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

NCT07605663 | Active Not Recruiting

• 1 other identifier: B2025-145(2); B2025-134
• Study Type: observational
• Target: 890
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

ESD

Procedure: ESD

ESD+surgery

Procedure: ESD; Procedure: Surgery

Interventions

Surgery PROCEDURE

Surgery after ESD

ESD+surgery

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

ESD; ESD+surgery

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, China

Location

Related Publications (1)

• [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.

  BACKGROUND

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 26, 2026
• Study Start: January 1, 2020
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)