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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 990
- 试验地点
- 1
- 主要终点
- Adenoma Detection Rate (ADR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: White Light Endoscopy (Device)
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.
干预措施: Versatile Intelligent Staining Technology (Device)
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.
干预措施: Spectral Flexible Imaging (Device)
结局指标
主要结局
Adenoma Detection Rate (ADR)
时间窗: During index colonoscopy.
Proportion of participants with ≥1 colorectal polyp detected during the first-look withdrawal phase using the allocated imaging modality.
次要结局
- Serrated Lesion Detection Rate(During index colonoscopy.)
- Diagnostic Accuracy for Optical Characterization (Neoplastic vs Non-neoplastic)(During index colonoscopy with post-procedure histopathology results.)
- Agreement Between Optical Diagnosis and Histopathology(During index colonoscopy with post-procedure histopathology results.)
- Concordance of Endoscopic Classifications With Histopathology(During index colonoscopy with post-procedure histopathology results.)
- Interobserver and Intraobserver Agreement From Blinded Video Review(Up to 12 months after index colonoscopy (video-based assessment).)
- Procedure Quality Metrics(During index colonoscopy.)
- Safety (Procedure-related Adverse Events)(Up to 24 hours after colonoscopy.)
研究者
Alexandre Vontobel Padoin
Professor
Pontificia Universidade Católica do Rio Grande do Sul