Endoscopic Submucosal Dissection Versus Esophagectomy for Early Esophageal Carcinoma

September 27, 2023 updated by: Zhaoshen Li, Changhai Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

191

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Changhai Hospital, Naval Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with early esophageal cancer from January 2011 to January 2021 admitted to Changhai Hospital were included in this study.Patients treated with ESD were classified as the ESD group, and those who underwent radical esophageal cancer treatment were classified as the surgical group.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Endoscopic submucosal dissection
Early esophageal cancer patients treated with ESD
Procedure: Endoscopic submucosal dissection
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.
Esophagectomy
Early esophageal cancer patients treated with esophagectomy
Procedure: Esophagectomy
The main surgical methods of esophagectomy include the McKeown operation, Lvor-lewis, Sweet and minimally invasive radical resection of esophageal cancer (MIE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival (OS)
Time Frame: 10 years
OS was measured from the date of ESD or esophagectomy until death from any cause
10 years
Disease specific survival (DSS)
Time Frame: 10 years
DSS was measured from the date of ESD or esophagectomy until death resulting from ESCC
10 years
Recurrence free survival (RFS)
Time Frame: 10 years
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
Time Frame: 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.
30 days
R0 resection
Time Frame: 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.
15 days
adjuvant therapy
Time Frame: 10 years
During follow-up, record whether Adjuvant therapy (i.e., additional endoscopy/surgery, radiotherapy and/or chemotherapy) was administered.
10 years
operation time
Time Frame: 12 hours
Time from start to finish of operation, measured in minutes
12 hours
Post-operative hospitalization days
Time Frame: 30 days
Date of discharge minus date of operation,measured in days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Principal Investigator: Wei An, Doctor, Changhai Hospital, Naval Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

June 15, 2023

First Submitted That Met QC Criteria

September 27, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • early esophageal carcinoma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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