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

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

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

Study Overview

• Status: Recruiting
• Conditions: the Records of Esophageal Cancer
• Intervention / Treatment: Diagnostic test: Since the data were collected retrospectively, there were no interventions

• Study Type: Observational
• Enrollment (Anticipated): 1600

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chendu, Sichuan, China, 610041
      • Recruiting
      • Sichuan Cancer hospital
      • Contact: Yongtao Han; Phone Number: +8618702870755; Email: doc.leng@uestc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with esophageal cancer and need surgical treatment.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
N0A Group; patients with negative lymph nodes and resected lymph nodes less than 15	Diagnostic test: Since the data were collected retrospectively, there were no interventions; Since the data were collected retrospectively, there were no interventions
N0B Group; patients with negative lymph nodes and resected lymph nodes no less than 15	Diagnostic test: Since the data were collected retrospectively, there were no interventions; Since the data were collected retrospectively, there were no interventions
N+A Group; patients with positive lymph nodes and resected lymph nodes less than 15	Diagnostic test: Since the data were collected retrospectively, there were no interventions; Since the data were collected retrospectively, there were no interventions
N+B Group; patients with positive lymph nodes and resected lymph nodes no less than 15	Diagnostic test: Since the data were collected retrospectively, there were no interventions; Since the data were collected retrospectively, there were no interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of lymph nodes	Surgical data were retrospectively collected	2010.1.1-2017.12.30

Collaborators and Investigators

• Sponsor: Yongtao Han

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): October 1, 2023

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (ACTUAL): October 6, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: esophageal cancer; lympha nodes
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma
• Other Study ID Numbers: SichuanCHRIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We are willing to share data, analytic methods, and study materials related to this article with other researchers. Provided that all of the above will not be used for commercial or profit purposes. Other researchers can contact the corresponding author of this article by email and indicate the required research materials and purpose. We will be glad to provide relevant materials for this study after approval and discussion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No