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3G-detection trial

An exploratory randomized controlled trial evaluating the efficacy and safety of third-generation narrow band imaging, texture and color enhancement imaging, and white light imaging in detecting the early gastric cancer and/or gastric adenoma - 3G-detection trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032210213
Enrollment
900
Registered
2021-07-30
Start date
2021-08-12
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,esophageal cancer

Interventions

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

Sponsors

Yano Tomonori
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Aged 20 to 85 years old at the time of obtaining consent. 2)Fulfill any of the following [1]-[3]. [1]Have a history of endoscopic treatment for early gastric cancer and/or gastric adenoma, and endoscopic examination is scheduled on the purpose of follow-up. [2]Have a history of endoscopic treatment, chemotherapy, or radiotherapy for esophageal cancer, and endoscopic examination is scheduled on the purpose of follow-up. [3]Has a lesion diagnosed as gastric cancer, gastric adenoma, or esophageal cancer, and endoscopic examination is scheduled on the purpose of detailed examination. 3)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)Judged as inappropriate for carrying out this study, including the underlying disease.

Design outcomes

Primary

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

Secondary

MeasureTime 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 (including near-focus mode) 5)Defect rate 6)Proportion of adverse events 7)Observation time

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