NCT05570487

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

2 months

First QC Date

October 4, 2022

Last Update Submit

October 24, 2022

Conditions

Keywords

esophageal cancerlympha nodes

Outcome Measures

Primary Outcomes (1)

  • The number of lymph nodes

    Surgical data were retrospectively collected

    2010.1.1-2017.12.30

Study Arms (4)

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

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

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

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

Interventions

Since the data were collected retrospectively, there were no interventions

N+A GroupN+B GroupN0A GroupN0B 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;
  • Histologically confirmed primary thoracic esophageal squamous cell carcinoma,
  • Staging PT1-4A, N0-3, M0 AJCC eighth edition;
  • Excluding lymph node dissection \< 15,(meeting the guideline criteria)

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

RECRUITING

Related Publications (2)

  • Li K, Leng X, Peng L. Resected lymph nodes and survival of patients with esophageal squamous cell carcinoma in pT2 and pT3. Int J Surg. 2024 Mar 1;110(3):1879-1881. doi: 10.1097/JS9.0000000000001023. No abstract available.

  • Li K, Leng X, He W, Du K, Li C, Liu K, Wang C, Liu G, Li Z, Jiang L, Li K, Zhou Q, Li J, Luo X, Nie X, Lu S, Li H, Fang Q, Xiao W, Han Y, Peng L. Resected lymph nodes and survival of patients with esophageal squamous cell carcinoma: an observational study. Int J Surg. 2023 Jul 1;109(7):2001-2009. doi: 10.1097/JS9.0000000000000436.

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
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 4, 2022

First Posted

October 6, 2022

Study Start

October 1, 2022

Primary Completion

December 1, 2022

Study Completion

October 1, 2023

Last Updated

October 25, 2022

Record last verified: 2022-10

Locations