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NCT Number: NCT06979986

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic Submucosal Dissection with Systematically mediastinal Lymph Node Dissection

Procedure

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

Endoscopic Submucosal Dissection without SLND

Procedure

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.

Primary outcomes

  1. DFS

    Time frame: From enrollment to the end of treatment at 3 years

    disease-free survival

Study contacts

Contact information is provided by the study sponsor or research team.

Jiarong Zhang, Ph.D

CONTACT

[email protected]

0591-62752789

Ruirong Lin, Ph.D

CONTACT

[email protected]

0591-62752788

Sponsors and collaborators

Lead sponsor

Fujian Cancer Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 20, 2025
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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