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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Adenoma; Colorectal Adenomatous Polyp

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Hungary
  • Nyiri Street 38
    • Kecskemét, Nyiri Street 38, Hungary, 6000
      • Bács Kiskun County and Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All adult patients who did not meet the exclusion criteria were included in the study

Description

Inclusion Criteria:

• The patient must sign, understand and provide written consent for the procedure.
• Undergoing colonoscopy at our endoscopy unit for any indication in Propofol deep sedation
• Intact colon and rectum
• ASA (American Society of Anesthesiology) risk class 1, 2 or 3

Exclusion Criteria:

• Patients with inflammatory bowel disease;
• Patients with poor bowel preparation; (Boston score <4)
• Female patients with pregnancy;
• Patients with mechanical bowel obstruction;
• Patients with diverticulitis or toxic megacolon;
• Patients with a history of radiation therapy to abdomen or pelvis;
• Patients with a history of severe cardiovascular, pulmonary, liver or renal disease and high ASA (>3) risk of propofol sedation;
• Personal history of coagulation disorders or use of anticoagulants;
• Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
LCI out group; The whitdrawal of the colonoscop happen in LCI mode.
WL (white light) out group; The whitdrawal of the colonoscop happen in WL mode.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic value of the computer algorithm	diagnostic value of the computer algorithm (sensitivity, specificity, negative predictive value, positive predictive value, accuracy) [ Time Frame: 10 months ] [ Designated as safety issue: No ]	2 years
Number of detected serrated polyps	Number of Detected Proximal Serrated lesions, flat polyps and colorectal adenomas in proximal colon	2 years
Number of detected polyps	Quantity of total number of colorectal adenomas found in the colon during colonoscopy was recorded and compared.	2 years
the accuracy of the NICE (NBI International Colorectal Endoscopic) criteria using FICE versus BLI Eluxeo technology	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.	2 years
Inter-observer agreement among the 5 experts	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.	2 years
Cecal intubation rate	The proportion of colonoscopy procedures resulting in successful intubation of the cecum.	2 years
Propofol need for deep sedation	The main efficacy parameter is the amount of Propofol used for deep sedation during colonoscopy, expressed as the mean for each group.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic interobserver variability based on the computer algorithm	diagnostic interobserver variability based on the computer algorithm	2 years
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	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.	2 years
Comparison of accuracy of BLI and LCI pictures	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	2 years
Improvement of adenoma detection rate by using LCI imaging comparing with that under white endoscopy	Improvement of adenoma detection rate by using LCI imaging comparing with that under white endoscopy	2 years
Time-to-cecum	Time from initial insertion of colonoscope until successful intubation of the cecum (min)	2 years
Ancillary maneuvers to facilitate procedure	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.	2 years

Collaborators and Investigators

• Sponsor: Bács-Kiskun County Teaching Hospital
• Collaborators: Endo-Kapszula Privat Medical Center
• Investigators: Principal Investigator: Laszlo Madacsy, MD,pHd, Bács Kiskun Coeunty Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (Actual): July 31, 2017

Study Record Updates

• Last Update Posted (Actual): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Adenoma detection rate; Deep learning; Blue light imaging; Linked color imaging; Optical histology; Variable stiffness
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma; Adenomatous Polyps
• Other Study ID Numbers: Deep001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No