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

NCT07074535 | Active Not Recruiting

• 1 other identifier: CEDREL-LNM
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Squamous Cell Cancer (SCC); Recurrent Laryngeal Nerve Palsy; Deep Learning; Postoperative Complication

Outcome Measures

Primary Outcomes (1)

• AUROC (Area Under the Receiver Operating Characteristic Curve)

  The discriminant ability of the comprehensive evaluation model at different thresholds (positive vs. negative)

  From enrollment to the end of treatment at 4 weeks

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients included were all esophageal cancer patients who received surgery and standard lymph node dissection in our hospital.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead

Study Sites (1)

Daping Hospital

Chongqing, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Vocal Cord Paralysis; Postoperative Complications

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: January 1, 2019
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

CN (1)