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.
研究概览
地位
尚未招聘
详细说明
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.
研究类型
介入性
注册 (估计的)
990
阶段
- 不适用
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。
学习联系方式
- 姓名：Ari Ben Hur Stefani Leão, MD
- 电话号码：+55 51 3195 2843
- 邮箱：gpeg.pucrs@gmail.com
学习地点
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Rio Grande do Sul
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Porto Alegre、Rio Grande do Sul、巴西、90160-090
- Hospital Sao Lucas da PUCRS
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接触：
- Ari Ben Hur Stefani Leão, MD
- 电话号码：+55 51 3195 2843
- 邮箱：gpeg.pucrs@gmail.com
-
-
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
- 成人
- 年长者
接受健康志愿者
不
描述
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
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
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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.
|
Colonoscopy performed using high-definition white light imaging.
其他名称：
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实验性的：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.
|
Colonoscopy performed using Versatile Intelligent Staining Technology (VIST).
其他名称：
|
|
实验性的：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.
|
Colonoscopy performed using Spectral Flexible Imaging (SFI).
其他名称：
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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 |
|---|---|---|
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Adenoma Detection Rate (ADR)
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Serrated Lesion Detection Rate
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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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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。
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 (估计的)
2026年10月1日
初级完成 (估计的)
2027年1月31日
研究完成 (估计的)
2028年8月31日
研究注册日期
首次提交
2026年8月26日
首先提交符合 QC 标准的
2026年8月26日
首次发布 (实际的)
2026年9月1日
研究记录更新
最后更新发布 (实际的)
2026年9月1日
上次提交的符合 QC 标准的更新
2026年8月26日
最后验证
2026年8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
- 00410826.8.0000.5336
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
IPD 计划说明
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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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.