Endoscopic Submucosal Dissection Versus Esophagectomy for Early Esophageal Carcinoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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.
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| 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)
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Outcome Measures
Primary Outcome Measures
- overall survival (OS) [10 years]
OS was measured from the date of ESD or esophagectomy until death from any cause
- Disease specific survival (DSS) [10 years]
DSS was measured from the date of ESD or esophagectomy until death resulting from ESCC
- Recurrence free survival (RFS) [10 years]
RFS was measured from the date of ESD or esophagectomy until the first recurrence or metastasis
Secondary Outcome Measures
- postoperative complications [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.
- R0 resection [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.
- adjuvant therapy [10 years]
During follow-up, record whether Adjuvant therapy (i.e., additional endoscopy/surgery, radiotherapy and/or chemotherapy) was administered.
- operation time [12 hours]
Time from start to finish of operation, measured in minutes
- Post-operative hospitalization days [30 days]
Date of discharge minus date of operation,measured in days
Eligibility Criteria
Criteria
Inclusion Criteria:
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Mucosal or submucosal squamous cell carcinoma of the esophagus
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no lymph node involvement or distant metastasis on computed tomography (CT) or pathology;
Exclusion Criteria:
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Tis premalignant lesions (high-grade intraepithelial neoplasia;HGIN)
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patients with neoadjuvant therapy
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patients combined with severe diseases of other organs
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Changhai Hospital, Naval Medical University | Shanghai | China |
Sponsors and Collaborators
- Changhai Hospital
Investigators
- Principal Investigator: Wei An, Doctor, Changhai Hospital, Naval Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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. Erratum In: Clin Gastroenterol Hepatol. 2020 Mar;18(3):758.
- early esophageal carcinoma