UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026491
Receipt number R000030410
Scientific Title Prospective study of the comparison of the image enhanced endoscope in the endoscopic diagnosis of gastric cancer after Hp eradication
Date of disclosure of the study information 2017/04/01
Last modified on 2020/09/29 12:24:36

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Basic information

Public title

Prospective study of the comparison of the image enhanced endoscope in the endoscopic diagnosis of gastric cancer after Hp eradication

Acronym

the comparison of the image enhanced endoscope

Scientific Title

Prospective study of the comparison of the image enhanced endoscope in the endoscopic diagnosis of gastric cancer after Hp eradication

Scientific Title:Acronym

the comparison of the image enhanced endoscope

Region

Japan


Condition

Condition

gastric cancer or adenoma after Hp eradication

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

It examines the visibility of superiority or inferiority of gastric cancer or adenoma after Hp eradication in normal white light and the respective image enhanced endoscope using movie, aimed to reveal the appropriate selection and diagnostic methods of image enhanced endoscope.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Visibility for gastric cancer or adenoma after Hp eradication using endoscopic video

Key secondary outcomes

Relation between cancer visibility and clinicopathlogical features


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

The case with gastric cancer or adenoma after Hp eradication who will undergo endoscopic examination at Kyoto Prefectural University of Medicine and relative institutions.

Key exclusion criteria

Cases that principal investigator has determined to be inappropriate for this study.
Cases who are less than 20 years old

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Yuji
Middle name
Last name Naito

Organization

Kyoto Prefectural University of Medicine

Division name

Gastroenterology and Hepatology

Zip code

602-8566

Address

465 Kaji-cho, Kamijyo-ku, Kyoto, Japan

TEL

075-251-5519

Email

syokanai@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Osamu
Middle name
Last name Dohi

Organization

Kyoto Prefectural University of Medicine

Division name

Gastroenterology and Hepatology

Zip code

602-8566

Address

465 Kaji-cho, Kamijyo-ku, Kyoto, Japan

TEL

075-251-5519

Homepage URL


Email

osamu-d@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kyoto Prefectural University of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto Prefectural University of Medicine

Address

465 Kaji-cho, Kamijyo-ku, Kyoto, Japan

Tel

075-251-5337

Email

rinri@koto.kpu-m.ac.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

2017 Year 04 Month 01 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

30

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

Completed

Date of protocol fixation

2017 Year 03 Month 09 Day

Date of IRB

2017 Year 06 Month 28 Day

Anticipated trial start date

2017 Year 07 Month 01 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The LED light source WLI / LCI and the laser light source WLI / LCI are blindly randomized, and the endoscopist assesses the visibility of each image on a 4-point scale from 4 to 1. Using the visibility score to compare the visual superiority of LCI against WLI and the non-inferiority of LCI's visual superiority between LED and laser light source.


Management information

Registered date

2017 Year 03 Month 10 Day

Last modified on

2020 Year 09 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030410


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name