The Relationship Between Scar Formation and ESD Depth in Therapy for Gastric Carcinoma

Study Overview
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Brief Summary
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This study is a single-center, prospective, group-controlled clinical trial, aiming to clarify the relationship between the depth of dissection and scar formation in the treatment of early gastric cancer by ESD, and to provide high-quality evidence-based medicine for the treatment of early gastric cancer.

Detailed Description
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This project intends to compare the scar size of ESD for early gastric cancer with different peeling depths, explore the relationship between ESD peeling depth, scar formation and gastric function, and clarify the differential impact of different peeling depths on the prognosis of patients. We plan to provide evidence for guidelines of early gastric cancer ESD treatment based on the related data. In further, the project show insight into a more effective clinical technique which profit patients better prognosis.

Official Title
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The Relationship Between Scar Formation and ESD Depth in Therapy for Gastric Carcinoma

Conditions
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Early Gastric Cancer, Endoscopic Submucosal Dissection

Intervention / Treatment
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* Procedure: ESD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years old and younger than 75 years old. Early gastric cancer (T1a stage) diagnosed by gastroscopy or ultrasonography, differentiated and no ulcer; or early gastric cancer (T1a stage), differentiated with ulcer, lesion diameter <3cm; or early gastric cancer (T1a stage), undifferentiated and No ulcer, lesion diameter <2cm. Pathological diagnosis of gastric cancer. No further treatment is required. Patients diagnosed for the first time without other serious gastrointestinal diseases. Exclusion Criteria: Those who did not comply with the test requirements, obviously violated this protocol, or switched to other protocols in the middle of treatment. Advanced gastric cancer; or undifferentiated gastric cancer lesions > 2 cm in diameter; or differentiated gastric cancer with ulcer lesions > 3 cm in diameter. Coagulation disorders. Serious heart, liver, kidney and other diseases, can not tolerate ESD treatment. Patients with gastric cancer complications such as gastrointestinal bleeding and perforation that need emergency treatment. Patients with distant metastasis. Patients with other tumors, patients with a history of malignant tumors (except early carcinoma in situ. The patient himself requests to withdraw from the trial. The researcher believes that the patient is not suitable to participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: deep ESD group<br>Performed according to the ESD standard procedure, the depth of dissection includes the SM3 layer (submucosa 1/3 layer) | Procedure: ESD<br>* Endoscopic Submucosal Dissection for early gastric cancer<br>|
| Experimental: shallow ESD group<br>Performed according to the ESD standard procedure, the depth of dissection does not include the SM3 layer (submucosa 1/3 layer) | Procedure: ESD<br>* Endoscopic Submucosal Dissection for early gastric cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scar area | the scar area after ESD for 1 year | 1 year |