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

Sponsor

Yongtao Han (Other)

Overall Status

Completed

CT.gov ID

NCT05617352

Collaborator

(none)

1,659

Enrollment

Location

5.3

Actual Duration (Months)

311.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Diagnostic Test: Since the data were collected retrospectively, there were no interventions

Study Design

Study Type:

Observational

Actual Enrollment :

1659 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

May 1, 2022

Actual Primary Completion Date :

Oct 1, 2022

Actual Study Completion Date :

Oct 10, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. Men and women aged 18-85 years
1. Histologically confirmed primary thoracic esophageal squamous cell carcinoma,
1. Staging PT1b-4A, N0-3, M0 AJCC eighth edition
1. Excluding lymph node dissection < 15, (meeting the guideline criteria)
1. 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
1. Patients with distant metastasis confirmed by imaging
1. Patients with obvious surgical contraindications.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sichuan Cancer Hospital	Chendu	Sichuan	China	610041

Sponsors and Collaborators

Yongtao Han

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yongtao Han, Clinical Professor, Sichuan Cancer Hospital and Research Institute

ClinicalTrials.gov Identifier:

NCT05617352

Other Study ID Numbers:

SCCH-TS2204

First Posted:

Nov 15, 2022

Last Update Posted:

Nov 21, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Study Results

No Results Posted as of Nov 21, 2022