Billroth-II Modified and Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer: an Open-label Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Reflux esophagistis
研究概览
简要总结
There are Billroth-I, Billroth-II, Billroth-II with Braun, and Roux-en-Y reconstruction after distal gastrectomy.
Hypothesis: Billroth-II modified method is non-inferior to Roux-en-Y method in terms of reducing reflux esophagitis after distal gastrectomy for gastric cancer patients.
详细描述
Since the first gastrectomy by Theodore Billroth in 1881, this procedure remained a curative treatment for gastric cancer. Reconstruction method after gastrectomy may affect complication rates, post-operative nutritional status, and quality of life (QoL). There are several reconstruction methods for distal gastrectomy, including Billroth I (B-I), Billroth II (B-II), Roux-en-Y (R-Y). B-I and B-II were considered better than R-Y in terms of shorten operation time and lessen blood loss due to technical simplicity. In contrast, R-Y was better in terms of preventing bile reflux and remnant gastritis, which can increase remnant stomach cancer and worsen QoL. However, long term QoL was similar between B-I and R-Y in some randomized controlled trials. Although bile reflux was higher in B-I and B-II groups, remnant gastric cancer was similar between 3 groups in this study. In brief, which one is the ideal reconstruction after distal gastrectomy is still controversial.
At our center, reconstruction after distal and sub-total gastrectomy including B-I, B-II, B-II with Braun anastomosis, and R-Y, depended mostly on surgeons' preferences. From 2018, to decrease bile reflux rate while not increasing operation time, we applied modified B-II technique with 3-5 sutures between the afferent loop to the gastric remnant. This study was conducted to evaluate the efficacy of this method by comparing it with the R-Y method.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients confirmed with gastric cancer
- •Indicated for radical distal gastrectomy (cT1 to cT4a, any N, M0; according to AJCC/UICC 8th TNM staging for gastric cancer)
- •Age from 18- to 80-year-old
- •Agreed to participate in study with written inform consent
排除标准
- •Pregnant patients
- •An American Society of Anesthesiology (ASA) score of higher than 4
- •Concurrent cancer or history of previous other cancers
- •Previous gastrectomy
- •Complications including bleeding, perforation required emergency gastrectomy
结局指标
主要结局
Reflux esophagistis
时间窗: on the 12th month after surgery
Findings of reflux esophagitis according to Los Angeles classification via endoscopy
次要结局
- Operative time(Intraoperative)
- Early complications(30 days after surgery)
- Post gastrectomy syndromes(from 30 days to 1 years after surgery)
- Serum total protein(on the 3rd, 6th, and 12th month after surgery)
- Changing of Residual food(on the 6th, and 12th month after surgery)
- 6th month reflux esophagistis(on the 6th month after surgery)
- Time for making anastomosis(Intraoperative)
- Blood loss(Intraoperative)
- Length of post-operative hospital stay(30 days after surgery or until mortality)
- Changing of bile reflux(on the 6th, and 12th month after surgery)
- Bodyweight(on the 3rd, 6th, and 12th month after surgery)
- Serum albumin(on the 3rd, 6th, and 12th month after surgery)
- Hemoglobin(on the 3rd, 6th, and 12th month after surgery)
- Changing of Gastric remnant gastritis(on the 6th, and 12th month after surgery)
- Changing of GSRS score(on the 3rd, 6th, and 12th month after surgery)