MedPath

3G-detection trial

Phase 2
Conditions
gastric cancer,esophageal cancer
Registration Number
JPRN-jRCT1032210213
Lead Sponsor
Yano Tomonori
Brief Summary

Efficacy analysis (primary endpoint) detection rate of gastric epithelial tumor lesions in non-magnification observation at initial observation (comparison of 3 groups) was Group B (NBI) 7.3% > Group C (TXI) 5.0%, and B Group (NBI) exceeded the control group A (WLI) by 5.6% by more than 1.0%. Based on this, group B (NBI) is a more promising observation method and was judged to be appropriate as the observation group for the next confirmatory study.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
901
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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