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

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.

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Key information

Conditions

Esophageal Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ESD

Procedure

Endoscopic submucosal dissection (ESD) is a minimally invasive endoscopic technique used for en bloc resection of superficial gastrointestinal neoplasms. The procedure is performed under conscious sedation or general anesthesia using a therapeutic endoscope. After lesion characterization and marking of the resection margins, a submucosal injection solution (e.g., saline mixed with epinephrine, dye, or viscous agents such as hyaluronic acid) is administered to lift the lesion from the muscularis propria. A circumferential mucosal incision is then made using an endoscopic knife, followed by meticulous submucosal dissection to separate the lesion from the underlying muscle layer. Hemostasis is achieved throughout the procedure using coagulation forceps or hemostatic devices as needed. The lesion is removed en bloc whenever possible, and the resected specimen is retrieved for histopathological evaluation. Post-resection inspection of the artificial ulcer is performed to assess for bleeding

Surgery

Procedure

Surgery after ESD

Primary outcomes

Presence of pathological indications for additional surgery

Time frame: Week1

According to current guidelines, non-curative resection requiring consideration of additional radical treatment was defined by the presence of submucosal invasion (SM2 invasion), or lymphovascular invasion (LVI-positive), or a positive vertical resection margin (VM-positive).
Actual receipt of additional surgery

Time frame: Week 1

Actual receipt of additional surgery was defined as patients who underwent subsequent radical surgical treatment after ESD based on multidisciplinary team (MDT) recommendations, clinician judgment, and patient preference.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2026
Study completion: 2026
First posted: May 26, 2026
Registry last updated: May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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