AI-assisted endoscopic ultrasound to grade how deep early esophageal cancer has grown

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective, randomized cohort study compares an AI-assisted endoscopic ultrasound (EUS) approach with conventional EUS interpretation for grading invasion depth in early esophageal squamous cell carcinoma. Approximately 200 eligible patients will be centrally randomized into an AI group or a conventional group, with about 100 patients per arm. The main outcome is grading accuracy of invasion depth compared with pathological results, with additional focus on pathological consistency and implications for preoperative T staging. Allocation is centrally randomized and labeled as A or B for operating physicians, and procedures occur at three participating hospitals in Fujian Province.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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.

Where it's running

• Fujian provincial hospital
  Fuzhou, Fujian, China Recruiting
• Affiliated Hospital of Putian University
  Putian, Fujian, China Not yet recruiting
• Putian First Hospital
  Putian, Fujian, China Not yet recruiting
• Putian Hospital of Traditional Chinese Medicine
  Putian, Fujian, China Not yet recruiting
• Xianyou County General Hospital
  Putian, Fujian, China Not yet recruiting

Study contacts

• Principal investigator: Wei Liang, MD — Fujian Provincial Hospital
• Study coordinator: Wei Liang, MD
• Email: fjsllw@163.com
• Phone: +86 -18120888996

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.