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Clinical Trials/NCT06060106
NCT06060106
Completed
Not Applicable

Endoscopic Submucosal Dissection Versus Esophagectomy for Early Esophageal Carcinoma:a Cohort Study

Changhai Hospital1 site in 1 country191 target enrollmentJanuary 1, 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophageal Cancer
Sponsor
Changhai Hospital
Enrollment
191
Locations
1
Primary Endpoint
overall survival (OS)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Endoscopic submucosal dissection (ESD) is a minimally invasive alternative to esophagectomy for early esophageal squamous cell carcinoma (EESCC), The data of EESCC patients who received ESD or esophagectomy were retrospectively analyzed,The aim of this study was to compare the efficacy and safety of ESD and esophagectomy in EESCC,Risk factors affecting the prognosis of patients with early esophageal squamous cell carcinoma were analyzed.

Detailed Description

Endoscopic submucosal dissection (ESD) is a minimally invasive alternative to esophagectomy for early esophageal squamous cell carcinoma (EESCC).The aim of this study was to compare the efficacy and safety of ESD and esophagectomy in EESCC,The data of EESCC patients who received ESD or esophagectomy were retrospectively analyzed. Overall survival (OS), disease specific survival (DSS), recurrence free survival (RFS), and procedure-related variables were compared between ESD and esophagectomy patients.Risk factors affecting the prognosis of patients with early esophageal squamous cell carcinoma were analyzed.

Registry
clinicaltrials.gov
Start Date
January 1, 2011
End Date
January 1, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zhaoshen Li

Director of Gastroenterology,Changhai Hospital;Academician of Chinese Academy of Engineering

Changhai Hospital

Eligibility Criteria

Inclusion Criteria

  • Mucosal or submucosal squamous cell carcinoma of the esophagus
  • no lymph node involvement or distant metastasis on computed tomography (CT) or pathology;

Exclusion Criteria

  • Tis premalignant lesions (high-grade intraepithelial neoplasia;HGIN)
  • patients with neoadjuvant therapy
  • patients combined with severe diseases of other organs

Outcomes

Primary Outcomes

overall survival (OS)

Time Frame: 10 years

OS was measured from the date of ESD or esophagectomy until death from any cause

Recurrence free survival (RFS)

Time Frame: 10 years

RFS was measured from the date of ESD or esophagectomy until the first recurrence or metastasis

Disease specific survival (DSS)

Time Frame: 10 years

DSS was measured from the date of ESD or esophagectomy until death resulting from ESCC

Secondary Outcomes

  • R0 resection(15 days)
  • operation time(12 hours)
  • adjuvant therapy(10 years)
  • postoperative complications(30 days)
  • Post-operative hospitalization days(30 days)

Study Sites (1)

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