The Impact of Two-field or Three-field Lymphadenectomy on Overall Survival in Middle and Lower Thoracic Esophageal Squamous Cell Carcinoma: An Observational Study

November 18, 2022 updated by: Yongtao Han

The Impact of Two-field or Three-field Lymphadenectomy on Overall Survival in Middle and Lower Thoracic Esophageal Squamous Cell Carcinoma: A Single Center Retrospective Analysis

To clarify the effect of Two-field or Three-field Lymphadenectomy on the survival of esophageal squamous cell carcinoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1659

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chendu, Sichuan, China, 610041
        • Sichuan Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 years
  • 2. Histologically confirmed primary thoracic esophageal squamous cell carcinoma,
  • 3. Staging PT1b-4A, N0-3, M0 AJCC eighth edition
  • 4. Excluding lymph node dissection < 15, (meeting the guideline criteria)
  • 5. The tumor located in the lower middle thoracic.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
2F Group
Patients with Two-field Lymphadenectomy
Diagnostic test: Since the data were collected retrospectively, there were no interventions
Since the data were collected retrospectively, there were no interventions
3F Group
Patients with Three-field Lymphadenectomy
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
Time Frame: 2010.1.1-2017.12.30
Surgical data were retrospectively collected
2010.1.1-2017.12.30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yongtao Han

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

October 10, 2022

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

November 7, 2022

First Posted (Actual)

November 15, 2022

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 18, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCCH-TS2204

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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