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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002148
Enrollment
380
Registered
2009-07-01
Start date
2009-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal neoplasia

Interventions

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

Sponsors

Osaka Medical Center for Cancer and Cardiovascular Diseases
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) patients with present esophageal neoplasias, (2) patients with past history of esophageal neoplasias treated with endoscopic resection, (3) patients with present or past history of head and neck cancer.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
The primary outcome variable in this study was the sensitivity of AFI on a per lesion basis.

Secondary

MeasureTime frame
(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.

Countries

Japan

Contacts

Public ContactRyu Ishihara

Osaka Medical Center for Cancer and Cardiovascular Diseases Department of Gastrointestinal Oncology

isihara-ry@mc.pref.osaka.jp06-6972-1181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026