Validation of the Japanese Esophageal Society classification for prediction of invasion depth of superficial squamous cell carcinoma in a Western populatio

Recruiting

• Conditions: All patients with a suspicious or known (pre)malignant esophageal squamous cell lesion

• Registration Number: NL-OMON26261
• Lead Sponsor: one

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 94

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Western patients with a suspicious or known (pre)malignant esophageal squamous cell lesion
- Photos and videos available using WLE, magnification endoscopy, NBI, and (when available) lugol’s iodine staining.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from any analysis with regard to the prediction of invasion depth:
- No data on histological invasion depth available.
- Patients who underwent esophagectomy with neoadjuvant (chemo)radiation therapy.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The overall accuracy of the JES-classification for predicting the invasion depth of ESCC

Secondary Outcome Measures

Name	Time	Method
-Presence and size of avascular areas in the esophageal squamous cell lesions.<br>-Paris-classification of the esophageal squamous cell lesions. <br>-Presence of intervascular background coloration.<br>-Positive/negative pink color sign with Lugol’s iodine staining. <br>-The predicted invasion depth of the esophageal squamous cell lesions considering the above mentioned parameters.<br>-Inter- and intraobserver agreement between Western expert endoscopists and non-expert endoscopists, and Japanese endoscopists.