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A trial for early detection of esophageal cancer by image-enhanced endoscopy

A multicenter randomized controlled trial for early detection of esophageal squamous cell carcinoma by blue light imaging and linked color imaging

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1022190018
Enrollment
700
Registered
2020-01-24
Start date
2020-01-24
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 cancer Esophageal cancer

Interventions

In the BLI group, lesions in the pharynx, larynx, and esophagus were examined using BLI followed by LCI. In the LCI group, lesions in the pharynx, larynx, and esophagus were examined using LCI followe

Sponsors

Koike Tomoyuki
Lead Sponsor
FUJIFILM Corporation
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients with high risk for esophageal cancer (those after endoscopic resection or radiation therapy for esophageal cancer, those with pharyngeal/laryngeal cancer, and those after endoscopic resection or radiation therapy for pharyngeal/laryngeal cancer) (2) Patients with performance status 0-2

Exclusion criteria

Exclusion criteria: (1) Patients with a history of surgery of pharynx, larynx, or esophagus (2) Patients that it is difficult to perform esophageal biopsy (3) Patients that it is difficult to perform endoscopy (4) Patients with an allergy for iodine (5) Patients with pregnance, those within 28 days after childbirth, or those with breastfeeding (6) Patients with severe mental disease (7) Patients who do not agree with participation of this study

Design outcomes

Primary

MeasureTime frame
Detection rate of esophageal squamous cell carcinoma in the first examination of BLI and LCI

Secondary

MeasureTime frame
1) Detection rate of esophageal squamous cell carcinoma in the second examination of BLI and LCI 2) Detection rate of esophageal squamous cell carcinoma in the combination of first and second examinations of BLI and LCI 3) Sensitivity and specificity of esophageal squamous cell carcinoma in BLI and LCI 4) Detection rate, sensitivity, and specificity of pharyngeal/laryngeal squamous cell carcinoma in BLI and LCI 5) Sensitivity, and specificity of lugol-voiding lesion in BLI and LCI 6) Endoscopic features (color, morphology) of esophageal and pharyngeal/laryngeal squamous cell carcinoma in BLI and LCI 7) Detection rate, sensitivity, and specificity of esophageal and pharyngeal/laryngeal squamous cell carcinoma in BLI and LCI among patients with/without the history of radiation therapy 8) Detection rate, sensitivity, and specificity of esophageal squamous cell carcinoma in BLI and LCI in high/low confidence 9) Detection rate, sensitivity, and specificity of esophageal squamous cell carcinoma in BLI and LCI in each lugol-voiding lesion grade 10) Missing rate of esophageal squamous cell carcinoma in the first examination in BLI and LCI

Contacts

Public ContactWaku Hatta

Tohoku University Hospital

waku-style@festa.ocn.ne.jp+81-22-717-7171

Outcome results

None listed

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