Colorectal Neoplasms, Colonic Polyps, Adenoma, Serrated Polyps, Colorectal Cancer Screening
Conditions
Keywords
Colonoscopy, Adenoma Detection Rate, Optical Diagnosis, Image-Enhanced Endoscopy, Electronic Chromoendoscopy, Versatile Intelligent Staining Technology (VIST), Spectral Flexible Imaging (SFI), White Light Endoscopy, JNET Classification, Kudo Pit Pattern
Brief summary
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.
Detailed description
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.
Interventions
DEVICEWhite Light Endoscopy
Colonoscopy performed using high-definition white light imaging.
DEVICEVersatile Intelligent Staining Technology
Colonoscopy performed using Versatile Intelligent Staining Technology (VIST).
DEVICESpectral Flexible Imaging
Colonoscopy performed using Spectral Flexible Imaging (SFI).
Sponsors
Alexandre Vontobel Padoin
Hospital Sao Lucas da PUCRS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Participants will be randomized in a 1:1:1 ratio to one of three parallel groups: high-definition white light endoscopy (WLE), Versatile Intelligent Staining Technology (VIST), or Spectral Flexible Imaging (SFI). Each participant will undergo the first-look withdrawal phase using the imaging modality assigned to their study group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma Detection Rate (ADR) | During index colonoscopy. | Proportion of participants with ≥1 colorectal polyp detected during the first-look withdrawal phase using the allocated imaging modality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serrated Lesion Detection Rate | During index colonoscopy. | 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) | During index colonoscopy with post-procedure histopathology results. | 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 | During index colonoscopy with post-procedure histopathology results. | Agreement (Cohen's kappa) between in vivo optical diagnosis and histopathology for colorectal lesions. |
| Concordance of Endoscopic Classifications With Histopathology | During index colonoscopy with post-procedure histopathology results. | Agreement (Cohen's kappa) between endoscopic classifications (Paris, Kudo pit pattern, and JNET) assigned in vivo and histopathology. |
| Interobserver and Intraobserver Agreement From Blinded Video Review | Up to 12 months after index colonoscopy (video-based assessment). | 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. |
| Procedure Quality Metrics | During index colonoscopy. | Withdrawal time (minutes), total procedure time (minutes), and cecal intubation rate. |
| Safety (Procedure-related Adverse Events) | Up to 24 hours after colonoscopy. | Incidence of colonoscopy-related adverse events (e.g., bleeding, perforation, post-polypectomy complications). |
Countries
Brazil
Contacts
CONTACTAri Ben Hur Stefani Leão, MD
Outcome results
None listed