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NBI system can improve the patterns of mucosal surface and vascularity of colonic polyp.

Observation using NBI system

I-Scan system can improve the patterns of mucosal surface and vascularity of colonic polyp.

Observation using i-Scan system

Chang Kyun Lee, MD, PhD

Several novel imaging technologies are currently used for detection and differentiation of colonic polyps during colonoscopy, such as NBI (Olympus), FICE (Fujinon), and i-Scan (Pentax).

Several previous studies have indicated that NBI without magnification can be useful for real-time differentiation of diminutive colonic neoplasias.

To date, however, there are no studies comparing NBI with other imaging systems (FICE or i-Scan) for differentiation of diminutive colonic polyps.

The study objectives are to compare the diagnostic efficacy of NBI with that of i-Scan in real-time prediction of diminutive colonic polyps.

In this prospective pilot study, diminutive colonic polyps detected during colonoscopy will be observed with conventional colonoscopy, thereafter will be observed with new imaging systems.

Sensitivity, specificity, and diagnostic accuracy of both NBI and i-Scan will be assessed by reference to histological results obtained by endoscopic biopsy or polypectomy.

Comparative Study of Postprocessing Imaging Systems for Diminutive Colonic Polyps

Prospective Comparison of NBI and i-Scan in Real-time Histological Prediction of Diminutive Colonic Polyps

Sensitivity, specificity, and diagnostic accuracy

Soon Chun Hyang University

MD, PhD

Digestive System Diseases

Carcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Patients from the control group will be examined using a CF-HQ 190 EVIS Exera III Advanced Diagnostic Video Colonoscope. If colon polyps are detected optical diagnosis will be determined WITHOUT using the NBI function of the scope.

Patients from the control group will be examined using a CF-HQ 190 EVIS Exera III Advanced Diagnostic Video Colonoscope. If colon polyps are detected optical diagnosis will be determined by using the NBI function of the scope.

In the intervention arm polyps will be optically characterized using the NBI function. The WASP (Workgroup serrAted polypS and Polyposis) classification will be used in order to determine the optical diagnosis.

NBI Function

Peter Klare, MD

Timo Rath, Professor

Jan Peveling-Oberhag, MD

Roland M Schmid, Professor

Adenomas, serrated adenomas and hyperplastic polyps are polypoid lesion in the colorectum. At the present moment, all polyps should be resected endoscopically, although only adenomas and serrated adenomas, but not hyperplastic polyps have the potential to develop colorectal cancer. This approach enables the conduction of microscopic investigations of the lesions. By today, only the pathological diagnosis can distinguish exactly between these three polyp entities. Some studies have investigated the value of the optical characterization approach which is based on visual assessment of the polyp' surface structures. Based upon optical polyp features users are encouraged to predict histopathological polyp diagnoses solely on behalf of optical or endoscopical criteria. This method is conducted in real time during colonoscopy. If it could be shown, that endoscopist using the optical characterization approach are able to predict histopathological diagnoses of colonic polyps sufficiently this would possibly lead to simplification of diagnostic procedures. For instance, it would be conceivable to resect small polyps and discard them without further assessment by a pathologist. One problem in this context is a correct differentiation between hyperplastic polyps and serrated adenomas. These two polyp entities are known to show similar optical features. However, while serrated adenomas are premalignant lesions hyperplastic polyps have benign histology and never develop into cancer. It is therefore important to sufficiently distinguish hyperplastic polyps from serrated lesions.

In this study we want to investigate whether the use of narrow-band imaging (NBI) would be capable to rise accuracy of optical polyp predictions compared to standard HD white light endoscopy. NBI is a light filter tool which can be activated by pressing a button at the endoscope. The use of NBI leads to an endoscopic picture which appears blue and enables endoscopists to better assess surface structures and vascular patterns.

In a prospective randomised multicenter setting we plan to conduct colonoscopy in 370 patients. Half of the patients will be examined without the use of NBI (control arm). In these cases colonoscopists will assess optical diagnosis of polyps without turning on the NBI tool. If polyps are detected in patients belonging to the intervention arm NBI will be used and optical diagnosis will be determined using the WASP (Workgroup serrAted polypS and Polyposis) classification. All polyps will be resected and send to pathology for further microscopic assessment. After completing the trial we aim to compare accuracy of the optical diagnosis in both groups. Our hypothesis is, that by using NBI accordance between optical and histopathological diagnosis can be increased from 80% to 90%.

NBI Versus White Light Endoscopy for Optical Characterization of Neoplastic Polyps in the Colorectum

NBI Versus White Light Endoscopy for Optical Characterization of Neoplastic Polyps in the Colorectum - the ADOPTION II Study

After obtaining the histopathological diagnosis of resected polyps (approximately 3 days - 2 weeks after colonoscopy ) accuracy of optical diagnosis can be determined

Technical University of Munich

Dr. med. Peter Klare

Centers for Disease Control and Prevention (CDC) Study of In-home Tests for Colorectal Cancer (SIT)

New York University (NYU) Human Microbiome and Colorectal Tumor study

16S rRNA amplicons covering variable regions V3 to V4 were generated using primers (347F-5'GGAGGCAGCAGTRRGGAAT'-3' and 803R 5'-CTACCRGGGTATCTAATCC-3') incorporating Roche 454 FLX Titanium adapters (Branford, CT) and a sample barcode sequence

Mobio PowerSoil DNA Isolation Kit

Jiyoung Ahn, MD

Gut microbiota were assessed in 540 colonoscopy-screened adults by 16S rRNA gene sequencing of stool samples. Investigators compared gut microbiota diversity, overall composition, and normalized taxon abundance among these groups.

