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

Second Affiliated Hospital, Zhejiang University, School of Medicine200 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

200

Conditions

Early Gastric Cancer Endoscopic Submucosal Dissection

Interventions

ESDPROCEDURE

Endoscopic Submucosal Dissection for early gastric cancer

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Second affiliated hospital, school of medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

scar area

the scar area after ESD for 1 year

Time frame: 1 year

Central Contacts

Yuqi Wang, Doctor

CONTACT

+86-15267019821 wyq@zju.edu.cn

Data from ClinicalTrials.gov

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