Last updated 9 days ago

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

990 patients around the world
Available in Brazil
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.
Alexandre Vontobel Padoin
1Research sites
990Patients around the world

This study is for people with

Colorectal cancer

Requirements for the patient

From 18 Years
All Gender

Medical requirements

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.
Inadequate bowel preparation.
Clinical contraindication to colonoscopy.

Sites

Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Av. Ipiranga, 6690 - 4º andar - Partenon, Porto Alegre - RS, 90610-001, Brazil
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