Study on gastric cancer diagnosis by endoscopy

Randomized controlled phase III trial of third-generation narrow band imaging and white light imaging in detecting the early gastric cancer and/or gastric adenoma - 3G-D final trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1032230613

Enrollment

6300

Registered

2024-02-01

Start date

2024-02-01

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

gastric cancer

Interventions

arm A:First observation:WLI + Second observation:NBI arm B:First observation:NBI + Second observation:WLI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) The age to obtain consent is 18 or older 2) Fulfill any of the following [1]-[3]. [1] Patients who have previously undergone endoscopic treatment for early gastric cancer or gastric adenoma and are currently being monitored at our site. [2] Patients who have not received treatment for early gastric cancer or gastric adenoma and are currently being monitored at their own site. [3] Patients who are scheduled to undergo an endoscopy for the purpose of detailed examination of gastric cancer or gastric adenoma. 3) It has been at least five months since the patient underwent endoscopy at your site. 4) Written informed consent has been obtained for participation in the study.

Exclusion criteria

Exclusion criteria: 1) Have a history of gastrectomy. 2) Have a history of gastric tube reconstruction after esophagectomy. 3) Received the test specified in the study less than 10 months (re-registration is possible if more than 10 months have passed). 4) Judged as inappropriate for carrying out this study, including the underlying disease.

Design outcomes

Primary

Measure	Time frame
Proportion of patients with gastric cancer and/or adenoma detected by non-magnifying endoscopy of the first observation	—

Secondary

Measure	Time frame
1) Proportion of patients with overlooked gastric cancer and/or adenoma (detected by non-magnifying endoscopy of the second observation) 2) Proportion of patients with gastric cancer detected by non-magnifying endoscopy of the first observation 3) Positive predictive value (PPV) for diagnosis of gastric cancer and/or adenoma in non-magnifying endoscopy of the first observation 4) Sensitivity and specificity of gastric cancer diagnosis by NBI with magnifying endoscoy 5) Proportion of adverse events 6) Observation time 7) Proportion of missed gastric epithelial neoplastic lesions 8) Proportion of patients with missed gastric epithelial neoplasms	—

Measure

Time frame

1) Proportion of patients with overlooked gastric cancer and/or adenoma (detected by non-magnifying endoscopy of the second observation) 2) Proportion of patients with gastric cancer detected by non-magnifying endoscopy of the first observation 3) Positive predictive value (PPV) for diagnosis of gastric cancer and/or adenoma in non-magnifying endoscopy of the first observation 4) Sensitivity and specificity of gastric cancer diagnosis by NBI with magnifying endoscoy 5) Proportion of adverse events 6) Observation time 7) Proportion of missed gastric epithelial neoplastic lesions 8) Proportion of patients with missed gastric epithelial neoplasms

—

Contacts

Public ContactTomohiro Kadota

National Cancer Center Hospital East

tkadota@east.ncc.go.jp+81-4-7133-1111

Outcome results

None listed

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