Clinical Value and Efficacy Index of Lymphadenectomy for... | NCT05604664

Studies
Clinical Value and Efficacy Index of Lymphadenectomy for Thoracic Escc

NCT05604664

Sponsor

Yongtao Han

Status

Completed

Last Update Posted

Nov 4, 2022Actual

Enrollment

1,727Actual

Phase

Not provided

Conditions

Esophageal Cancer

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2022Actual

Primary Completion Date

Oct 1, 2022Actual

Completion Date

Oct 10, 2022Actual

First Submitted Date

Oct 29, 2022

First Submission Date that Met QC Criteria

Nov 2, 2022

First Posted Date

Nov 3, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2022

Last Update Posted Date

Nov 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,727Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
5-year survival rate of lymph nodes metastases (%) in patients	Surgical data were retrospectively collected	2010.1.1-2017.12.30

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sichuan Cancer Hospital and Research Institute		Chengdu	Sichuan	610041	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004938	Esophageal Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided