Comparison study for detection of GI neoplasia between LCI and NBI

JRCT ID: jRCT1012200006

Registered date:04/11/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients who had previously upper gastrointestinal epithelial neoplasia
• Date of first enrollment: 30/11/2020
• Target sample size: 770
• Study type: Interventional
• Intervention(s): endoscopy equipment used (LCI or NBI)

Outcome(s)

• Primary Outcome: To verify whether the ratio of the number of diagnosed epithelial neoplastic lesions including the pharynx, esophagus and stomach by LCI observation is significantly higher than that by NBI observation.

Secondary Outcome

Ratio of the number of diagnosed neoplastic lesions with WLI
Ratio of the patients of diagnosed neoplastic lesions with WLI in LCI group and NBI group
Ratio of the patients of diagnosed neoplastic lesions by site
Ratio of the patients of diagnosed neoplastic lesions by size
Ratio of the patients of diagnosed neoplastic lesions by morphorogy
Obsevation time
Serious adverse events
Diagnostic accuracy of GI neoplasia
Ratio of the number of diagnosed neoplastic lesions with experts and non-experts

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 89age old
• Gender: Both
• Include criteria: Patients who receive surveilance endpscopy during study period.

Exclude criteria

Patients who can not receive biopsy
Patients for whom consent cannot be obtained
Patients who cannot confirm intention due to dementia or consciousness disorder
Patients who are judged to be inappropriate subjects by reseachers

Related Information

• Primary Sponsor: Ono Shoko