Randomized clinical study on diagnostic accuracy of magnified endoscopic examination with narrow band imaging (NBI) for small depressive lesion in the stomach

UMIN ID: UMIN000001072

Registered date:15/03/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Gastric cancer
• Date of first enrollment: 2008/06/01
• Target sample size: 1100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Magnified endoscopic examination with NBI system
Conventional non-magnified examination without NBI system

Outcome(s)

• Primary Outcome: Diagnostic accuracy
• Secondary Outcome: (1)Diagnostic sensitivity (2)Diagnostic specificity (3)Time required for confirming the endoscopic diagnosis (4)Added efficacy of magnified examination with NBI on conventional non-magnified examination without NBI (5)Frequency of endoscopically inconclusive lesions

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (a)Pathologically diagnosed lesion (b)The history of surgical gastric resection (c)Severe concomitant disease (d)User of anti-coagulant (e)Any other inappropriate condition for participating this study estimated by physician

Related Information

• Primary Sponsor: Innovation of New Diagnositic Modarities and Research on their diagnostic accuracy
• Source(s) of Monetary Support: Ministry of Health and Welfare