CT and Endoscopic Biopsy Image-Based Deep Learning for Predicting Left Recurrent Laryngeal Nerve Lymph Node Metastasis in Esophageal Cancer

NCT07074535 — Active not recruiting, 500 participants, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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Registry	NCT07074535
Status	Active not recruiting
Study type	Observational
Enrollment	500 (Estimated)
Sponsor	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (Other)
Conditions	Esophageal Squamous Cell Cancer (SCC), Recurrent Laryngeal Nerve Palsy, Deep Learning, Postoperative Complication
Dates	start 2019-01-01, primary completion 2026-07-30 (estimated), completion 2027-12-30 (estimated), first posted 2025-07-20, last updated 2025-07-20
Locations	1 site in China

-Summary

The goal of this observational study is to develop a predictive model for left recurrent laryngeal nerve (RLN) lymph node metastasis using deep learning algorithms. The model will be developed using clinical data from previous esophageal cancer surgeries, including preoperative CT imaging, and histopathological images from gastroscopic biopsies. The model will also be validated through prospective clinical trials to guide the intraoperative lymph node dissection, thereby reducing postoperative risks of RLN injury.

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+Arms and interventions

Arm	Type	Interventions	Description
Left RLN lymph node （+）			Postoperative pathological results confirmed the metastasis of left recurrent laryngeal nerve lymph nodes.
Left RLN lymph node （-）			Postoperative pathological results confirmed the negative of left recurrent laryngeal nerve lymph nodes.

+Outcome measures

Primary outcomes

AUROC (Area Under the Receiver Operating Characteristic Curve) [From enrollment to the end of treatment at 4 weeks]: The discriminant ability of the comprehensive evaluation model at different thresholds (positive vs. negative)

+Eligibility

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

* Preoperative gastroscopic biopsy confirmed esophageal squamous cell carcinoma；
* The patient underwent esophagectomy with lymph nodes dissection along the left recurrent laryngeal nerve.

Exclusion Criteria:

* The patient's medical records are incomplete；
* The patient refused to participate in the trial.

+Locations (1)

Facility	City	Country	Status
Daping Hospital	Chongqing	China