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Trial record 1 of 1 for:    NCT03234725
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Analysis of New Endoscopic Features and Variable Stiffness in Colonoscopy: Prospective Randomised Trial (ELUFIBLI)

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ClinicalTrials.gov Identifier: NCT03234725
Recruitment Status : Completed
First Posted : July 31, 2017
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
Endo-Kapszula Privat Medical Center
Information provided by (Responsible Party):
László Madácsy Md, PhD, Bács-Kiskun County Teaching Hospital

Brief Summary:

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.


Condition or disease
Colorectal Adenoma Colorectal Adenomatous Polyp

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Randomised Trial to Analyse the Advantages of the New Virtual Chromoendoscopy Features and the Variable Stiffness in Connection With Our Colonoscopic Examinations
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

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.



Primary Outcome Measures :
  1. diagnostic value of the computer algorithm [ Time Frame: 2 years ]
    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. Number of detected serrated polyps [ Time Frame: 2 years ]
    Number of Detected Proximal Serrated lesions, flat polyps and colorectal adenomas in proximal colon

  3. Number of detected polyps [ Time Frame: 2 years ]
    Quantity of total number of colorectal adenomas found in the colon during colonoscopy was recorded and compared.

  4. the accuracy of the NICE (NBI International Colorectal Endoscopic) criteria using FICE versus BLI Eluxeo technology [ Time Frame: 2 years ]
    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.

  5. Inter-observer agreement among the 5 experts [ Time Frame: 2 years ]
    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.

  6. Cecal intubation rate [ Time Frame: 2 years ]
    The proportion of colonoscopy procedures resulting in successful intubation of the cecum.

  7. Propofol need for deep sedation [ Time Frame: 2 years ]
    The main efficacy parameter is the amount of Propofol used for deep sedation during colonoscopy, expressed as the mean for each group.


Secondary Outcome Measures :
  1. diagnostic interobserver variability based on the computer algorithm [ Time Frame: 2 years ]
    diagnostic interobserver variability based on the computer algorithm

  2. 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 [ Time Frame: 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 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.

  3. Comparison of accuracy of BLI and LCI pictures [ Time Frame: 2 years ]
    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

  4. Improvement of adenoma detection rate by using LCI imaging comparing with that under white endoscopy [ Time Frame: 2 years ]
    Improvement of adenoma detection rate by using LCI imaging comparing with that under white endoscopy

  5. Time-to-cecum [ Time Frame: 2 years ]
    Time from initial insertion of colonoscope until successful intubation of the cecum (min)

  6. Ancillary maneuvers to facilitate procedure [ Time Frame: 2 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All adult patients who did not meet the exclusion criteria were included in the study
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234725


Locations
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Hungary
Bács Kiskun County and Teaching Hospital
Kecskemét, Nyiri Street 38, Hungary, 6000
Sponsors and Collaborators
Bács-Kiskun County Teaching Hospital
Endo-Kapszula Privat Medical Center
Investigators
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Principal Investigator: Laszlo Madacsy, MD,pHd Bács Kiskun Coeunty Teaching Hospital

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Responsible Party: László Madácsy Md, PhD, Clinical Professor, Bács-Kiskun County Teaching Hospital
ClinicalTrials.gov Identifier: NCT03234725     History of Changes
Other Study ID Numbers: Deep001
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by László Madácsy Md, PhD, Bács-Kiskun County Teaching Hospital:
Blue light imaging
Linked color imaging
Optical histology
Adenoma detection rate
Variable stiffness
Deep learning

Additional relevant MeSH terms:
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Adenoma
Adenomatous Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms