 |
| 介入の目的/Purpose of intervention |
診断/Diagnosis |
| 介入の種類/Type of intervention |
|
| 介入1/Interventions/Control_1 |
EndoBRAINを用いた診断。
（本試験では、実臨床に比較して侵襲的な介入はない） |
Diagnosis using EndoBRAIN.
(The present study does not require additional invasive interventions as compared to clinical practice. ) |
| 介入2/Interventions/Control_2 |
|
|
| 介入3/Interventions/Control_3 |
|
|
| 介入4/Interventions/Control_4 |
|
|
| 介入5/Interventions/Control_5 |
|
|
| 介入6/Interventions/Control_6 |
|
|
| 介入7/Interventions/Control_7 |
|
|
| 介入8/Interventions/Control_8 |
|
|
| 介入9/Interventions/Control_9 |
|
|
| 介入10/Interventions/Control_10 |
|
|
| 適格性/Eligibility |
| 年齢（下限）/Age-lower limit |
|
| 年齢（上限）/Age-upper limit |
|
| 性別/Gender |
男女両方/Male and Female |
| 選択基準/Key inclusion criteria |
18才以上で、大腸内視鏡検査目的(スクリーニング・サーベイランス・診断・および治療目的)に来院した患者で、5mm以下の微小大腸ポリープが直腸S状結腸に発見された患者。 |
Individuals 18 years or older who are scheduled for screening, surveillance, diagnostic, or therapeutic colonoscopy at the trial centres with diminutive rectosigmoid polyps (<=5mm).
|
| 除外基準/Key exclusion criteria |
１．病理診断が判明している微小ポリープ
２．炎症性腸疾患
３．ポリポーシス患者（familial adenomatous polyposis, serrated polyposisなど）
４．大腸腫瘍に対する化学療法や放射線療法の既往
５．ポリープ切除ができない状況（抗凝固薬を内服中・全身状態悪化・患者拒否など）
６．妊娠 |
1. Diminutive polyps with known histology
2. Inflammatory bowel disease
3. Polyposis syndrome (e.g., familial adenomatous polyposis, serrated polyposis)
4. History of chemotherapy or radiation therapy for colorectal lesions
5. Inability to undergo polypectomy (e.g. intake of anticoagulants, comorbidities, or patient refusal)
6. Pregnancy
|
| 目標参加者数/Target sample size |
345 |
| 責任研究者/Research contact person |
| 責任研究者/Name of lead principal investigator |
| 名 |
Oyvind Holme; Michael Bretthauer;Yuichi Mori (PIs) |
| ミドルネーム |
|
| 姓 |
Amyn Haji; Shin-ei Kudo (co-PIs) |
|
| 名 |
Oyvind Holme; Michael Bretthauer;Yuichi Mori (PIs) |
| ミドルネーム |
|
| 姓 |
Amyn Haji; Shin-ei Kudo (co-PIs) |
|
| 所属組織/Organization |
Oslo University Hospital/University of Oslo, Oslo (OH; MB)
Showa University Northern Yokohama Hospital/Showa University, Tokyo (YM)
King's college hospital, London (AH)
|
Oslo University Hospital/University of Oslo, Oslo (OH; MB)
Showa University Northern Yokohama Hospital/Showa University, Tokyo (YM; SK)
King's college hospital, London (AH)
|
| 所属部署/Division name |
Clinical Effectiveness Research Group(OH; MB); Digestive Disease Center (YM, SK); Endoscopy & Colorectal Surgery (AH) |
Clinical Effectiveness Research Group(OH; MB); Digestive Disease Center (YM, SK); Endoscopy & Colorectal Surgery (AH) |
| 郵便番号/Zip code |
x |
| 住所/Address |
Sognsvannsveien 21 0372 Oslo (OH; MB); 35-1, Chigasaki-tyuo, Tsuzuki-ku, Yokohama (YM, SK); Denmark Hill, London (AH) |
Sognsvannsveien 21 0372 Oslo (OH; MB); 35-1, Chigasaki-tyuo, Tsuzuki-ku, Yokohama (YM, SK); Denmark Hill, London (AH); Denmark Hill, London |
| 電話/TEL |
+47-22850550(+81-459497000)(+44-2032999000) |
| Email/Email |
oyvind.holme@medisin.uio.no |
| IRB等連絡先（公開）/IRB Contact (For public release) |
| 組織名/Organization |
Showa University Northern Yokohama Hospital; Regonale Komiteer For Medisinsk Og Helsefaglig Forskningsetikk |
Showa University Northern Yokohama Hospital; Regonale Komiteer For Medisinsk Og Helsefaglig Forskningsetikk |
| 住所/Address |
35-1, Chigasaki-tyuo, Tsuzuki-ku, Yokohama; Gullhaugveien 1-3, 0484 Oslo |
35-1, Chigasaki-tyuo, Tsuzuki-ku, Yokohama; Gullhaugveien 1-3, 0484 Oslo |
| 電話/Tel |
+81459497000; +4722857547 |
| Email/Email |
irb02syh@ofc.showa-u.ac.jp post@helseforskning.etikkom.no |
| 結果/Result |
| 結果掲載URL/URL related to results and publications |
NA |
| 組み入れ参加者数/Number of participants that the trial has enrolled |
1242 |
| 主な結果/Results |
To be disclosed after publication. |
To be disclosed after publication. |
| 主な結果入力日/Results date posted |
|
| 結果掲載遅延/Results Delayed |
|
| 結果遅延理由/Results Delay Reason |
|
|
| 最初の試験結果の出版日/Date of the first journal publication of results |
|
| 参加者背景/Baseline Characteristics |
To be disclosed after publication. |
To be disclosed after publication. |
| 参加者の流れ/Participant flow |
To be disclosed after publication. |
To be disclosed after publication. |
| 有害事象/Adverse events |
To be disclosed after publication. |
To be disclosed after publication. |
| 評価項目/Outcome measures |
To be disclosed after publication. |
To be disclosed after publication. |
| 個別症例データ共有計画/Plan to share IPD |
|
|
| 個別症例データ共有計画の詳細/IPD sharing Plan description |
|
|
UMIN-CTR 臨床試験登録情報の閲覧