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Multimodal Al for Precision Diagnosis of Esophageal Cancer

14 augustus 2026 bijgewerkt door: Quan-Lin Li, Shanghai Zhongshan Hospital
This study intends to construct two multimodal deep learning models: one for the diagnosis of esophageal cancer and the prediction of invasive depth to assess suitability for endoscopic resection; the other model, based on this, classifies endoscopic non-resectable patients into different degrees of invasion to further explore the differences in the sensitivity and survival of AI-predicted benign and malignant tumors in patients' responses to NAT, thereby providing reliable decision support for precise individualized treatment. This aspect has rarely been addressed in previous studies.

Studie Overzicht

Toestand

Beëindigd

Conditie

Studietype

Observationeel

Inschrijving (Werkelijk)

264

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Shanghai, China
        • Zhongshan hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

The study population will consist of adult patients (≥18 years) with pathologically confirmed esophageal squamous cell carcinoma (ESCC) who underwent diagnostic endoscopy and contrast-enhanced CT examination at participating centers. Patients with early-stage disease who received endoscopic resection or esophagectomy and had pathological assessment of tumor invasion depth will be included for development and validation of a multimodal deep learning model for diagnosis and prediction of invasion depth. Patients with locally advanced disease who received neoadjuvant therapy followed by surgical resection, with available pathological response and follow-up data, will be included for development and validation of a multimodal model for predicting treatment response and prognosis. Clinical information, CT images, endoscopic images, pathological findings, and survival outcomes will be collected for analysis.

Beschrijving

Inclusion Criteria:

  • Age ≥18 years.
  • Histologically confirmed or clinically suspected esophageal squamous cell carcinoma (ESCC).
  • Availability of pre-treatment endoscopic images and contrast-enhanced chest/upper abdominal CT scans.
  • Availability of complete clinical and pathological data.
  • Patients who underwent endoscopic resection (ESD/EMR) or esophagectomy with pathological assessment of tumor invasion depth.
  • Adequate image quality for analysis.
  • Written informed consent (for prospective cohorts, if applicable).

Exclusion Criteria:

  • Histology other than squamous cell carcinoma.
  • Prior treatment for esophageal cancer before baseline imaging, including chemotherapy, radiotherapy, immunotherapy, or endoscopic resection.
  • Distant metastatic disease at diagnosis.
  • Incomplete clinical, imaging, or pathological data.
  • Poor-quality CT or endoscopic images unsuitable for analysis.
  • History of another active malignancy within the past 5 years.
  • Recurrent esophageal cancer.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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
Additional surgery refers to esophagectomy with regional lymph node dissection performed after non-curative endoscopic resection. The procedure is recommended for patients with pathological risk factors for lymph node metastasis, including deep submucosal invasion, lymphovascular invasion, positive vertical resection margins, or other non-curative resection criteria. Surgical treatment is performed according to institutional standards and current clinical guidelines.
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
NAT +surgery
Neoadjuvant therapy has become a standard treatment strategy for patients with locally advanced esophageal squamous cell carcinoma (ESCC). Administered before surgical resection, neoadjuvant treatment aims to reduce tumor burden, downstage disease, increase the likelihood of complete (R0) resection, and improve long-term survival outcomes. Current neoadjuvant approaches include chemotherapy, chemoradiotherapy, and more recently, immune checkpoint inhibitor-based combination therapies. Among these, neoadjuvant immunochemotherapy has demonstrated promising pathological response rates and survival benefits, emerging as an important treatment option for ESCC. However, treatment response varies considerably among patients, highlighting the need for reliable predictive models to guide individualized therapeutic decision-making.
Additional surgery refers to esophagectomy with regional lymph node dissection performed after non-curative endoscopic resection. The procedure is recommended for patients with pathological risk factors for lymph node metastasis, including deep submucosal invasion, lymphovascular invasion, positive vertical resection margins, or other non-curative resection criteria. Surgical treatment is performed according to institutional standards and current clinical guidelines.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Actual receipt of additional surgery
Tijdsspanne: 1 week
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.
1 week
Presence of pathological indications for additional surgery
Tijdsspanne: 1 week
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).
1 week

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 maart 2023

Primaire voltooiing (Werkelijk)

1 januari 2026

Studie voltooiing (Werkelijk)

7 juni 2026

Studieregistratiedata

Eerst ingediend

1 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

1 juni 2026

Eerst geplaatst (Werkelijk)

5 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

14 augustus 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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