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.
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
History of inflammatory bowel disease (Crohn's disease or ulcerative colitis)
Prior colorectal resection
Colorectal stenosis preventing scope progression
Pregnancy or breastfeeding
Parallel
White Light Endoscopy
DeviceColonoscopy performed using high-definition white light imaging.
Versatile Intelligent Staining Technology
DeviceColonoscopy performed using Versatile Intelligent Staining Technology (VIST).
Spectral Flexible Imaging
DeviceColonoscopy performed using Spectral Flexible Imaging (SFI).
Adenoma Detection Rate (ADR)
Proportion of participants with ≥1 colorectal polyp detected during the first-look withdrawal phase using the allocated imaging modality.
Serrated Lesion Detection Rate
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.
Diagnostic Accuracy for Optical Characterization (Neoplastic vs Non-neoplastic)
Sensitivity, specificity, PPV, NPV, and overall accuracy of optical diagnosis for neoplastic versus non-neoplastic colorectal lesions, using histopathology as the reference standard.
Agreement Between Optical Diagnosis and Histopathology
Agreement (Cohen's kappa) between in vivo optical diagnosis and histopathology for colorectal lesions.
Concordance of Endoscopic Classifications With Histopathology
Agreement (Cohen's kappa) between endoscopic classifications (Paris, Kudo pit pattern, and JNET) assigned in vivo and histopathology.
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Alexandre Vontobel Padoin
Lead sponsor
Pontificia Universidade Católica do Rio Grande do Sul
Sponsor institution
Hospital Sao Lucas da PUCRS
Collaborator
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