Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1852 participants
OBSERVATIONAL
2025-07-21
2030-07-21
Brief Summary
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Detailed Description
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curative surgery includes tumor resection, digestive tract reconstruction, and thorough lymph node dissection. Our previous studies demonstrated that complete right thoracic lymph node dissection significantly improves long-term survival compared to incomplete left thoracic dissection (1). However, extended three-field lymph node dissection did not show survival benefits over conventional two-field dissection (2). Therefore, the precise scope of two-field lymph node dissection in esophageal cancer requires further refinement.
Current preoperative diagnostic methods for lymph node metastasis in esophageal cancer suffer from limited sensitivity (3). In traditional two-field dissection, removing the left tracheobronchial lymph nodes may compromise blood supply to the trachea and bronchi, increase the risk of recurrent laryngeal nerve injury, and elevate postoperative complications such as cough and pneumonia. Our retrospective study on left tracheobronchial lymph node (106TBL) metastasis revealed a low transfer rate of approximately 2% (4). The risk factors for 106TBL metastasis and its long-term prognostic impact remain unclear, necessitating prospective studies to validate the necessity of this nodal station dissection.
This study aims to prospectively investigate the incidence and risk factors of tracheobronchial lymph node metastasis within the conventional dissection range, providing robust evidence for personalized treatment strategies in esophageal cancer.
Reference:
1. Li B, Hu H, Zhang Y, et al. Extended Right Thoracic Approach Compared With Limited Left Thoracic Approach for Patients With Middle and Lower Esophageal Squamous Cell Carcinoma: Three-year Survival of a Prospective, Randomized, Open-label Trial. Ann Surg . 2018 May;267(5):826-832.
2. Li B, Zhang Y, Miao L, et al. Esophagectomy With Three-Field Versus Two-Field Lymphadenectomy for Middle and Lower Thoracic Esophageal Cancer: Long-Term Outcomes of a Randomized Clinical Trial. J Thorac Oncol . 2021 Feb;16(2):310-317.
3. Li B, Li N, Liu S, et al. Does \[18F\] fluorodeoxyglucose-positron emission tomography/computed tomography have a role in cervical nodal staging for esophageal squamous cell carcinoma? J Thorac Cardiovasc Surg . 2020 Aug;160(2):544-550.
4. Lin K, Li B, Sun Y, et al. Precise pattern of lymphatic spread of esophageal squamous cell carcinoma: results of 1074 patients with N1 disease. J Cancer Res Clin Oncol . 2023 Nov;149(17):15819-15825
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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prospective observation cohort
All patients who had surgery due to esophageal cancer with curative intent, no intervention was applied.
No Intervention: Observational Cohort
no intervention was applied in this cohort
Interventions
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No Intervention: Observational Cohort
no intervention was applied in this cohort
Eligibility Criteria
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Inclusion Criteria
* clinical staging: cT1-4a N0/+ M0.
* no history of other malignancy.
Exclusion Criteria
* poor physical status to have esophagectomy.
20 Years
85 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Haiquan Chen
Director, Institute of Thoracic Oncology, Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ECTOP-2010
Identifier Type: -
Identifier Source: org_study_id
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