Neoplasms

All Conditions

Symptoms and General Pathology

Adenoma

Polyps

Adenomatous Polyps

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Imidacloprid

The whitdrawal of the colonoscop happen in LCI mode.

The whitdrawal of the colonoscop happen in WL mode.

Laszlo Madacsy, MD,pHd

The aim of the present study is to develop and evaluate a computer-based methods for automated and improved detection and classification of different colorectal lesions, especially polyps. For this purpose first, pit pattern and vascularization features of up to 1000 polyps with a size of 10 mm or smaller will be detected and stored in our web based picture database made by a zoom BLI colonoscopy. These polyps are going to be imaged and subsequently removed for histological analysis. The polyp images are analyzed by a newly developed deep learning computer algorithm. The results of the deep learning automatic classification (sensitivity, specificity, negative predictive value, positive predictive value and accuracy) are compared to those of human observers, who were blinded to the histological gold standard.

In a second approach we are planning to use LCI of the colon, rather than the usual white light. Here, we will determine, whether this technique could improve the detection of flat neoplastic lesions, laterally spreading tumors, small pedunculated adenomas and serrated polyps. The polyps are called serrated because of their appearance under the microscope after they have been removed. They tend to be located up high in the colon, far away from the rectum. They have been definitely shown to be a type of precancerous polyp and it is possible that using LCI will make it easier to see them, as they can be quite difficult to see with standard white light.

Computer-based Classification and Differentiation of Colorectal Polyps Using Blue Light Imaging (BLI)

Purpose

Recent studies have shown that optical chromoendoscopy with narrow-band imaging (NBI) of Fuji Intelligent Color Enhancement (FICE) is a powerful diagnostic tool for the differentiation between neoplastic and non-neoplastic colorectal polyps. Linked color imaging (LCI) and blue laser imaging (BLI) are two new imaging systems used in endoscopy which are recently developed. BLI was developed to compensate for the limitations of NBI. BLI shows a bright image of the digestive mucosa, enabling the detailed visualization of both the microstructure and microvasculature. The ELUXEO™ endoscopic system powered by Fujifilm's unique 4-LED (light-emitting diode) Multi Light™ technology sets a new standard in light intensity and electronic chromoendoscopy imaging. By combining four different wavelengths and the specific application of intensified from light spectra created by the integrated light source, this technology allows to easily switch between the three imaging modes White Light, Blue Light Imaging (BLI) and Linked Colour Imaging (LCI). Blue light imaging (BLI) is a new system for image-enhanced electronic chromoendoscopy, since the 410 nm LED visualizes vascular microarchitecture, similar to narrow band imaging, and a 450 nm provides white light by excitation. According to three recently published reports, the diagnostic ability of polyp characterization using blue light imaging compares favorably with narrow band imaging. No published data are available to date regarding computer assisted polyp characterization with blue light imaging.

The aim of the present study is to develop and evaluate a computer-based method for automated classification of small colorectal polyps on the basis of pit pattern and vascularization features. In this prospective study up to 1000 polyps with a size of 10 mm or smaller should be detected and stored in our web based picture database made by a zoom BLI colonoscopy. These polyps were imaged and subsequently removed for histological analysis. The polyp images were analyzed by a newly developed deep learning computer algorithm. The proposed computer-based method consists of several steps: picture annotation, preprocessing, vessel segmentation, feature extraction and classification, parameterization, and finally train and test of the multiple neural layer algorithms. The results of the deep learning automatic classification (sensitivity, specificity, negative predictive value, positive predictive value and accuracy) were compared to those of human observers, who were blinded to the histological gold standard.

Condition Colorectal Polyps with a size less then 10 mm

Study Type:

Observational

Study Design:

Observational Model: Cohort Time Perspective: Prospective

Official Title:

Computer-based Classification and Differentiation of Colorectal Polyps Using Fujifilm Blue Light Imaging (BLI)

Linked color imaging (LCI) and magnifying blue laser imaging (BLI) are two new imaging systems used in endoscopy which are recently developed. The newly developed LCI system (FUJIFILM Co.) creates clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light on the basis of BLI technology. LCI makes red areas appear redder and white areas appear whiter. Thus, it is easier to recognize a slight difference in color of the mucosa. The aim the present study to determine if using LCI of the colon, rather than the usual white light on the colon, will improve the detection of flat neoplastic lesions, laterally spreading tumors, small pedunculated adenomas and serrated polyps. The polyps are called serrated because of their appearance under the microscope after they have been removed. They tend to be located up high in the colon, far away from the rectum. They have been definitely shown to be a type of precancerous polyp and it is possible that using LCI will make it easier to see them, as they can be quite difficult to see with standard white light.

