UMIN-ICDS Clinical Trial

Public title

Multicenter Prospective Study on the Usefulness of Indigo Carmine Chromoendoscopy for Detecting Gastric Cancer and Adenoma During Upper Gastrointestinal Endoscopy

Acronym

Multicenter Study of Indigo Carmine Chromoendoscopy

Scientific Title

Multicenter Prospective Study on the Usefulness of Indigo Carmine Chromoendoscopy for Detecting Gastric Cancer and Adenoma during Surveillance Endoscopy

Scientific Title:Acronym

INDIGO study

Region

Japan

Condition

early gastric cancer and gastric adenoma

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study is to prospectively evaluate the usefulness of spraying indigo carmine throughout the entire stomach during surveillance endoscopy for detecting gastric cancer or adenomas.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

The proportion of individuals who were able to undergo indigo carmine spray (second round) and in whom early gastric cancer or gastric adenoma (one or more) was additionally detected among those who were able to undergo indigo carmine spray (second round).

Key secondary outcomes

1) False positive rate in biopsy
2) Detection rate of early gastric cancer and adenoma during the first observation (white light)
3) Increase in confidence in lesion detection using indigo carmine staining
4) Relationship between the degree of atrophy of the background gastric mucosa (Kimura-Takemoto classification) and tumor detection rate
5) Clinical and pathological characteristics of detected gastric tumors
6) Interval period between the previous and current endoscopic examinations
7) Adverse events during endoscopic examination

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

95

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Patients who meet at least one of the following criteria.
1. History of endoscopic treatment for gastric cancer or gastric adenoma
2. Currently diagnosed with early-stage gastric cancer, advanced gastric cancer, or gastric adenoma (known lesions are excluded)
2) Age: 20 years or older, 95 years or younger
3) Written informed consent has been obtained.

Key exclusion criteria

1) Patients after gastric or esophageal surgical resection
2) Patients who cannot undergo a biopsy
3) Pregnant patients

Target sample size

1050

Name of lead principal investigator

1st name	Kohei
Middle name
Last name	Takizawa

Organization

Kanagawa Cancer Center

Division name

Department of Gastroenterology

Zip code

241-8515

Address

2-3-3 Nakao, Asahi-ku, Yokohama, Kanagawa, Japan 241-8515

TEL

+81-45-520-2222

Email

koh.takizawa@gmail.com

Name of contact person

1st name	Takeshi
Middle name
Last name	Yasuda

Organization

Kyoto Prefectural University of Medicine

Division name

Molecular gastroenterology and hepatology

Zip code

602-8566

Address

465, Kawaramachi, Hirokoji, Kamigyoku, Kyoto, Japan

TEL

075-251-5519

Homepage URL

Email

t-yasuda@koto.kpu-m.ac.jp

Institute

Kanagawa Cancer Center

Institute

Department

Personal name

Organization

Other

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Kanagawa Cancer Center

Address

2-3-3 Nakao, Asahi-ku, Yokohama, Kanagawa, Japan

Tel

+81-45-520-2222

Email

koh.takizawa@gmail.com

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

2025

Year

11

Month

07

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

Open public recruiting

Date of protocol fixation

2025

Year

08

Month

20

Day

Date of IRB

2025

Year

11

Month

04

Day

Anticipated trial start date

2025

Year

11

Month

04

Day

Last follow-up date

2030

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Other evaluation items
1) Age, Sex
2) History of esophageal cancer or gastric cancer
3) Helicobacter pylori infection status (current infection, post-eradication, previously infected but no eradication history, unknown)
4) Use of sedatives or antispasmodics (including Minclear)
5) Indigo carmine concentration
6) Endoscopist's years of experience (specialist or not)
7) Type of endoscope used (Olympus, Fujifilm, Pentax)
8) Gastric observation time under white light, indigo carmine administration time, and gastric observation time under indigo carmine
9) Biopsy pathology results (Group 1, 2, 3, 4, 5, others)
10) Final pathology results if endoscopic resection or surgical resection was performed

Registered date

2025

Year

11

Month

07

Day

Last modified on

2025

Year

11

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066171