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
1100 participants
OBSERVATIONAL
2025-07-21
2030-07-21
Brief Summary
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Detailed Description
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Our prior research demonstrated that complete right thoracic lymph node dissection significantly enhances long-term survival compared to incomplete left thoracic dissection (1). However, extended three-field dissection offered no survival advantage over conventional two-field dissection (2), necessitating further refinement of the latter's scope. Current preoperative diagnostics for lymph node metastasis suffer from limited sensitivity (3). During traditional two-field dissection, removing subcarinal lymph nodes (located below the carina) may compromise tracheobronchial blood supply, increasing risks of postoperative cough and pneumonia. Our retrospective study revealed a low subcarinal metastasis rate of approximately 2% (4). The risk factors and long-term prognostic impact of subcarinal metastasis remain unclear, requiring prospective studies to validate the necessity of this nodal station dissection.
This prospective study aims to investigate the incidence and risk factors of subcarinal lymph node metastasis within conventional dissection ranges, 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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observation group
All patients who had surgery due to esophageal cancer with curative intent, no intervention was applied.
no intervention was applied as observation study
no intervention was applied as observation study
Interventions
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no intervention was applied as observation study
no intervention was applied as observation study
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-2009
Identifier Type: -
Identifier Source: org_study_id
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