NCT05604664

Brief Summary

The goal of this observational study is to to clarify the focus of lymph node dissection during esophagectomy.. The main question\[s\] it aims to answer is:

  • provide a basis for accurate staging and the relationship between OS and lymph node dissection

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,727

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
19 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 3, 2022

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

October 29, 2022

Last Update Submit

November 3, 2022

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • 5-year survival rate of lymph nodes metastases (%) in patients

    Surgical data were retrospectively collected

    2010.1.1-2017.12.30

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

(1) Pathologic findings proved esophageal cancer (8th AJCC/UICC stage T1b-4aN0-3M0). (2) underwent esophagecomy (two-field or three-field LN dissection). (3)The primary tumor was thoracic esophageal cancer.

You may qualify if:

  • Pathologic findings proved ESCC (8th AJCC/UICC stage T1b-4aN0-3M0)
  • Underwent esophagecomy (two-field or three-field LN dissection)
  • The primary tumor was thoracic ESCC

You may not qualify if:

  • Located outside the thoracic
  • Patients underwent salvage or R1/R2 esophagecomy
  • The number of resected lymph nodes (RLNs) less than 15
  • With neoadjuvant therapy(NT) or salvage chemoradiotherapy(SCRT)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sichuan Cancer Hospital and Research Institute

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

October 29, 2022

First Posted

November 3, 2022

Study Start

May 1, 2022

Primary Completion

October 1, 2022

Study Completion

October 10, 2022

Last Updated

November 4, 2022

Record last verified: 2022-11

Locations

CN(1)