Evaluation of Versatile Intelligent Staining Technology (VIST) and Spectral Flexible Imaging (SFI) for Detection and Optical Characterization of Colorectal Lesions: A Prospective Randomized Controlled Study (INSIGHT)
2026年8月26日 更新者：Alexandre Vontobel Padoin
Evaluation of Versatile Intelligent Staining Technology (VIST) and Spectral Flexible Imaging (SFI) for Detection and Optical Characterization of Colorectal Lesions: A Prospective Randomized Controlled Study (INSIGHT Study)
This prospective randomized controlled study aims to evaluate the diagnostic accuracy of Versatile Intelligent Staining Technology (VIST) and Spectral Flexible Imaging (SFI) for detection and optical characterization of colorectal lesions during colonoscopy.
The performance of VIST and SFI will be compared with high-definition white light endoscopy (WLE), using histopathology as the reference standard and established endoscopic classifications (Paris, Kudo, and JNET).
The study will also assess adenoma detection rate, serrated lesion detection, inter- and intraobserver agreement, and procedure-related metrics.
調査の概要
状態
まだ募集していません
詳細な説明
This prospective randomized controlled study will compare high-definition white light endoscopy (WLE), Versatile Intelligent Staining Technology (VIST), and Spectral Flexible Imaging (SFI) for the detection and optical characterization of colorectal lesions during colonoscopy.
Participants will be randomized in a 1:1:1 ratio to one of the three imaging modalities. During the first-look withdrawal phase, the colon will be examined using the allocated modality. Detected lesions will be documented and characterized in vivo according to their location, size, morphology, and established endoscopic classification systems, including the Paris, Kudo, and JNET classifications. Lesions will subsequently be biopsied or resected as clinically appropriate and submitted for histopathological evaluation, which will serve as the reference standard for diagnostic performance analyses.
Standardized recordings of colorectal lesions will also be used for blinded review to assess interobserver and intraobserver agreement in optical diagnosis and endoscopic classification. In addition to evaluating lesion detection and characterization, the study will compare procedural quality metrics and safety across the imaging modalities.
The study is designed to determine whether VIST or SFI can improve colorectal lesion detection and optical characterization compared with conventional high-definition white light endoscopy.
研究の種類
介入
入学 (推定)
990
段階
- 適用できない
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。
研究連絡先
- 名前：Ari Ben Hur Stefani Leão, MD
- 電話番号：+55 51 3195 2843
- メール：gpeg.pucrs@gmail.com
研究場所
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Rio Grande do Sul
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Porto Alegre、Rio Grande do Sul、ブラジル、90160-090
- Hospital Sao Lucas da PUCRS
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コンタクト：
- Ari Ben Hur Stefani Leão, MD
- 電話番号：+55 51 3195 2843
- メール：gpeg.pucrs@gmail.com
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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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age ≥ 18 years
- Undergoing screening or surveillance colonoscopy
- Adequate bowel preparation (Boston Bowel Preparation Scale ≥6, with ≥2 per segment)
- Ability to understand and sign informed consent
Exclusion Criteria:
- History of inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- Prior colorectal resection
- Colorectal stenosis preventing scope progression
- Pregnancy or breastfeeding
- Inadequate bowel preparation
- Clinical contraindication to colonoscopy
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
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：White Light Endoscopy (WLE)
Participants randomized to this arm will undergo colonoscopy using high-definition white light endoscopy (WLE) during the first-look withdrawal phase.
Colorectal lesions detected during this phase will be documented and optically characterized according to the study protocol.
Detected lesions will be biopsied or resected as clinically appropriate and submitted for histopathological evaluation.
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Colonoscopy performed using high-definition white light imaging.
他の名前：
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実験的：Versatile Intelligent Staining Technology (VIST)
Participants randomized to this arm will undergo colonoscopy using Versatile Intelligent Staining Technology (VIST) during the first-look withdrawal phase.
Colorectal lesions detected during this phase will be documented and optically characterized according to the study protocol.
Detected lesions will be biopsied or resected as clinically appropriate and submitted for histopathological evaluation.
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Colonoscopy performed using Versatile Intelligent Staining Technology (VIST).
他の名前：
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実験的：Spectral Flexible Imaging (SFI)
Participants randomized to this arm will undergo colonoscopy using Spectral Flexible Imaging (SFI) during the first-look withdrawal phase.
Colorectal lesions detected during this phase will be documented and optically characterized according to the study protocol.
Detected lesions will be biopsied or resected as clinically appropriate and submitted for histopathological evaluation.
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Colonoscopy performed using Spectral Flexible Imaging (SFI).
他の名前：
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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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Adenoma Detection Rate (ADR)
時間枠：During index colonoscopy.
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Proportion of participants with ≥1 colorectal polyp detected during the first-look withdrawal phase using the allocated imaging modality.
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During index colonoscopy.
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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 |
|---|---|---|
|
Serrated Lesion Detection Rate
時間枠：During index colonoscopy.
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Proportion of participants with ≥1 serrated lesion (e.g., sessile serrated lesion or hyperplastic polyp) detected during the first-look withdrawal phase using the allocated imaging modality, with histopathology confirmation when available.
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During index colonoscopy.
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Diagnostic Accuracy for Optical Characterization (Neoplastic vs Non-neoplastic)
時間枠：During index colonoscopy with post-procedure histopathology results.
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Sensitivity, specificity, PPV, NPV, and overall accuracy of optical diagnosis for neoplastic versus non-neoplastic colorectal lesions, using histopathology as the reference standard.
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During index colonoscopy with post-procedure histopathology results.
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Agreement Between Optical Diagnosis and Histopathology
時間枠：During index colonoscopy with post-procedure histopathology results.
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Agreement (Cohen's kappa) between in vivo optical diagnosis and histopathology for colorectal lesions.
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During index colonoscopy with post-procedure histopathology results.
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Concordance of Endoscopic Classifications With Histopathology
時間枠：During index colonoscopy with post-procedure histopathology results.
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Agreement (Cohen's kappa) between endoscopic classifications (Paris, Kudo pit pattern, and JNET) assigned in vivo and histopathology.
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During index colonoscopy with post-procedure histopathology results.
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Interobserver and Intraobserver Agreement From Blinded Video Review
時間枠：Up to 12 months after index colonoscopy (video-based assessment).
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Interobserver and intraobserver agreement (Cohen's kappa) for optical diagnosis and classification based on standardized video recordings of lesions reviewed independently and blinded to group allocation and histopathology.
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Up to 12 months after index colonoscopy (video-based assessment).
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Procedure Quality Metrics
時間枠：During index colonoscopy.
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Withdrawal time (minutes), total procedure time (minutes), and cecal intubation rate.
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During index colonoscopy.
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Safety (Procedure-related Adverse Events)
時間枠：Up to 24 hours after colonoscopy.
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Incidence of colonoscopy-related adverse events (e.g., bleeding, perforation, post-polypectomy complications).
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Up to 24 hours after colonoscopy.
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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。
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 (推定)
2026年10月1日
一次修了 (推定)
2027年1月31日
研究の完了 (推定)
2028年8月31日
試験登録日
最初に提出
2026年8月26日
QC基準を満たした最初の提出物
2026年8月26日
最初の投稿 (実際)
2026年9月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月1日
QC基準を満たした最後の更新が送信されました
2026年8月26日
最終確認日
2026年8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
- 00410826.8.0000.5336
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
IPD プランの説明
The individual participant data (IPD) sharing plan has not yet been determined.
Any future sharing of de-identified participant data will be subject to applicable ethical and institutional requirements, participant confidentiality protections, and relevant data protection regulations.
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