UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035386
Receipt number R000040320
Scientific Title Prospective exploratory study about the laser endoscopy findings of duodenal epithelium in medical examinees
Date of disclosure of the study information 2019/01/11
Last modified on 2024/01/05 19:28:08

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Basic information

Public title

Prospective exploratory study about the laser endoscopy findings of duodenal epithelium in medical examinees

Acronym

LCI-D

Scientific Title

Prospective exploratory study about the laser endoscopy findings of duodenal epithelium in medical examinees

Scientific Title:Acronym

LCI-D

Region

Japan


Condition

Condition

None

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the clinical features about the difference of the duodenal epithelium color by LCI (linked color imaging) about the medical examenees with gastroscopy

Basic objectives2

Others

Basic objectives -Others

None

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The color of duodenal epithelium with LCI and the color difference of duodenal epithelium compared WLI (white light imaging) and LCI about medical examenees with gastroscopy

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Medical examinees with gastroscopy at Ebisu Heart Building Clicnic

Key exclusion criteria

1) Examinees who has been performed the operation of upper gastrointestine
2) Examinees who has gastrointestinal heredital diseases including familial adenomatous polyposis and hereditary non-polyposis colorectal cancer
3) Examinees who has severe organ failure
4) Examinees who is considered ungrammatical by the endoscopists

Target sample size

1200


Research contact person

Name of lead principal investigator

1st name Motohiko
Middle name
Last name Kato

Organization

Keio university, School of medicine

Division name

Center for Diagnostic and Therapeutic Endoscopy

Zip code

1608582

Address

35, Shinanomachi, Shinjuku, Tokyo

TEL

03-5363-3437

Email

moto28hiko@icloud.com


Public contact

Name of contact person

1st name Atsushi
Middle name
Last name Nakayama

Organization

Keio university, School of medicine

Division name

Cancer center

Zip code

1608582

Address

35, Shinanomachi, Shinjuku, Tokyo

TEL

03-5363-3437

Homepage URL


Email

anakayama34@keio.jp


Sponsor or person

Institute

Ebisu heart building clinic

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Comittee of Japan Gastointestinal Endoscopy Society

Address

3-2-1-4F, Kanda-Surugadai, Chiyoda-ku, Tokyo

Tel

03-3525-4670

Email

jges-rinri@jges.or.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2019 Year 01 Month 11 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

1200

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



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2018 Year 12 Month 27 Day

Date of IRB

2019 Year 06 Month 05 Day

Anticipated trial start date

2019 Year 09 Month 01 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Entry was delayed due to the COVID 19.


Management information

Registered date

2018 Year 12 Month 27 Day

Last modified on

2024 Year 01 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040320


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name