NCT05526456

Brief Summary

With the deeper tumor invasion, the higher LNM rate beside the bilateral recurrent laryngeal nerves(RLN) was.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

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

February 1, 2012

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
Last Updated

September 2, 2022

Status Verified

August 1, 2022

Enrollment Period

10.2 years

First QC Date

August 31, 2022

Last Update Submit

August 31, 2022

Conditions

National Cancer Center/Cancer Hospital

Outcome Measures

Primary Outcomes (1)

  • LNM rates of the 207 thoracic T1N+ ESCC patients.

    2012.2-2022.4

Interventions

EsophagectomyPROCEDURE

McKeown, Ivor-Lewis, and Sweet procedure

Eligibility Criteria

Age44 Years - 73 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Among the 207 patients, 22 were in the T1a stage, whereas 185 were in the T1b stage. The invasion depth was EP in 2, LPM in 1, MM in 17, SM1 in 37, SM2 in 39 and SM3 in 97 patients

You may qualify if:

  • Our predefined search strategy identified pT1N+ ESCC cases without preoperative treatment, between February 2012 and April 2022.

You may not qualify if:

  • The patients were excluded because they were (1)less than 10 lymph nodes removed; (2) lacked specific sites of LNM; or (3) incomplete follow-up information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Esophagectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Study Record Dates

First Submitted

August 31, 2022

First Posted

September 2, 2022

Study Start

February 1, 2012

Primary Completion

April 30, 2022

Study Completion

May 15, 2022

Last Updated

September 2, 2022

Record last verified: 2022-08