Endoscopic Submucosal Dissection Versus Esophagectomy for Early Esophageal Carcinoma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Procedure: Endoscopic submucosal dissection
* Procedure: Esophagectomy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endoscopic submucosal dissection<br>Early esophageal cancer patients treated with ESD | Procedure: Endoscopic submucosal dissection<br>* The patient was positioned in the left lateral decubitus position.Marking dots were made with a dual knife/hybrid knife around the lesion, and a solution of glycerin fructose with indigo carmine was injected into the submucosal layer to lift the lesion. Finally, after pre-cutting of the mucosal and submucosal layers around the lesion and dissection of the submucosa, the lesion was removed en bloc.<br>|
| Esophagectomy<br>Early esophageal cancer patients treated with esophagectomy | Procedure: Esophagectomy<br>* The main surgical methods of esophagectomy include the McKeown operation, Lvor-lewis, Sweet and minimally invasive radical resection of esophageal cancer (MIE)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications | 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. | 30 days | 
| R0 resection | 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. | 15 days | 
| adjuvant therapy | During follow-up, record whether Adjuvant therapy (i.e., additional endoscopy/surgery, radiotherapy and/or chemotherapy) was administered. | 10 years | 
| operation time | Time from start to finish of operation, measured in minutes | 12 hours | 
| Post-operative hospitalization days | Date of discharge minus date of operation,measured in days | 30 days |