Clinical trial NCT06060106: Endoscopic Submucosal Dissection Versus Esophagectomy for Early Esophageal Carcinoma
Official title: Endoscopic Submucosal Dissection Versus Esophagectomy for Early Esophageal Carcinoma：a Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 191
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: overall survival (OS)
timeFrame: 10 years
measure: Disease specific survival (DSS)
timeFrame: 10 years
measure: Recurrence free survival (RFS)
timeFrame: 10 years
Secondary outcomes:
measure: postoperative complications
timeFrame: 30 days
measure: R0 resection
timeFrame: 15 days
measure: adjuvant therapy
timeFrame: 10 years
measure: operation time
timeFrame: 12 hours
measure: Post-operative hospitalization days
timeFrame: 30 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Naval Medical University
Study officials:
affiliation: Changhai Hospital, Naval Medical University
name: Wei An, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.