Endoscopic Submucosal Dissection Versus Esophagectomy for Early Esophageal Carcinoma

Completed

• Conditions: Esophageal Cancer
• Interventions: Procedure: Endoscopic submucosal dissection; Procedure: Esophagectomy

• Registration Number: NCT06060106
• Lead Sponsor: Changhai Hospital

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.

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2021-01-01
• Study Completion: 2023-01-01
• Study First Submitted: 2023-06-15
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-27
• Last Update Submitted: 2023-09-27
• Study First Posted: 2023-09-29
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endoscopic submucosal dissection	Endoscopic submucosal dissection	Early esophageal cancer patients treated with ESD
Esophagectomy	Esophagectomy	Early esophageal cancer patients treated with esophagectomy

Primary Outcome Measures

Name	Time	Method
overall survival (OS)	10 years	OS was measured from the date of ESD or esophagectomy until death from any cause
Recurrence free survival (RFS)	10 years	RFS was measured from the date of ESD or esophagectomy until the first recurrence or metastasis
Disease specific survival (DSS)	10 years	DSS was measured from the date of ESD or esophagectomy until death resulting from ESCC

Secondary Outcome Measures

Name	Time	Method
R0 resection	15 days	R0 resection was defined as horizontal and vertical margins free from both cancerous and precancerous tissues (HGIN), and without evidence of LVI. Pathological assessment was performed independently by two pathologists.
operation time	12 hours	Time from start to finish of operation, measured in minutes
adjuvant therapy	10 years	During follow-up, record whether Adjuvant therapy (i.e., additional endoscopy/surgery, radiotherapy and/or chemotherapy) was administered.
postoperative complications	30 days	Major postoperative complications includes bleeding, infection, and perforation，stricture and anastomotic leakage, adverse events assessed by blood tests, imageological examination and Endoscopic evaluation. Complications were graded according to the Clavien-Dindo classification system. The higher the complication grade, the more serious.
Post-operative hospitalization days	30 days	Date of discharge minus date of operation,measured in days

Trial Locations

Locations (1)

Changhai Hospital, Naval Medical University; 🇨🇳 Shanghai, China