Incidence of 106TBL Lymph Node Metastasis

NCT ID: NCT07165210

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1852 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-21

Study Completion Date

2030-07-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

the study was to document the incidence of left tracheobronchial lymph node metastasis, and the risk factors of metastasis.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Although the survival of esophageal cancer patients has improved with the application of chemotherapy, radiotherapy, and immunotherapy, esophageal surgery remains one of the procedures with a high risk of postoperative complications, despite significant advancements in surgical techniques in recent years.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

prospective observation cohort

All patients who had surgery due to esophageal cancer with curative intent, no intervention was applied.

No Intervention: Observational Cohort

Intervention Type OTHER

no intervention was applied in this cohort

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No Intervention: Observational Cohort

no intervention was applied in this cohort

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients with esophageal squamous cell carcinoma
* clinical staging: cT1-4a N0/+ M0.
* no history of other malignancy.

Exclusion Criteria

* esophageal cancer in the neck
* poor physical status to have esophagectomy.
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fudan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Haiquan Chen

Director, Institute of Thoracic Oncology, Fudan University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Bin Li, MD

Role: CONTACT

086-021-64175590-82500

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Bin Li, MD

Role: primary

086-021-64175590-82500

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ECTOP-2010

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.