Optical biopsy for esophageal squamous cell neoplasia by using endocytoscopy

Optical biopsy for esophageal squamous cell neoplasia by using endocytoscopy - ENEC study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000037383

Enrollment

200

Registered

2019-07-25

Start date

2019-06-20

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

early esophageal squamous cell carcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The study subjects included patients who underwent ER for ESCC or were treated for head and neck cancer at the Hokkaido University Hospital and Keiyukai daini hospital, or were refered to the 2 hospitals for the lesions suspicious for early ESCC. The inclusion criteria of this study were as follows: 1) who have background mucosa with multiple minute iodine unstained areas (high risk group for metachronous ESCC), and 2) written informed consent obtained from the patient.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Sensitivity of endoscopic diagnosis by using endocytoscopy.	—

Secondary

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

Countries

Japan

Contacts

Public ContactMasaki Inoue

Hokkaido University Hospital Department of Gastroenterology

mokomokomomon@gmail.com011-716-1161

Outcome results