3G-detection trial

JRCT ID: jRCT1032210213

Registered date:30/07/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: gastric cancer,esophageal cancer
• Date of first enrollment: 12/08/2021
• Target sample size: 900
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Proportion of patients with gastric cancer and/or adenoma detected by non-magnifying endoscopy of the first observation

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Yano Tomonori
• Source(s) of Monetary Support: Olympus Corporation