AI-assisted Endoscopic Ultrasound Grading of Early Esophageal Cancer Invasion Depth: A Multicenter, Prospective, Randomized Cohort Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFujian Provincial Hospital

About this trial

This study mainly uses an artificial intelligence system to assist in the classification of the depth of invasion of early esophageal squamous cell carcinoma under ultrasound endoscopy, providing a basis for preoperative T staging and diagnosis and treatment decisions.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Satisfy ①⑧⑨ and one of the following conditions simultaneously: ②③④⑤⑥⑦ ① Age over 18 years old, ② Esophageal ulcer, ③ low-grade intraepithelial neoplasia, ④ high-grade intraepithelial neoplasia, ⑤ patients with esophageal squamous cell carcinoma, ⑥ white patches of esophageal mucosa, ⑦ esophageal polyps, ⑧ with endoscopic examination records and detailed pathological records, ⑨ agree to participate in the study;

Disqualifiers

① Patients who have undergone esophageal cancer surgery, ② those with a history of radiotherapy and chemotherapy for esophageal cancer, ③ patients with missing data.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Artificial Intelligence system

    Device

    Use artificial intelligence to assist in the determination of the invasion depth of early esophageal squamous cell carcinoma under endoscopic ultrasound

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: AI GroupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The accuracy of grading judgment of infiltration depth

By comparing with the postoperative pathology, the accuracy of the preoperative T grading with the assistance of the artificial intelligence grading system was verified

Time frame
2 years

Secondary outcomes

1

survival rate

3-year survival rate

Time frame
Three years
2

Progression Free-Survival

The period from the start of treatment to tumor progression or death for any reason

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.