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

JRCT ID: jRCT1022190018

Registered date:24/01/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 24/01/2020
• Target sample size: 700
• Study type: Interventional

Intervention(s)

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 followed by BLI.

Outcome(s)

• Primary Outcome: Detection rate of esophageal squamous cell carcinoma in the first examination of BLI and LCI

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Koike Tomoyuki
• Secondary Sponsor: FUJIFILM Corporation