Comparison of Billroth-I and Roux-en-Y Reconstruction After Distal Subtotal Gastrectomy for Gastric Cancer Patients : Prospective Randomized Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Reflux of bile content
研究概览
简要总结
The purpose of this trial is to compare the degree of reflux, operative outcomes and quality of life between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer
详细描述
Most common procedure for the resection of gastric cancers located in middle or lower stomach is distal subtotal gastrectomy. However, the optimal reconstruction procedure after that has still not to be established. Although B-I reconstruction is most common method due to the safety and simplicity, the duodenal fluid may reflux into the remnant stomach which may contribute to the mucosal injury to remnant stomach and esophagus. Roux en Y reconstruction may reduce the reflux to remnant stomach due to the length of Roux en Y limb, although it is more complicated procedure.
Therefore, we plan to collect 120 patients to compare the degree of reflux between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer. In addition, we compare the surgical outcome and quality of life between two groups.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with adenocarcinoma at the endoscopic biopsy
- •Patients who are possible to be performed curative resection in imaging study
- •Patients with tumor which not involved in pylorus and are located in mid or distal portion of the stomach
- •Patients with informed consent
- •Patients with three or less American Society Anesthesiology Score 3
排除标准
- •Patients who are or become pregnant
- •Patients with uncontrolled disease
- •Patient s with synchronous other malignancy
- •Patients participated in other clinical trial
结局指标
主要结局
Reflux of bile content
时间窗: 6 months after surgery
We estimate the degree of reflux by gastrofiberscopic findings using reflux score suggested by Romaganoli. In addition, histological finding of remnant stomach by endoscopic biopsy is also investigated. Reflux symptom is surveyed by Gastrointestinal Symptom Rating Scale.
次要结局
- Quality of Life(6 months after surgery)
- Morbidity(2 month after surgery)
- Anastomotic time(Day 1)
- Nutritional state(6 month after surgery)
- Mortality(2 month after operation)
- Operation time(Day 1)
研究者
Sang-Uk Han
Department of Surgery
Ajou University School of Medicine