Analysis of New Endoscopic Features and Variable Stiffness in Colonoscopy: Prospective Randomised Trial

Prospective Randomised Trial to Analyse the Advantages of the New Virtual Chromoendoscopy Features and the Variable Stiffness in Connection With Our Colonoscopic Examinations

diagnostic value of the computer algorithm (sensitivity, specificity, negative predictive value, positive predictive value, accuracy) \[ Time Frame: 10 months \] \[ Designated as safety issue: No \]

Number of Detected Proximal Serrated lesions, flat polyps and colorectal adenomas in proximal colon

Quantity of total number of colorectal adenomas found in the colon during colonoscopy was recorded and compared.

the accuracy of the NICE criteria using FICE versus BLI Eluxeo technology without optical zoom for differentiating between the non-neoplastic and neoplastic histotypes in diagnoses with high-confidence on a video-library of 120 polyps reviewed by 5 experts. 5 experts will review pictures from a web-library of subcentimetric polyps removed and histologically verified and will assess each of the three NICE criteria (colour/vascularization/surface), and classify the lesion as neoplastic or non-neoplastic with low or high confidence.

Inter-observer agreement among the 5 experts \[ Time Frame: up to 6 months \] \[ Designated as safety issue: No \] The inter-observer agreement, among the 5 experts, on the final diagnosis (neoplastic or non-neoplastic) and on each individual NICE criterion for each polyp will be determined by using K statistics.

The proportion of colonoscopy procedures resulting in successful intubation of the cecum.

The main efficacy parameter is the amount of Propofol used for deep sedation during colonoscopy, expressed as the mean for each group.

diagnostic interobserver variability based on the computer algorithm

the accuracy of the NICE criteria using FICE versus BLI Eluxeo technology with 50x optical zoom for differentiating between the non-neoplastic and neoplastic histotypes in diagnoses with high-confidence on a video-library of 120 polyps reviewed by 5 experts (ML, SZM, OL, SZA, DZS)5 experts will review pictures from a web-library of subcentimetric polyps removed and histologically verified and will assess each of the three NICE criteria (colour/vascularization/surface), and classify the lesion as neoplastic or non-neoplastic with low or high confidence.

Comparison of accuracy of BLI and LCI pictures with and without zoom on the final diagnosis (neoplastic or non-neoplastic polyp) as compared to histology

Improvement of adenoma detection rate by using LCI imaging comparing with that under white endoscopy

Time from initial insertion of colonoscope until successful intubation of the cecum (min)

A number of added maneuvers, including abdominal pressure, repositioning of the patient, endoscope loop reduction techniques, used to facilitate advancement of the endoscope during the procedure.

Endo-Kapszula Privat Medical Center

Bács-Kiskun County Teaching Hospital

Clinical Professor

Digestive System Diseases

Rare Diseases

Stomach Neoplasms

Barrett Esophagus

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Precancerous Conditions

Esophageal Diseases

Stomach Cancer

Participant undergoes gastroscopy via Linked Color Imaging first, then followed by White Light Imaging

Participant undergoes gastroscopy via White Light Imaging first, then followed by Linked Color Imaging

Linked Color Imaging (LCI) is a form of image enhanced endoscopy that uses a laser endoscopic system that acquires images by simultaneously using narrow-band wavelength light and white light in an appropriate balance. This enhances slight color differences in the red region of the mucosa.

Linked Color Imaging

White Light Imaging (WLI) uses conventional white light that encompasses all bandwidths of light to illuminate areas of interest to obtain endoscopic images.

White Light Imaging

Tiing Leong Ang, MBBS

This study aims to examine the use of Linked Color Imaging in detection of gastric cancer precursors, as well as oesophageal and duodenal lesions.

Gastric cancer is the fifth most common cause of death worldwide. Early detection and removal of gastric cancer precursors and early gastric cancer is crucial for good outcomes. However, these lesions are subtle and often missed by conventional white light imaging (WLI) endoscopy. Image enhanced endoscopy techniques have been developed to enhance the detection and characterization of gastrointestinal lesions. Narrow band imaging (NBI) is one such technique. Though widely used, its drawbacks include a limited far view as a result of the optical filter causing a dark endoscopic view. Linked color imaging (LCI) is a more recent image enhanced endoscopy technique that acquires images by using both narrow-band wavelength light and white light in an appropriate balance, enhancing slight color differences in the red region of mucosa. It has been proven to improve detection of H pylori gastritis and colorectal neoplasms. Thus far, there has been no study to determine whether the use of LCI will increase the detection rate of gastric cancer precursors and early gastric cancer compared to WLI. This study aims to determine whether LCI can increase the detection rate of gastric cancer precursors and early gastric cancer when compared to white light endoscopy, with the null hypothesis being no difference in detection rates. This study will also examine the use of LCI with magnification to predict histology findings for focal lesions seen on endoscopy, as well as the use of LCI in identifying esophageal lesions (such as Barett's esophagus) and duodenal lesions.

