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Completed

NCT Number: NCT06060106

Endoscopic Submucosal Dissection Versus Esophagectomy for Early Esophageal Carcinoma

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.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Observational

Primary location

Changhai Hospital, Naval Medical University

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic submucosal dissection

Procedure

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

Procedure

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

Primary outcomes

  1. overall survival (OS)

    Time frame: 10 years

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

  2. Disease specific survival (DSS)

    Time frame: 10 years

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

  3. Recurrence free survival (RFS)

    Time frame: 10 years

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

Secondary outcomes

  1. 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.

  2. 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.

  3. adjuvant therapy

    Time frame: 10 years

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

  4. operation time

    Time frame: 12 hours

    Time from start to finish of operation, measured in minutes

  5. Post-operative hospitalization days

    Time frame: 30 days

    Date of discharge minus date of operation,measured in days

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2021
Study completion
2023
First posted
Sep 29, 2023
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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