Endoscopic Submucosal Dissection Versus Esophagectomy for Early Esophageal Carcinoma

NCT ID: NCT06060106

Last Updated: 2023-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

191 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-01

Study Completion Date

2023-01-01

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.

Conditions

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Esophageal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Endoscopic submucosal dissection

Early esophageal cancer patients treated with ESD

Endoscopic submucosal dissection

Intervention Type 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

Early esophageal cancer patients treated with esophagectomy

Esophagectomy

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Esophagectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

Director of Gastroenterology,Changhai Hospital;Academician of Chinese Academy of Engineering

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei An, Doctor

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital, Naval Medical University

Locations

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Changhai Hospital, Naval Medical University

Shanghai, , China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 29704682 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33042630 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35530330 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36458047 (View on PubMed)

Other Identifiers

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early esophageal carcinoma

Identifier Type: -

Identifier Source: org_study_id