Comparison of Anti-reflux Effects of Laparoscopic Proximal Gastrectomy With Double-flap Technique (Kamikawa Anastomosis) Versus Double-tract Reconstruction: A Prospective, Multicenter, Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 244
- 主要终点
- Proportion of patients with reflux esophagitis
研究概览
简要总结
This study is a multicenter, open-label, prospective, randomized parallel-controlled trial. The purpose is to explore whether the incidence rate of reflux esophagitis (RE) within 12 months after surgery is non-inferior for the DFT group compared to the DTR group.
详细描述
This study will enroll patients with proximal gastric cancer scheduled to undergo laparoscopic proximal gastrectomy. The patients will be randomly divided into two groups. One group will undergo laparoscopic proximal gastrectomy with double-flap technique (DFT) anastomosis, while the other group will undergo laparoscopic proximal gastrectomy with double-tract reconstruction (DTR). The primary endpoint is the proportion of patients who develop reflux esophagitis within 12 months after surgery. The secondary endpoints include postoperative complications, surgery-related indicators, and postoperative nutritional status.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 80 years, regardless of gender;
- •Patients diagnosed with gastric cancer through tissue biopsy;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- •American Society of Anesthesiologists (ASA) classification of I to III;
- •Acceptable for laparoscopic proximal gastrectomy with preoperative examinations (based on endoscopic ultrasound and/or contrast-enhanced computed tomography of the thorax and abdomen) confirming the following oncological features:
- •Primary tumor located in the upper part of the stomach (proximal 1/3 of the stomach) or gastroesophageal junction; Length of esophageal invasion ≤ 1 cm, tumor maximum diameter ≤ 4 cm; Preoperative staging T1-3N0M0 (based on AJCC 8th edition TNM clinical staging);
- •Voluntary signing of informed consent.
排除标准
- •Received preoperative chemotherapy, radiotherapy, targeted therapy, or immunotherapy;
- •Presence of contraindications to surgery;
- •Multiple malignant lesions in the stomach;
- •Presence of other malignancies that may affect the preservation of stomach function;
- •Previous upper abdominal surgery (excluding cholecystectomy);
- •Preoperative examination reveals active peptic ulcer;
- •Patients who have received or are currently receiving treatment for systemic inflammatory diseases;
- •Pregnant or breastfeeding women;
- •Conditions deemed unsuitable for participation in this study by the investigator.
结局指标
主要结局
Proportion of patients with reflux esophagitis
时间窗: Within 12 months after surgery
The percentage (%) of patients developing postoperative reflux esophagitis after surgery in the two group.
次要结局
- Postoperative complications(Within 12 months after surgery)
- Weight change(Within 12 months after surgery)
- Kamikawa anastomosis time(Perioperative period)
- intraoperative blood loss(Perioperative period)
- Operation time(Perioperative period)
- Ferritin value(Within 12 months after surgery)
- Albumin value(Within 12 months after surgery)
- Pre albumin value(Within 12 months after surgery)
- Folic acid value(Within 12 months after surgery)
- Vitamin B12 value(Within 12 months after surgery)
- Hemoglobin value(Within 12 months after surgery)
- Nutritional risk screening 2002(Within 12 months after surgery)
- Body Mass Index (BMI)(Within 12 months after surgery)