Study on gastric cancer diagnosis by endoscopy

JRCT ID: jRCT1032230613

Registered date:01/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: gastric cancer
• Date of first enrollment: 01/03/2024
• Target sample size: 6300
• Study type: Interventional

Intervention(s)

arm A:First observation:WLI + Second observation:NBI
arm B:First observation:NBI + 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
5) Proportion of adverse events
6) Observation time

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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 six months since the patient underwent endoscopy at your site.
4) 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) Received the test specified in the study less than 12 months (re-registration is possible if more than 12 months have passed).
4) 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