Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000059685
Enrollment
1050
Registered
2025-11-07
Start date
2025-11-04
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

early gastric cancer and gastric adenoma

Interventions

None listed

Sponsors

Kanagawa Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactTakeshi Yasuda

Kyoto Prefectural University of Medicine Molecular gastroenterology and hepatology

t-yasuda@koto.kpu-m.ac.jp075-251-5519

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026