UMIN-CTR Clinical Trial

Public title

The evaluation of the relationship between microsurface pattern of gastric intestinal metaplasia visualized by magnifying endoscopy with narrow-band imaging and subtypes of intestinal metaplasia

Acronym

NBI IM study

Scientific Title

The evaluation of the relationship between microsurface pattern of gastric intestinal metaplasia visualized by magnifying endoscopy with narrow-band imaging and subtypes of intestinal metaplasia

Scientific Title:Acronym

NBI IM study

Region

Japan

Condition

chronic gastritis/ gastric intestinal metaplasia

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To clarify the frequency and pathological features of foveola-type intestinal metaplasia and groove-type intestinal metaplasia visualized by M-NBI in the stomach.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The differences in the ratio of complete intestinal metaplasia and incomplete intestinal metaplasia according to micro-mucosal pattern (foveola type, groove type).

Key secondary outcomes

1. The difference in the ratio of micro-mucosal pattern (foveola type, groove type) according to the localization of intestinal metaplasia.
2. The difference in the macroscopic type in white light imaging according to micro-mucosal pattern (foveola type, groove type).
3. The difference in color in white light imaging according to micro-mucosal pattern (foveola type, groove type).
4. The frequency of LBC by micro-mucosal pattern (foveola type, groove type).
5. The frequency of WOS by micro-mucosal pattern (foveola type, groove type).
6. The difference in the frequency of gastric epithelial tumors (including a history) with and without endoscopic intestinal metaplasia.
7. The Relationship between micro-mucosal pattern (foveola type, groove type) and H. pylori infection status (currently infected or already infected).
8. The difference in the extent of atrophic gastritis by micro-mucosal pattern (foveola type, groove type).
9. Intra-observer concordance rate and inter-observer concordance rate of micro-mucosal pattern (foveola type, groove type).
10. The differences in the ratio of complete intestinal metaplasia and incomplete intestinal metaplasia according to markers of intestinal metaplasia (LBC, WOS, MTB).

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients who give their informed consent to be involved in this study before the endoscopic examination.

Key exclusion criteria

1. Patients who are receiving warfarin or any anticoagulant treatment;
2. Patients who underwent gastrectomy
3. Patients with severe underlying disease.

Target sample size

100

Name of lead principal investigator

1st name	Kenshi
Middle name
Last name	Yao

Organization

Fukuoka University Chikushi Hospital

Division name

Endoscopy

Zip code

818-8502

Address

1-1-1, Zokumyoin, Chikushino City, Fukuoka

TEL

092-921-1011

Email

yao@fukuoka-u.ac.jp

Name of contact person

1st name	Takao
Middle name
Last name	Kanemitsu

Organization

Fukuoka University Chikushi Hospital

Division name

Endoscopy

Zip code

818-8502

Address

1-1-1, Zokumyoin, Chikushino City, Fukuoka

TEL

092-921-1011

Homepage URL

Email

t.kanemitsu93@gmail.com

Institute

Fukuoka University Chikushi Hospital, Department of Gastroenterology

Institute

Department

Personal name

Organization

Fukuoka University Chikushi Hospital, Department of Gastroenterology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Osaka International Cancer Institute, Department of Gastrointestinal Oncology

Name of secondary funder(s)

Organization

The ethics committee of Fukuoka University

Address

7-45-1, Nanakuma, Jonan Ward, Fukuoka City, Fukuoka

Tel

092-801-1011

Email

fumed-ethics@fukuoka-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

福岡大学筑紫病院（福岡）、大阪国際がんセンター（大阪）

Date of disclosure of the study information

2020

Year

07

Month

20

Day

URL releasing protocol

https://fukuoka.bvits.com/rinri/publish.aspx

Publication of results

Published

URL related to results and publications

https://fukuoka.bvits.com/rinri/publish.aspx

Number of participants that the trial has enrolled

150

Results

Primary endpoint
On multivariate analysis with adjustment for confounders, there was no independent association between micromucosal patterns and GIM subtypes (OR 0.87, 95% CI 0.27-2.7, p=0.805).

Secondary endpoint
Multivariate analysis demonstrated that incomplete GIM was independently associated with antral location (OR 3.7, 95% CI 1.5-9.3, p=0.006) and the presence of WOS (OR 43, 95% CI 3.8-491, p=0.002).

Results date posted

2026

Year

02

Month

27

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

A total of 98 patients with 156 lesions who provided informed consent between July 2020 and May 2021 and underwent white-light imaging and magnifying narrow-band imaging (M-NBI) were included in this study.

Participant flow

We enrolled patients with a history of endoscopic resection of GC or detailed inspection for suspicious or definite GC. The antrum greater curvature and corpus lesser curvature were regions of interest. Areas with endoscopic findings of light blue crest and/or white opaque substance (WOS) were defined as endoscopic GIM, and subsequent M-NBI was applied. Micromucosal pattern was classified into Foveola and Groove types, and targeted biopsies were performed on GIM with each pattern.

Adverse events

None

Outcome measures

The primary endpoint was to evaluate the association between micromucosal patterns of endoscopic GIM (Foveola and Groove types) and GIM subtypes. To elucidate independent association, multivariate analysis was performed using covariates including location (corpus and antrum); morphology (elevated, flat, and depressed); color (isochromatic, reddish, and whitish); LBC (present and absent); and WOS (present and absent).
The secondary endpoint was to identify endoscopic findings associated with incomplete GIM. To compare the strength of association among endoscopic findings, and clarify independency of association, multivariate analysis was also performed.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2020

Year

07

Month

01

Day

Date of IRB

2020

Year

07

Month

10

Day

Anticipated trial start date

2020

Year

07

Month

10

Day

Last follow-up date

2021

Year

05

Month

31

Day

Date of closure to data entry

2021

Year

05

Month

31

Day

Date trial data considered complete

Date analysis concluded

2023

Year

03

Month

31

Day

Other related information

no related information

Registered date

2020

Year

07

Month

15

Day

Last modified on

2026

Year

02

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046934