Colorectal Adenoma Clinical Trial
— ELUFIBLIOfficial title:
Prospective Randomised Trial to Analyse the Advantages of the New Virtual Chromoendoscopy Features and the Variable Stiffness in Connection With Our Colonoscopic Examinations
NCT number | NCT03234725 |
Other study ID # | Deep001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2016 |
Est. completion date | September 30, 2018 |
Verified date | July 2019 |
Source | Bács-Kiskun County Teaching Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1000 |
Est. completion date | September 30, 2018 |
Est. primary completion date | September 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Hungary | Bács Kiskun County and Teaching Hospital | Kecskemét | Nyiri Street 38 |
Lead Sponsor | Collaborator |
---|---|
Bács-Kiskun County Teaching Hospital | Endo-Kapszula Privat Medical Center |
Hungary,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Number of detected serrated polyps | Number of Detected Proximal Serrated lesions, flat polyps and colorectal adenomas in proximal colon | 2 years | |
Primary | Number of detected polyps | Quantity of total number of colorectal adenomas found in the colon during colonoscopy was recorded and compared. | 2 years | |
Primary | 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 | |
Primary | 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 | |
Primary | Cecal intubation rate | The proportion of colonoscopy procedures resulting in successful intubation of the cecum. | 2 years | |
Primary | 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 | diagnostic interobserver variability based on the computer algorithm | diagnostic interobserver variability based on the computer algorithm | 2 years | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Time-to-cecum | Time from initial insertion of colonoscope until successful intubation of the cecum (min) | 2 years | |
Secondary | 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 |
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