Laparoscopic Proximal Gastrectomy with "C" Single Flap Plasty Reconstruction for Upper-Third Gastric Cancer: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- incidence of reflux esophagitis
研究概览
简要总结
The incidence of proximal gastric cancer has increased significantly in recent years. This may be due to weight gain, alcohol consumption, gastroesophageal reflux disease (GERD), and precancerous lesions. With a deeper understanding of the pattern of lymph node metastasis and the emergence of anti-reflux procedures, proximal gastrectomy has gradually received clinical attention. For early-stage upper gastric cancer and esophagogastric combination cancer cases that are expected to have a good prognosis, the ideal surgical procedure should be to preserve the distal stomach to improve the quality of life and to choose a reasonable digestive tract reconstruction method to prevent reflux. The anti-reflux effect of various proximal gastrectomy digestive tract reconstruction methods and the advantages and disadvantages of various surgical procedures are controversial, and the recognized ideal reconstruction method has not yet been established. Therefore, we propose a reconstruction called the "C" Single Flap Plasty Reconstruction. This study aimed to investigate the efficacy and safety of proximal gastrectomy combined with "C" Single Flap Plasty Reconstruction in the treatment of gastric cancer.
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
- Double (Care Provider, Outcomes Assessor)
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
- •Age between 18-80 years old, male or female;
- •Pathological diagnosis of preoperative endoscopic biopsy: the tumor is located in the upper 1/3 of the stomach (including the esophagogastric junction), and the clinical staging of gastric cancer： Ia and Ib (T1N0M0, T1N1M0, and T2N0M0) according to the eighth edition of the AJCC ;
- •No distant metastasis was observed on preoperative chest radiograph, abdominal ultrasound, or upper abdominal CT;
- •ASA grade 1-3;
- •Patients without contraindications to surgery;
- •Patients and their families voluntarily signed the informed consent form and participated in the study;
排除标准
- •Patients diagnosed with primary tumors or distant metastasis;
- •Patients whose tumor is located in the greater curvature side of the stomach;
- •Patients with coagulation dysfunction that could not be corrected;
- •Patients who were diagnosed with viral hepatitis and cirrhosis;
- •Patients who were diagnosed with diabetes mellitus, uncontrolled or controlled with insulin;
- •Patients with organ failure such as heart, lung, liver, brain, and kidney failure;
- •Patients with ascites or cachexia preoperatively in poor general conditions;
- •Patients diagnosed with immunodeficiency, immunosuppression, or autoimmune diseases (such as allogeneic bone marrow transplant, immunosuppressive drugs, SLE, etc.).
- •Patients refusing to sign the informed consent of the study;
结局指标
主要结局
incidence of reflux esophagitis
时间窗: 6 months after surgery
The percentage (%) of patients developing postoperative reflux esophagitis after surgery in each group.
次要结局
- incidence of anastomotic leakage(30 days after surgery)
研究者
Daorong Wang
PHD
Northern Jiangsu People's Hospital