Endoscopic Submucosal Dissection Versus Esophagectomy for Early Esophageal Carcinoma

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06060106
• Other study ID #: early esophageal carcinoma
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: January 1, 2023

Study information

• Verified date: September 2023
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Changhai Hospital, Naval Medical University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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