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

21. mai 2026 oppdatert av: Gao, Pingting, Fudan University

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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Faktiske)

890

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kina
      • Shanghai, Kina
        • Zhongshan hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
ESD
Fremgangsmåte: 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
Fremgangsmåte: 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
Fremgangsmåte: Surgery
Surgery after ESD

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Presence of pathological indications for additional surgery
Tidsramme: 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).
Week1
Actual receipt of additional surgery
Tidsramme: 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.
Week 1

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Fudan University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

  • [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.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2020

Primær fullføring (Antatt)

1. juni 2026

Studiet fullført (Antatt)

1. juni 2026

Datoer for studieregistrering

Først innsendt

18. mai 2026

Først innsendt som oppfylte QC-kriteriene

21. mai 2026

Først lagt ut (Faktiske)

26. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • B2025-145(2); B2025-134

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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