Optical biopsy for esophageal squamous cell neoplasia by using endocytoscopy

Not Applicable

• Conditions: early esophageal squamous cell carcinoma

• Registration Number: JPRN-UMIN000037383
• Lead Sponsor: Hokkaido University Hospital

Brief Summary

Fifteen of the 78 patients were diagnosed as having undetected new pharyngeal lesions in the (endoscopic surveillance during treatment (ESDT) and 10 (12.8%) (95% CI: 6.9 - 22.2%) were histopathologically confirmed to have new lesions of pharyngeal SCC or HGD. Among the 13 lesions of SCC or HGD, 8 were found by NBI observation; however, 5 were undetectable using NBI but detectable by lugol staining. All of the 13 lesions had endoscopic findings of pink color sign on lugol staining.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-25
• Study Completion: 2020-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Not provided

Exclusion Criteria

Exclusion criteria were as follows: 1) with histological diagnosis of SCC by prior endoscopic biopsy, 2) unsuitability as subjects, 3) age < 20 years, and 4) current pregnancy.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of endoscopic diagnosis by using endocytoscopy.

Secondary Outcome Measures

Name	Time	Method
1)Rate of evaluable ultra-high magnifying images. 2)Specificity of endoscopic diagnosis by using endocytoscopy. 3)Accuracy of endoscopic diagnosis by using endocytoscopy.