SLND Versus Non-Dissection Following ESD for T1a Stage Esophageal Squamous Cell Carcinoma
NCT ID: NCT06979986
Last Updated: 2025-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
102 participants
INTERVENTIONAL
2025-06-01
2027-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Endoscopic Submucosal Dissection with Systematically mediastinal Lymph Node Dissection
T1a Stage Esophageal Squamous Cell Carcinoma undergo Endoscopic Submucosal Dissection with Systematically mediastinal Lymph Node Dissection
Endoscopic 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
Endoscopic Submucosal Dissection without Systematically mediastinal Lymph Node Dissection
T1a Stage Esophageal Squamous Cell Carcinoma just recieve Endoscopic Submucosal Dissection treatment, not undergo Systematically mediastinal Lymph Node Dissection
Endoscopic 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.
Interventions
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Endoscopic 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
Endoscopic 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.
Eligibility Criteria
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Inclusion Criteria
* A lesion detected on Endoscopic Ultrasound featured as T1a stage.
* Age 18 to 75.
* Patients who have signed the informed consent form.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Fujian Cancer Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Weimin Fang
Role: PRINCIPAL_INVESTIGATOR
Central Contacts
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References
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Other Identifiers
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FJCHTOSP-1
Identifier Type: -
Identifier Source: org_study_id
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