Clinical Study of Double-Endoscopic Combined With Minimally Invasive Treatment for Early Gastric Cancer at Clinical Stage T1b
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Rate of recurrence
研究概览
简要总结
For patients diagnosed with early gastric cancer involving submucosal invasion, super-ESD indications, or lymph node metastasis, a combination of preoperative endoscopic ultrasound and abdominal contrast-enhanced CT was utilized to ascertain the depth of tumor invasion and to identify any suspicious metastatic lymph nodes in the vicinity of the stomach. Subsequently, a local full-thickness resection, coupled with or followed by individualized precise lymph node dissection, was conducted to fulfill the following objectives: ① To investigate the safety, feasibility, and efficacy of local resection for patients meeting super-ESD criteria; ② To offer a clinical foundation for the individualized and precise lymph node dissection treatment of early gastric cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years old;
- •Endoscopic pathological diagnosis: adenocarcinoma;
- •Enhanced abdominal CT combined with endoscopic ultrasound clinical staging: T1bN0-1M
- •Has not received other treatment;
- •No other serious comorbidities;
- •Agree to participate in the study and sign the informed consent form.
排除标准
- •Pregnant or breastfeeding women
- •History of previous abdominal surgery
- •History of other previous malignancies
- •Can patients with severe heart, lung, brain diseases tolerate surgical treatment
研究组 & 干预措施
Group A
Patients in group A-No lymph node metastasis, who underwent simple Double-Endoscopic Combined with local full-thickness resection.
干预措施: Sixty patients with early gastric cancer in stage T1bN0-1M0 were divided into Group A-N0 and Group B-N + according to the presence or absence of lymph node metastasis. When the enrolled patients und (Procedure)
Group B
Patients in group B-imaging examination showed lymph node metastasis. patients were randomly divided into Group N + a and Group N + b.
Group N + a: Local full-thickness gastric wall and lymph nodes dissection on D1 or D1 + were performed with Double-Endoscopic Group N + b: Traditional standard surgical gastrectomy and D1 or D1 + lymph nodes dissection was performed .
干预措施: Sixty patients with early gastric cancer in stage T1bN0-1M0 were divided into Group A-N0 and Group B-N + according to the presence or absence of lymph node metastasis. When the enrolled patients und (Procedure)
结局指标
主要结局
Rate of recurrence
时间窗: Within 2 years
次要结局
- The operation time, complications and hospital stay were recorded(30 days)
研究者
Qun Zhao
Professor
Hebei Medical University