Prospective evaluation of autofluoroscence imaging endoscopy for screening of squamous mucosal high-grade neoplasia in the esophagus

UMIN ID: UMIN000002148

Registered date:01/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Esophageal neoplasia
• Date of first enrollment: 2009/07/01
• Target sample size: 380
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Endoscopic screening using AFI was performed.
Endoscopic screening using AFI was performed by experienced and less-experienced endoscopists.

Outcome(s)

• Primary Outcome: The primary outcome variable in this study was the sensitivity of AFI on a per lesion basis.
• Secondary Outcome: (1) The positive predictive value (PPV) of NBI in a per lesion basis; (2) the sensitivity, specificity, PPV, negative predictive value (NPV) and accuracy of AFI in a per patient basis. (3) The differences in sensitivities, specificities, NPVs, PPVs and accuracy with regard to study periods, endoscopists, lesions' size and HGIN or invasive cancer.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients were excluded if they had previously undergone an operation, chemotherapy or radiotherapy for esophageal cancer, or had undergone chromoendoscopy with iodine staining within 6 months or allergic to iodine solution.

Related Information

• Primary Sponsor: Osaka Medical Center for Cancer and Cardiovascular Diseases
• Secondary Sponsor: N/A
• Source(s) of Monetary Support: Osaka Medical Center for Cancer and Cardiovascular Diseases,N/A