The Relationship Between Scar Formation and ESD Depth in Therapy for Gastric Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- scar area
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
scar area
时间窗: 1 year
the scar area after ESD for 1 year
次要结局
未报告次要终点