UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032323
Receipt number R000036859
Scientific Title Randomized controlled study for delineating early gastric cancer by white light imaging (WLI) and narrow-band imaging (NBI)
Date of disclosure of the study information 2018/05/01
Last modified on 2022/10/24 10:54:15

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Basic information

Public title

Randomized controlled study for delineating early gastric cancer by white light imaging (WLI) and narrow-band imaging (NBI)

Acronym

NBI-WLI study

Scientific Title

Randomized controlled study for delineating early gastric cancer by white light imaging (WLI) and narrow-band imaging (NBI)

Scientific Title:Acronym

NBI-WLI study

Region

Japan


Condition

Condition

early gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Comparison between concordance rates of WLI and NBI in delineating early gastric cancer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison between concordance rates of WLI and NBI in delineating early gastric cancer.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

white light imaging

Interventions/Control_2

narrow-band imaging

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

1) En bloc resection in ESD.
2) Histopathological diagnosis is gastric cancer.
3) Gastric cancer within a diameter of 30mm.

Key exclusion criteria

1) Histopathological diagnosis is impossible due to ESD.
2) Endoscopic diagnosis is impossible due to mucus and bleeding .
3) Histopathological diagnosis don't correspond endoscopic diagnosis.
4) Horizontal cut ends is not free of malignant tissue.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kenshi
Middle name
Last name Yao

Organization

Fukuoka University Chikushi Hospital

Division name

Department of Endoscopy

Zip code

818-8502

Address

1-1-1, Zokumyoin, Chikushino-city, Fukuoka, Japan

TEL

092-921-1011

Email

yao@fukuoka-u.ac.jp


Public contact

Name of contact person

1st name Toshiki
Middle name
Last name Kojima

Organization

Fukuoka University Chikushi Hospital

Division name

Department of gastroenterology

Zip code

818-8502

Address

1-1-1, Zokumyoin, Chikushino-city, Fukuoka, Japan

TEL

092-921-1011

Homepage URL


Email

toshiki55imari@yahoo.co.jp


Sponsor or person

Institute

Fukuoka University Chikushi Hospital

Institute

Department

Personal name



Funding Source

Organization

no

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

Fukuoka University Chikushi Hospital

Address

1-1-1, Zokumyoin, Chikushino-city, Fukuoka, Japan

Tel

092-921-1011

Email

toshiki55imari@yahoo.co.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

福岡大学筑紫病院


Other administrative information

Date of disclosure of the study information

2018 Year 05 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


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 11 Month 17 Day

Date of IRB

2017 Year 11 Month 17 Day

Anticipated trial start date

2017 Year 11 Month 18 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 04 Month 19 Day

Last modified on

2022 Year 10 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036859


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name