an AI-Driven Four-Tier Invasion Depth Classification for Early Esophageal Cancer

Fudan University

Status

Active, not recruiting

Conditions

Esophageal Squamous Cell Carcinoma

Treatments

Procedure: Surgery

Procedure: ESD

Study type

Observational

Funder types

Other

Identifiers

NCT07605663

B2025-145(2) B2025-134;

Details and patient eligibility

About

The goal of this retrospective observational study is to evaluate whether preoperative endoscopic imaging can accurately assess tumor invasion depth in patients with early esophageal neoplasia undergoing endoscopic submucosal dissection (ESD).

The main question it aims to answer is:"How accurately can preoperative multimodal endoscopic imaging predict histopathological invasion depth in early esophageal squamous cell carcinoma and high-grade intraepithelial neoplasia?" If there is a comparison group: Not applicable (no intervention or arm comparison was specified; analyses are based on diagnostic performance against postoperative pathology as the reference standard).

Participants will:

Be retrospectively identified from two tertiary hospitals in China;
Have pathologically confirmed early esophageal squamous cell carcinoma or high-grade intraepithelial neoplasia treated with ESD;
Have complete postoperative pathology data including invasion depth, lesion size, location, lymphovascular invasion, and margin status;
Have preoperative high-quality endoscopic images (white-light imaging, narrow-band imaging, iodine staining, and blue laser imaging);
Undergo retrospective image-pathology correlation analysis to assess diagnostic performance of invasion depth assessment.

Enrollment

890 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Pathologically confirmed EEC or high-grade intraepithelial neoplasia;
Underwent ESD with complete postoperative pathological report;
Preoperative high-quality WLI, NBl, iodine staining and BLI endoscopic images;
complete clinical data.

Exclusion criteria

Poor-quality endoscopic images;
Previous esophageal surgery, neoadjuvant chemoradiotherapy, or other malignant tumors;
Missing pathological invasion depth data;
Synchronous distant metastasis.