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Active, not recruitingNCT07605663Updated May 26, 2026

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

An observational study in Esophageal Squamous Cell Carcinoma, sponsored by Fudan University. Active, not recruiting at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-26.

Sponsored by Fudan University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
890
Ages
40 Years to 80 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Esophageal Squamous Cell Carcinoma
03

In context

Esophageal Squamous Cell Carcinoma

645 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 275 are open to participants now.

This study's enrollment of 890 is above the median of 270 across 93 observational studies indexed under Esophageal Squamous Cell Carcinoma.

Browse Esophageal Squamous Cell Carcinoma studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
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.

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

Exclusion Criteria:

  • Poor-quality endoscopic images;
  • Previous esophageal surgery, neoadjuvant chemoradiotherapy, or other malignant tumors;
  • Missing pathological invasion depth data;
  • Synchronous distant metastasis.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
890 participants (actual)
Patient registry
No

Groups and cohorts

  • ESD

    Procedure: ESD

  • ESD+surgery

    Procedure: ESD · Procedure: Surgery

Interventions

  • ProcedureESD

    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

  • ProcedureSurgery

    Surgery after ESD

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Week1

  2. 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.

    Time frame: Week 1

07

Study locations

1 site
  • Zhongshan Hospital
    Shanghai, China
08

References and documents

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.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07605663
Lead sponsor
Fudan University
Responsible party
Gao, Pingting (Associate Chief Physician, Fudan University) — Principal investigator
First posted
May 26, 2026
Start date
Jan 1, 2020
Primary completion
Jun 1, 2026 (estimated)
Completion
Jun 1, 2026 (estimated)
Last update
May 26, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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