Linked Color Imaging vs White Light Imaging for Detection of Gastric Cancer Precursors

A Prospective Randomized Study of Linked Color Imaging and Conventional White Light Imaging in Gastroscopy for the Detection of Gastric Cancer Precursors

Includes Intestinal Metaplasia, Gastric Adenoma, Low Grade Dysplasia, High Grade Dysplasia, Early Gastric Cancer

Includes Barrett's Oesophagus, Low Grade Dysplasia, High Grade Dysplasia, Early Oesophageal Cancer

Includes Duodenal adenoma, Duodenal adenocarcinoma

Singapore General Hospital

Changi General Hospital

Colonic Polyps

Intestinal Polyps

Pathological Conditions, Anatomical

Herbal and Botanical

Cola

Use of narrow band imaging with LCI for colon inspection during both insertion and withdrawal phase of colonoscopy

Franco Radaelli, MD

Linked color imaging (LCI) is newly developed image-enhancing endoscopy technology that differentiates the red color spectrum more effectively than white light imaging thanks to its optimal pre-process composition of light spectrum and advanced signal processing. This technology, combined in the latest generation Fujifilm's endoscopes (Fujifilm Co, Tokyo, Japan) with new high-performance LED illumination system, enhances the visibility of colonic mucosal vessels and might increase the detection rate of colorectal polyps. Data available regarding colorectal polyp or adenoma detection with LCI are encouraging but are scanty and limited to back-to back studies.

This two parallel arms, randomized, multicenter trial is aimed at evaluating whether LCI is superior to WL endoscopy in terms of adenoma detection

50-75 years-old subjects participating in the regional screening program undergoing their first colonoscopy following a positive immunochemical fecal occult blood test (FIT) and meeting all eligibility criteria are randomised 1:1 to LCI (LCI group) or WLI (WL) during insertion and withdrawal phase of colonoscopy. A randomisation list for each participating center was produced by the coordinating center via computer-generated treatment code list. Randomisation is stratified by gender, age (50-60, 61-729 years) and screening history (first vs subsequent test) through an online centralised study database.All procedures are performed with a high-definition ELUXEO 700 series videocolonscopes with or without magnification (EC-760R, EC-760ZP, FUJIFILM Co., Tokyo).

The primary outcome measure is the ADR, defined as the proportion of participants with at least one adenoma (per-patient analysis).

Linked Color Imaging (LCI) for Colorectal Adenoma Detection

Linked Color Imaging (LCI) Versus Standard White-light Colonoscopy for Colorectal Adenoma Detection: a Multicenter, Randomized, Trial

proportion of participants with at least one adenoma (per-patient analysis)

proportion of participants with at least one advanced adenoma

total number of detected lesions in each group divided by the total number of participants

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Analysis of New Endoscopic Features and Variable Stiffness in Colonoscopy: Prospective Randomised Trial	NCT03234725	Colorectal Aden... Colorectal Aden...		18 Years - 99 Years	Bács-Kiskun County Teaching Hospital
Analysis of New Endoscopic Features and Variable Stiffness in Colonoscopy: Prospective Randomised Trial	NCT03234725	Colorectal Aden... Colorectal Aden...		18 Years - 99 Years	Bács-Kiskun County Teaching Hospital
Linked Color Imaging vs White Light Imaging for Detection of Gastric Cancer Precursors	NCT03990025	Early Gastric C... Barrett Esophag...	Linked Color Im... White Light Ima...	50 Years - 100 Years	Changi General Hospital
Analysis of New Endoscopic Features and Variable Stiffness in Colonoscopy: Prospective Randomised Trial	NCT03234725	Colorectal Aden... Colorectal Aden...		18 Years - 99 Years	Bács-Kiskun County Teaching Hospital
Linked Color Imaging vs White Light Imaging for Detection of Gastric Cancer Precursors	NCT03990025	Early Gastric C... Barrett Esophag...	Linked Color Im... White Light Ima...	50 Years - 100 Years	Changi General Hospital
Linked Color Imaging (LCI) for Colorectal Adenoma Detection	NCT03690297	Colon Adenoma Colonic Polyp	Linked Color Im...	50 Years - 72 Years	Valduce Hospital

Spots Global Cancer Trial Database for linked color imaging