Phase III Study on Comparison for Bile Reflux and Gastric Stasis in Patients With Gastric Cancer After Distal Gastrectomy
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 90
- 试验地点
- 10
- 主要终点
- Bile reflux by Dual scintigraphy
研究概览
简要总结
The purpose of this study is to evaluate the degree of bile reflux and gastric stasis according the reconstruction methods after distal subtotal gastrectomy for gastric cancer, and to find out the proper method. We collect ninety patients who undergo distal gastrectomy for gastric cancers for this study from 5 institutions and randomly divide into 3 groups according to reconstruction methods: 1) Billroth-II (B-II), 2) Roux en Y gastrojejunostomy (RY-GJ) and 3) uncut Roux en Y gastrojejunostomy (uncut RY-GJ).
详细描述
Patients who have undergone gastrectomy for gastric cancer might be developed various symptoms by gastric stasis and bile reflux, it so called "post-gastrectomy syndrome", because of the diminishment of stomach capacity, the decrease of expulsive ability and the change of food passage. Until now, that had been accepted as the inevitable results after gastric resection. However, the survival rate has recently been increased owing to the increased proportion of early gastric cancer. And thus, to improve the quality of life of patients, many researchers have been actually studying for the reconstruction methods which are able to minimize the symptom by gastrectomy, but it is dissatisfied until now. Thus, the purpose of this study is to evaluate the degree of bile reflux and gastric stasis according the reconstruction methods after distal subtotal gastrectomy for gastric cancer, and to find out the proper method.
We collect ninety patients who undergo distal gastrectomy for gastric cancers for this study from 5 institutions and randomly divide into 3 groups according to reconstruction methods: 1) Billroth-II (B-II), 2) Roux en Y gastrojejunostomy (RY-GJ) and 3) uncut Roux en Y gastrojejunostomy (uncut RY-GJ). We evaluate the postoperative morbidity rate and then the degree of bile reflux, gastric emptying time and quality of life through long term follow-up using the gastrofiberscope, survey and so on.
From this study, we would suggest the standard reconstruction procedure after distal gastrectomy.
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
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent distal gastrectomy for adenocarcinoma of stomach with following criteria:
- •have cancer located in middle or distal portions
- •preoperative staged as cT1N0M0 or cT2N0M0 by computed tomography and gastrofiberscope (Endoscopic ultrasound, optionally)
- •have The American Society of Anaesthesiologists (ASA) score of three and less
排除标准
- •Patients following criteria:
- •have simultaneously other cancer
- •underwent cancer therapy (radiologic or immunologic or chemotherapeutic method) at past time
- •have systemic inflammatory disease
- •have upper gastrointestinal surgery
- •have the gastric cancer with obstruction
- •get pregnancy
- •are treating diabetics with Insulin
- •are participating or participated within 1 month in other clinical trials
- •have BMI less than 25
- •are expected to perform laparoscopy assisted gastrectomy
结局指标
主要结局
Bile reflux by Dual scintigraphy
时间窗: six month and one year after operation
次要结局
- Residual food, gastritis, bile reflux and reflux esophagitis by Gastrofiberscope findings(six month and one year after operation)
- Quality of life by EORTC QLQ30, STO22(one year after operation)
- Morbidity and Mortality(In hosipital)
- Gastric emptying time by Dual scintigraphy(six month and one year after operation)