RESECTED LYMPH NODES AND SURVIVAL OF PATIENTS WITH ESOPHAGEAL SQUAMOUS CELL CARCINOMA: AN OBSERVATIONAL STUDY

NCT05570487 — Unknown, 1600 participants, Yongtao Han

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Increasing the Number of Resected Lymph Nodes Improves Overall Survival of Patients With Esophageal Squamous Cell Carcinoma With Positive Lymph Nodes: a Retrospective Analysis of 1656 Cases at a Single Cancer Center

Registry	NCT05570487
Status	Unknown
Study type	Observational
Enrollment	1600 (Estimated)
Sponsor	Yongtao Han (Other)
Conditions	the Records of Esophageal Cancer
Interventions	Since the data were collected retrospectively, there were no interventions (Diagnostic test)
Dates	start 2022-10-01, primary completion 2022-12-01 (estimated), completion 2023-10-01 (estimated), first posted 2022-10-06, last updated 2022-10-25
Locations	1 site in China

-Summary

To clarify the effect of the number of lymph node dissection and the number of stations on survival

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+Arms and interventions

Arm	Interventions	Description
N0A Group	Diagnostic Test: Since the data were collected retrospectively, there were no interventions	patients with negative lymph nodes and resected lymph nodes less than 15
N0B Group	Diagnostic Test: Since the data were collected retrospectively, there were no interventions	patients with negative lymph nodes and resected lymph nodes no less than 15
N+A Group	Diagnostic Test: Since the data were collected retrospectively, there were no interventions	patients with positive lymph nodes and resected lymph nodes less than 15
N+B Group	Diagnostic Test: Since the data were collected retrospectively, there were no interventions	patients with positive lymph nodes and resected lymph nodes no less than 15

Since the data were collected retrospectively, there were no interventions (Diagnostic test): Since the data were collected retrospectively, there were no interventions

+Outcome measures

Primary outcomes

The number of lymph nodes [2010.1.1-2017.12.30]: Surgical data were retrospectively collected

+Eligibility

Sex: All, ages: 18 Years to 90 Years

Inclusion Criteria:

1. Men and women aged 18-85;
2. Histologically confirmed primary thoracic esophageal squamous cell carcinoma,
3. Staging PT1-4A, N0-3, M0 AJCC eighth edition;
4. Excluding lymph node dissection < 15,(meeting the guideline criteria)

Exclusion Criteria:

1. Patients with a history of previous thoracic and abdominal surgery that may affect lymphatic reflux
2. Patients with distant metastasis confirmed by imaging;
3. Patients with obvious surgical contraindications.

+Locations (1)

Facility	City	Country	Status
Sichuan Cancer Hospital	Chengdu, Sichuan	China	Recruiting

+Publications

Results publication: Li K, Leng X, Peng L. Resected lymph nodes and survival of patients with esophageal squamous cell carcinoma in pT2 and pT3. Int J Surg. 2024 Mar 1;110(3):1879-1881. doi: 10.1097/JS9.0000000000001023. No abstract available. PMID 38116658
Results publication: Li K, Leng X, He W, Du K, Li C, Liu K, Wang C, Liu G, Li Z, Jiang L, Li K, Zhou Q, Li J, Luo X, Nie X, Lu S, Li H, Fang Q, Xiao W, Han Y, Peng L. Resected lymph nodes and survival of patients with esophageal squamous cell carcinoma: an observational study. Int J Surg. 2023 Jul 1;109(7):2001-2009. doi: 10.1097/JS9.0000000000000436. PMID 37222685