NCT05617352

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,659

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2022

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

November 7, 2022

Last Update Submit

November 18, 2022

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • The number of lymph nodes

    Surgical data were retrospectively collected

    2010.1.1-2017.12.30

Study Arms (2)

2F Group

Patients with Two-field Lymphadenectomy

Diagnostic Test: 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

Interventions

Since the data were collected retrospectively, there were no interventionsDIAGNOSTIC_TEST

Since the data were collected retrospectively, there were no interventions

2F Group3F Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with esophageal cancer and need surgical treatment.

You may qualify if:

  • \. Men and women aged 18-85 years
  • \. Histologically confirmed primary thoracic esophageal squamous cell carcinoma,
  • \. Staging PT1b-4A, N0-3, M0 AJCC eighth edition
  • \. Excluding lymph node dissection \< 15, (meeting the guideline criteria)
  • \. The tumor located in the lower middle thoracic.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sichuan Cancer Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 7, 2022

First Posted

November 15, 2022

Study Start

May 1, 2022

Primary Completion

October 1, 2022

Study Completion

October 10, 2022

Last Updated

November 21, 2022

Record last verified: 2022-11

Locations

CN(1)