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.

Study Overview

• Status: Active, not recruiting
• Conditions: Esophageal Squamous Cell Carcinoma
• Intervention / Treatment: Procedure: ESD; Procedure: Surgery

• Study Type: Observational
• Enrollment (Actual): 890

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Zhongshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients diagnosed with esophageal neoplasms and treated with endoscopic submucosal dissection (ESD) at 2 hospitals, the Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital (Shanghai and Xiamen), between the January, 2020 and January, 2026 were prospectively enrolled in this study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ESD	Procedure: ESD; 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
ESD+surgery	Procedure: ESD; 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; Procedure: Surgery; Surgery after ESD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of pathological indications for additional surgery	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).	Week1
Actual receipt of additional surgery	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.	Week 1

Collaborators and Investigators

• Sponsor: Fudan University

Publications and helpful links

General Publications

• [1] FERLAY J, COLOMBET M, SOERJOMATARAM I, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries [J]. CA Cancer J Clin, 2021, 71(3): 209-49. [2] EUROPEAN SOCIETY OF GASTROINTESTINAL E. ESGE clinical guideline for the diagnosis and treatment of early esophageal cancer [J]. Endoscopy, 2023, 55(7): 649-67. [3] JAPANESE ESOPHAGEAL S. Japanese guidelines for the treatment of esophageal cancer 2022 edition [J]. Esophagus, 2022, 19(1): 1-124. [4] WANG Z, LI Y, ZHANG M, et al. Non-curative endoscopic submucosal dissection for early esophageal squamous cell carcinoma: risk factors and clinical outcomes [J]. J Gastroenterol Hepatol, 2023, 38(10): 1892-9.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Esophageal Diseases; Carcinoma; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma; Surgical Procedures, Operative
• Other Study ID Numbers: B2025-145(2); B2025-134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No