Effect of Gastrectomy and Anastomosis on Chronic Metabolic Disease Such as Diabetes and Hypertension in Early Gastric Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Proportion of patients who quit previous medication for hypertension because of improved disease
研究概览
简要总结
The purpose of this study is to determine whether the extent of gastrectomy and anastomosis type affect chronic metabolic disease such as diabetes and hypertension in early gastric cancer patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven primary gastric adenocarcinoma
- •clinical stage Ia or Ib examined with endoscopy, endoscopic ultrasound, and computed tomography
- •aged 20-80 year old,
- •performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
- •diagnosed as diabetes or hypertension
- •patients planning to undergo gastrectomy or endoscopic submucosal dissection
- •written informed consent
排除标准
- •having high risk for operation such as severe heart disease, severe respiratory disease
- •previous abdominal surgery or radiation therapy
- •proven more advanced disease than pathological stage II requiring adjuvant chemotherapy
结局指标
主要结局
Proportion of patients who quit previous medication for hypertension because of improved disease
时间窗: 5 years after operation
Proportion of patients who quit previous medication for hypertension because of improved disease among the patients who diagnosed as early gastric cancer and hypertension
Proportion of patients who quit previous medication for diabetes because of improved disease
时间窗: 5 year after operation
proportion of patients who quit their previous medication for diabetes because of improved disease after operation among all patients who underwent gastrectomy for early gastric cancer with diabetes.
次要结局
- difference of proportion of patients who quit previous medication for diabetes between patients who underwent subtotal gastrectomy and those who underwent total gastrectomy(5 years after operation)
- difference of serum levels of c-peptide, Ghrelin, GIP, GLP-1, glucagon, insulin between before and after operation(1 years after operation)
- difference of proportion of patients who quit previous medication for diabetes according to anastomosis(5 year after operation)
- difference of proportion of patients who quit previous medication for hypertension according to anastomosis(5 years after operation)
- difference of proportion of patients who quit previous medication for hypertension between patients who underwent subtotal gastrectomy and those who underwent total gastrectomy(5 years after operation)
研究者
Keun Won Ryu
Principal Investigator
National Cancer Center, Korea