Uncut Roux-en-y Anastomosis Reduce Postoperative Complication and Improve Nutritional Status After Distal Gastrectomy
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 832
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related gastrointestinal and gastroesophageal reflux as assessed by The Los Angeles and Savary-Miller systems for grading esophagitis
研究概览
简要总结
The investigators intend to conduct multi-center randomized controlled study to find if Uncut Roux-en-Y anastomosis to the distal gastric cancer patients after radical D2 can reduce the long-term complications, affect the quality of life, and improve the prognosis, comparing to Billroth II anastomosis.
详细描述
Gastric cancer is still one of the most common malignant tumors, and gastric antrum cancer is still common. Radical surgery is the only way to treat gastric antrum cancer, surgical procedures and reconstruction are closely related with the prognosis and quality of life, the choice is crucial. Gastrojejunostomy after distal gastrectomy may affect the quality of radical surgery, and postoperative diet, nutritional status and quality of life. More and more centers tend to choose Billroth II anastomosis, but patients prone to have a variety of complications, including reflux gastritis and bile reflux, malnutrition, seriously affecting the quality of life and so on. According to preliminary pilot study found that, uncut Roux-en-Y anastomosis way can keep the continuity of nerve-muscle function of the reconstruction of digestive tract, and closes the input in order to reduce the incidence of reflux, for improving the nutritional status and reducing complications and improve quality of life. Therefore, the investigators intend to conduct multi-center randomized controlled study to find if Uncut Roux-en-Y anastomosis to the distal gastric cancer patients after radical D2 can reduce the long-term complications, affect the quality of life, and improve the prognosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathological diagnosed as the gastric carcinoma, the possibility of removal by the surgeon and imaging physician assessment.
- •no previous history of other malignancies combined.
- •patients have signed informed consent;
- •aged 18 to 80 years old, male or female patients;
- •cardiopulmonary, liver and kidney function was normal, ECOG physical status score of 0 to 1 (see Appendix);
- •the clinician determine the patient does not need emergency surgery;
排除标准
- •pregnant or lactating women;
- •the liver, lung, bone, and other distant metastasis;
- •supraclavicular lymph nodes, pelvic or ovarian species, peritoneal dissemination, etc;
- •a large number of ascites, cachexia;
- •suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, poorly controlled hypertension merger, diabetes patients;
- •or mental illness;
- •4 weeks prior to enrollment participated or are participating in other clinical trials of patients;
- •had undergone surgery, and its influence has not been eliminated in the patient;
- •of the stomach or esophagus history of malignancy, including stromal tumor, sarcoma, lymphoma, carcinoid;
- •patients with active infection (infection causing fever above 38 ℃);
- •patients with poor compliance or researchers consider poor patient compliance;
- •There are other clinical researchers believe that the laboratory the patient should not participate in the trial.
研究组 & 干预措施
uncut Roux-en-Y anastomosis
After distal gastrectomy, duodenal stump closure, side to side anastomosis was underwent on the remnant stomach and jejunum,which was 25cm from Treitz ligament. Then underwent side to side anastomosis between jejunum about 35cm distance from gastrojejunostomy and jejunum about 5cm from Triez ligament . close the intestinal cavity on the input less than 5cm distance from the loop gastrojejunostomy anastomosis by using uncut Closure devices
干预措施: Uncut Roux-en-Y anastomosis (Procedure)
Billroth II anastomosis
After distal gastrectomy, duodenal stump closure, the investigators first underwent remnant stomach and upper jejunum side anastomosis. Then choose the jejunum about 25cm from Treitz ligament, premenstrual colon using a disposable cutting closure (or tubular stapling) in the rear wall of the stomach and jejunum anastomosis, common opening was closed with the (barbed wire) hand-stitched. After that, steps were same with the group A.
干预措施: Billroth II anastomosis (Procedure)
结局指标
主要结局
Number of participants with treatment-related gastrointestinal and gastroesophageal reflux as assessed by The Los Angeles and Savary-Miller systems for grading esophagitis
时间窗: 0-5 years
次要结局
未报告次要终点