A 3-Arm Study Comparing the Efficacy of Anti-Reflux Alimentary Reconstruction Protocols (Single-Tract Jejunal Interposition vs Double Tract vs Tube-Like Stomach Reconstruction) After Laparoscopic Proximal Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Incidence of reflux esophagitis
研究概览
简要总结
The efficacy of three different alimentary reconstruction methods after proximal gastrectomy will be investigated in this study in a prospective, multicenter, randomized controlled trial.
详细描述
In the trial, 180 patients with early upper-third early gastric cancer and Siewert type II/III esophagogastric junction cancer will be enrolled and then randomly assigned to one of three groups: Group A (single-tract jejunal interposition n = 60), Group B (double-tract reconstruction, n = 60), or Group C (tube-like stomach reconstruction, n = 60). The primary co-end points were the incidence of reflux esophagitis at 2 years postoperatively. The secondary end points included the incidence of anastomotic leakage and anastomotic stenosis, operative time, intraoperative blood loss, quality of life, overall survival, and disease-free survival. Quality of life outcomes were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) 30-item core questionnaire (C30) and the EORTC QLQ stomach cancer-specific questionnaire at 3 months, 12 months, and 24 months.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-75 years old, male or female;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 (indicating fully active and able to continue all predisease activities without restriction) or 1 (indicating restricted in physically strenuous activities but ambulatory and able to perform work of a light or sedentary nature);
- •American Society of Anesthesiology physical status classification of I (indicating normal and healthy), II (indicating mild systemic disease), or III (indicating severe systemic disease);
- •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) (14) according to the eighth edition of the AJCC;
- •Patients without contraindications to surgery;
- •Voluntary participation by signing the written informed consent form approved by the institutional review board before study participation;
排除标准
- •Receipt of chemotherapy or radiotherapy for the treatment of GC before either surgical procedure
- •Combined resection required due to other diseases (except cholecystectomy).
- •History of cancer or concurrent cancer in other organs.
- •Previous or current receipt of treatment for systemic inflammatory disease or history of gastrectomy.
- •Patients with coagulation dysfunction which could not be corrected;
- •Vulnerable status (eg, lacking decision-making capacity, pregnant, or planning to become pregnant).
- •Receipt of chemotherapy or radiotherapy before either surgical procedure.
结局指标
主要结局
Incidence of reflux esophagitis
时间窗: At 1 year after LPG
次要结局
- Incidence of anastomotic leakage(At 1 year after LPG)
- Incidence of anastomotic stenosis(At 1 year after LPG)
- Intra-operative blood loss(Intraoperative)
- Operative time(Intraoperative)
- Overall survival, and disease-free survival(At 1 and 3 years after LPG)
研究者
Daorong Wang
M.D.
Northern Jiangsu People's Hospital