Endoscopic Submucosal Dissection Versus Esophagectomy for Early Esophageal Carcinoma

Changhai Hospital191 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

191

Conditions

Esophageal Cancer

Interventions

Endoscopic submucosal dissectionPROCEDURE

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.

EsophagectomyPROCEDURE

The main surgical methods of esophagectomy include the McKeown operation, Lvor-lewis, Sweet and minimally invasive radical resection of esophageal cancer (MIE)

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Changhai Hospital, Naval Medical University

Shanghai, China

Outcomes

Primary Outcomes

overall survival (OS)

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

Time frame: 10 years

Disease specific survival (DSS)

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

Time frame: 10 years

Recurrence free survival (RFS)

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

Time frame: 10 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: 15 days

adjuvant therapy

During follow-up, record whether Adjuvant therapy (i.e., additional endoscopy/surgery, radiotherapy and/or chemotherapy) was administered.

Time frame: 10 years

operation time

Time from start to finish of operation, measured in minutes

Data from ClinicalTrials.gov

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