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SLND Versus Non-Dissection Following ESD for T1a Stage Esophageal Squamous Cell Carcinoma

Systematically Mediastinal Lymph Node Dissection (SLND) Versus Non-Dissection Following Endoscopic Submucosal Dissection (ESD) for T1a Stage Esophageal Squamous Cell Carcinoma

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06979986
Enrollment
102
Registered
2025-05-20
Start date
2025-06-01
Completion date
2027-04-01
Last updated
2025-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Brief summary

This is a study from Fujian Cancer Hospital Thoracic of Surgery Project, numbered as FJCHTOSP-1. Systematically mediastinal Lymph Node Dissection (SLD) Versus Non-Dissection Following Endoscopic Submucosal Dissection (ESD) for T1a Stage Esophageal Squamous Cell Carcinoma: a single-center, prospective clinical trial.

Detailed description

Participants will be evaluated for inclusion criteria and exclusion criteria, and then sign informal consent if desired. Participants will be randomly assigned to the intervention according to a prepared random tables. Participants in the systematically mediastinal lymph node dissection (SLND) group will receive systematically mediastinal lymph node dissection, while those in the non-SLND group will not receive mediastinal lymph node dissection. The primary endpoint is 3-year disease-free survival (DFS). The sample size are estimated with reference to investigators' previous data, in which the 3-year DFS was 62.7% for patients diagnosed with T1a Stage Esophageal Squamous Cell Carcinoma and underwent Endoscopic Submucosal Dissection without SLND. Investigators assumed that if 3-year DFS of patients in SLND group was over 80%, then investigatorswould deem the SLND group to be superior to the non-SLND group. The sample size are estimated to be 102. Therefore, the total number of patients enrolled are designed to be 102.

Interventions

PROCEDUREEndoscopic Submucosal Dissection with Systematically mediastinal Lymph Node Dissection

Participants will be evaluated for inclusion criteria and exclusion criteria, and then sign informal consent if desired. Participants will be randomly assigned to the intervention according to a prepared random tables. Participants in the SLND group will receive Endoscopic Submucosal Dissection with systematically mediastinal lymph node dissection

PROCEDUREEndoscopic Submucosal Dissection without SLND

Participants will be evaluated for inclusion criteria and exclusion criteria, and then sign informal consent if desired. Participants will be randomly assigned to the intervention according to a prepare random tables. Participants in the non-SLND group will just receive Endoscopic Submucosal Dissection treatment, not undergo Systematically mediastinal Lymph Node Dissection.

Sponsors

Fujian Cancer Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Clinical stage T1aN0M0. * A lesion detected on Endoscopic Ultrasound featured as T1a stage. * Age 18 to 75. * Patients who have signed the informed consent form.

Exclusion criteria

* • Other than invasive adenocarcinoma by pathological analysis. * Not complete resected or curative intent. * Patients who have history of other malignant tumors. * Patients who have history of thoracic surgery. * Patients who have received radiation, chemotherapy or other treatments previously.

Design outcomes

Primary

MeasureTime frameDescription
DFSFrom enrollment to the end of treatment at 3 yearsdisease-free survival

Contacts

Primary ContactRuirong Lin, Ph.D
lrr003@163.com0591-62752788
Backup ContactJiarong Zhang, Ph.D
lrrzgfj003@163.com0591-62752789

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026