Endoscopic Submucosal Dissection Versus Esophagectomy for Early Esophageal Carcinoma

NCT06060106 | Completed DMC

• 1 other identifier: early esophageal carcinoma
• Study Type: observational
• Target: 191
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• postoperative complications

  30 days

• R0 resection

  15 days

• adjuvant therapy

  10 years

• operation time

  12 hours

• Post-operative hospitalization days

  30 days

Study Arms (2)

Endoscopic submucosal dissection

Early esophageal cancer patients treated with ESD

Procedure: Endoscopic submucosal dissection

Esophagectomy

Early esophageal cancer patients treated with esophagectomy

Procedure: Esophagectomy

Interventions

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.

Endoscopic submucosal dissection

Esophagectomy PROCEDURE

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

Esophagectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital, Naval Medical University

Shanghai, China

Location

Related Publications (4)

• Zhang Y, Ding H, Chen T, Zhang X, Chen WF, Li Q, Yao L, Korrapati P, Jin XJ, Zhang YX, Xu MD, Zhou PH. Outcomes of Endoscopic Submucosal Dissection vs Esophagectomy for T1 Esophageal Squamous Cell Carcinoma in a Real-World Cohort. Clin Gastroenterol Hepatol. 2019 Jan;17(1):73-81.e3. doi: 10.1016/j.cgh.2018.04.038. Epub 2018 Apr 25.

  PMID: 29704682 BACKGROUND

• An W, Liu MY, Zhang J, Cui YP, Gao J, Wang LP, Chen Y, Yang LX, Chen HZ, Jin H, Liu F, Chen J, Li ZS, Wang LW, Shi XG, Sun C. Endoscopic submucosal dissection versus esophagectomy for early esophageal squamous cell carcinoma with tumor invasion to different depths. Am J Cancer Res. 2020 Sep 1;10(9):2977-2992. eCollection 2020.

  PMID: 33042630 BACKGROUND

• Liu Z, Zhao R. Endoscopic Submucosal Dissection vs. Surgery for Superficial Esophageal Squamous Cancer: A Systematic Review and Meta-Analysis. Front Oncol. 2022 Apr 21;12:816832. doi: 10.3389/fonc.2022.816832. eCollection 2022.

  PMID: 35530330 BACKGROUND

• Qian M, Feng S, Zhou H, Chen L, Wang S, Zhang K. Endoscopic submucosal dissection versus esophagectomy for t1 esophageal squamous cell carcinoma: a propensity score-matched analysis. Therap Adv Gastroenterol. 2022 Nov 21;15:17562848221138156. doi: 10.1177/17562848221138156. eCollection 2022.

  PMID: 36458047 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Endoscopic Mucosal Resection; Esophagectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Wei An, Doctor

  Changhai Hospital, Naval Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology，Changhai Hospital；Academician of Chinese Academy of Engineering

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: September 29, 2023
• Study Start: January 1, 2011
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)