Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty Versus Esophagogastric Anastomosis for Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Gastroesophagus reflux disease apprised by ph monitoring
研究概览
简要总结
This research is designed to compare proximal gastrectomy anterior anastomosis with pyloroplasty with esophagogastric anastomosis for gastric cancer. Gastroesophageal reflux disease, postoperative quality of life, short term outcomes, and long term outcomes will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages.
- •Eastern Cooperative Oncology Group performance status of 0 or
- •Adequate organ function.
排除标准
- •Patients had distant metastasis.
- •oesophageal invasion of more than 3 cm.
- •Borrmann type 4 or large (more than 8 cm) type 3 carcinoma.
- •Previous chemotherapy or radiation therapy for any other malignancies.
研究组 & 干预措施
Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty (GAP)
The reconstruction including esophagogastric anastomosis and pyloroplasty for patients who underwent proximal gastrectomy . The anastomosis locate in the anterior of gastric stump.
干预措施: Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty (Procedure)
Control
The reconstruction including esophagogastric anastomosis and pyloroplasty for patients who underwent proximal gastrectomy . The anastomosis locate in the posterior or side of gastric stump.
干预措施: Proximal Gastrectomy Anterior Anastomosis With Pyloroplasty (Procedure)
结局指标
主要结局
Gastroesophagus reflux disease apprised by ph monitoring
时间窗: 6 months
Ph monitoring by wireless or wire device
Gastroesophagus reflux disease apprised by questionnaire
时间窗: 6 months
PGSAS-45 questionnaire is adopted.
次要结局
- Long-term outcome(5 years)
- Surgical complications of proximal gastrectomy for gastric cancer(1 year)
研究者
Yunhong Tian
Professor
Nanchong Central Hospital