Colorectal cancer is a heterogeneous disease arising from at least two precursors-the conventional adenoma (CA) and the serrated polyp. A relationship between the human gut microbiota and colorectal cancer has been shown; however, its relationship to the different early precursors of colorectal cancer is understudied. This study tested, for the first time, the relationship of the gut microbiota to specific colorectal polyp types.

DNA was extracted from stool using the PowerLyzer PowerSoil Kit (Mo Bio Laboratory Inc., CA) following the manufacturer's protocol. DNA was collected and eluted using silica columns included with the PowerLyzer PowerSoil kit. Barcoded amplicons were generated covering the V4 region of the 16S rRNA gene using the F515/R806 primer pair.

Study of Gut Microbiome and Colorectal Tumors

The Gut Microbiota in Conventional and Serrated Precursors of Colorectal Cancer

NYU Langone Health

COLONIC POLYP HISTOLOGY PREDICTION IN WHITE LIGHT IMAGES COMBINING ARTIFICIAL INTELLIGENCE AND CLINICAL INFORMATION

AUTOMATED POLYP CLASSIFICATION

Our group, prior to the present study, developed a handcrafted predictive model based on the extraction of surface patterns (textons) with a diagnostic accuracy of over 90%24. This method was validated in a small dataset containing only high-quality images.

Artificial intelligence is expected to improve the accuracy of colorectal polyp optical diagnosis. We propose a hybrid approach combining a Deep learning (DL) system with polyp features indicated by clinicians (HybridAI). A pilot in vivo experiment will carried out.

Optical diagnosis aims to predict the histology of a polyp based on its endoscopic features. This practice could avoid histopathological analysis and reduce the derived costs. Under this premise, the American Society of Gastrointestinal Endoscopy (ASGE), in its Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) statement, established a diagnostic threshold for real-time endoscopic assessment of diminutive polyps. The rationale for its implementation is that the prevalence of advanced histology in polyps \< 5mm is very low (0.5%).

Several studies have demonstrated that optical diagnosis of small polyps is safe and feasible in clinical practice and comparable to the current gold standard, histopathology. However, the accuracy of optical diagnosis has been shown to be insufficient in community-based practices or in non-expert hands and the diagnosis is even more difficult in diminutive polyps \< 3 mm in which the discrepancy between the endoscopic and pathological diagnosis is about 15%.

Artificial Intelligence (AI) has emerged as a help tool for polyp characterization.

Aiming to improve optical diagnosis using AI methods, we propose a hybrid approach that combines DL with characteristics of polyps manually indicated by endoscopists (HybridAI).

In Vivo Computer-aided Prediction of Polyp Histology on White Light Colonoscopy

The results of the computer-aided system prediction will be compared with the final pathology report, which is the gold standard

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparative Study of Postprocessing Imaging Systems for Diminutive Colonic Polyps	NCT01133041	Diminutive Colo... Adenomatous Pol... Hyperplastic Po... Colonoscopy	Observation usi... Observation usi...	18 Years -	Soon Chun Hyang University
NBI Versus White Light Endoscopy for Optical Characterization of Neoplastic Polyps in the Colorectum	NCT03679429	Colon Adenoma Colorectal Carc... Hyperplastic Po... Serrated Adenom...	NBI Function	40 Years - 90 Years	Technical University of Munich
NBI Versus White Light Endoscopy for Optical Characterization of Neoplastic Polyps in the Colorectum	NCT03679429	Colon Adenoma Colorectal Carc... Hyperplastic Po... Serrated Adenom...	NBI Function	40 Years - 90 Years	Technical University of Munich
Study of Gut Microbiome and Colorectal Tumors	NCT03297996	Serrated Polyp Hyperplastic Po... Sessile Serrate... Colorectal Canc...	Mobio PowerSoil...	18 Years -	NYU Langone Health
Comparative Study of Postprocessing Imaging Systems for Diminutive Colonic Polyps	NCT01133041	Diminutive Colo... Adenomatous Pol... Hyperplastic Po... Colonoscopy	Observation usi... Observation usi...	18 Years -	Soon Chun Hyang University
In Vivo Computer-aided Prediction of Polyp Histology on White Light Colonoscopy	NCT03775811	Colonoscopy Histology Computer-aided ... Artificial Inte... Colorectal Poly... Adenoma Colon P... Hyperplastic Po...	AUTOMATED POLYP...	18 Years -	Hospital Clinic of Barcelona
Study of Gut Microbiome and Colorectal Tumors	NCT03297996	Serrated Polyp Hyperplastic Po... Sessile Serrate... Colorectal Canc...	Mobio PowerSoil...	18 Years -	NYU Langone Health
NBI Versus White Light Endoscopy for Optical Characterization of Neoplastic Polyps in the Colorectum	NCT03679429	Colon Adenoma Colorectal Carc... Hyperplastic Po... Serrated Adenom...	NBI Function	40 Years - 90 Years	Technical University of Munich

Spots Global Cancer Trial Database for hyperplastic polyp