UMIN-CTR Clinical Trial

Public title

Prospective study on clinical practice using ultra magnifying endoscope and artificial intelligence -regarding diagnostic accuracy and image acquisition rate of colorectal tumor and cancer-

Acronym

Prospective study on clinical practice using ultra magnifying endoscope and artificial intelligence

Scientific Title

Prospective study on clinical practice using ultra magnifying endoscope and artificial intelligence -regarding diagnostic accuracy and image acquisition rate of colorectal tumor and cancer-

Scientific Title:Acronym

Prospective study on clinical practice using ultra magnifying endoscope and artificial intelligence

Region

Japan

Condition

colorectal tumor and cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

In addition to verifying the diagnostic accuracy of tumor and cancer in computer-aided diagnosis (CAD) system for endocytoscopy (EC)(EC-CAD), we conducted a magnifying and ultra magnifying observation using narrow band- imaging system to evaluate an appropriate image acquisition rate.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

This trial will be triple primary endpoint clinical trial.

1.When EC-CAD was used under methylene blue staining for polyps of 5 mm or less in
diameter in the sigmoid colon from the rectum, it was verified that the result diagnosed with high confidence (probability 90% or more) was NPV 90% or more.

2.When observing a polyp of 5 mm or less in diameter with magnifying narrow band imaging (NBI) and NBI combined endocytoscopy (EC-NBI), verify that the ratio at which trainee can acquire a focused endoscope video for 3 seconds or more at EC-NBI.

3.When EC-CAD is used under methylene blue staining for colon lesions of 20 mm or more in diameter, we verify that the diagnostic ability for invasive cancer is over 90% PPV.

Key secondary outcomes

1.Diagnostic accuracy of diminitive polyps in EC-CAD and diagnostic accuracy at high confidence in sigmoid colon and rectum.
2.Diagnostic accuracy of diminitive polyps in EC-NBI-CAD and diagnostic accuracy at high confidence in sigmoid colon or rectum.
3.Percentage of methylene blue staining or EC-CAD-NBI succesfuly performed for diminitive polyps less than 5 mm.
4.Diagnostic performance of EC-CAD for polyps whose diameters are 6-9mm or 10mm-
5.Discussion on differences between experts and trainees in each secondary outcome from 1 to 3.
6.Percentage of cases experts can acquire images that were in focus using EC-NBI and NBI for more than 3 seconds.
7.Percentage of cases where experts and trainees can acquire one or more EC-NBI and magnifying NBI images.
8.Percentage of cases where experts and trainees can obtain an in-focus image for 3 seconds or more with diminitive polyps of 5 mm or less and other polyps.
9.Percentage by localization of lesions when experts and trainees can acquire an in-focus image for more than 3 seconds.
10.The difference of the longest time that it was possible to maintain the focused state with EC-NBI and magnifying NBI image.
11.Sensitivity, specificity, correct diagnostic rate, PPV, NPV for invasive cancer when expert and trainee use EC - CAD for colon neoplastic lesions of 20 mm or more.
12.Examination of the cause of EC-CAD diagnostic results becoming low confidence or not a good sample when experts and trainees use EC-CAD.
13.Comparison of the difference in time taken by experts and trainees to acquire 10 EC images after acquiring first EC image.
14.Verification of the influence of depth of tumor on diagnostic results using EC-CAD.
15.Comparison of the difference depending on the depth of tumor invasion when evaluating vessel diameter and caliber change
using CAD for EC-NBI.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Case of over 18 years old at the time of endoscopic examination
2.Case in which pathological diagnosis is possible by biopsy, endoscopic or surgical resection for colon lesions.
3.Cases with normal judgment ability and can express intention

Key exclusion criteria

1.In cases where histological evaluation is impossible (biopsy, pathological evaluation of excised specimens not yet performed).
2.Cases in which pretreatment such as anticancer drug therapy, radiotherapy etc is done.
3.The patient made an offer to refuse to use data with opt-out.
4.A case with inflammatory bowel disease.
5.In addition, cases in which clinical researcher or clinical research sharing doctor judged inappropriate as subject of this examination. .

Target sample size

600

Name of lead principal investigator

1st name
Middle name
Last name	Yuichi Mori

Organization

Showa University Northern Yokohama Hospital

Division name

Digestive Disease Center

Zip code

Address

35-1 Chigasaki-chuo, Tsudukiku, Yokohama City, Kanagawa

TEL

045-949-7000

Email

ibusiginjp@gmail.com

Name of contact person

1st name
Middle name
Last name	Kenichi Takeda

Organization

Showa University Northern Yokohama Hospital

Division name

Digestive Disease Center

Zip code

Address

35-1 Chigasaki-chuo, Tsudukiku, Yokohama City, Kanagawa

TEL

045-949-7000

Homepage URL

Email

ktluck1208@yahoo.co.jp

Institute

Showa University Northern Yokohama Hospital

Institute

Department

Personal name

Organization

JAPAN SOCIETY FOR THE PROMOTION OF SCIENCE

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2017

Year

05

Month

02

Day

Date of IRB

Anticipated trial start date

2017

Year

06

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

open public recruiting

Registered date

2017

Year

05

Month

16

Day

Last modified on

2017

Year

12

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031349