A Prospective Study on the Perioperative Safety and Short-Term Quality of Life in Totally Laparoscopic Proximal Gastrectomy With Esophagogastrostomy by Fissure Technique
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assess intraoperative Perioperative Safety by Duration of surgery.
研究概览
简要总结
This is a single-center, open-label, Phase Ib/II study aiming to assess the perioperative safety and postoperative outcomes of a novel surgical technique in treating primary adenocarcinoma located in the upper 1/3 of the stomach or gastroesophageal junction (Siewert II or III).
The study will enroll 30 patients who will undergo totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique. Clinical data will be collected to evaluate perioperative safety. Patients will be followed for at least 3 months, during which endoscopy will be performed to analyze occurrences and reasons for anastomotic-related complications. Additionally, the quality of life after surgery will be evaluated by QLQ-C30 and QLQ-STO22.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 and 75 years old;
- •Pathologically confirmed as adenocarcinoma;
- •Primary tumor located in the upper 1/3 of the stomach or the gastroesophageal junction (Siewert II or III);
- •If it is adenocarcinoma of the upper 1/3 of the stomach, cT1N0M0 should be met.
- •For gastroesophageal junction adenocarcinoma, cT1-2N0M0 should be met, and clinical judgment should indicate no distant lymph node metastasis around the stomach.
- •Bilateral resection margins should be greater than 2 cm, and more than half of the residual stomach should be preserved.
- •No history of upper abdominal surgery (excluding laparoscopic cholecystectomy).
- •No preoperative comprehensive treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.
- •Preoperative ECOG (Eastern Cooperative Oncology Group) score of 0/
- •Preoperative ASA (American Society of Anesthesiologists) score I-III.
- •Good function of important organs.
- •Signed informed consent.
排除标准
- •Preoperative assessment indicating cT4b or Bulky lymph nodes enlargement or distant lymph nodes metastasis;
- •Pregnant or lactating women;
- •Patients with severe mental illness;
- •Preoperative temperature ≥38°C or infectious diseases requiring systemic treatment;
- •Severe respiratory diseases, with FEV1 < 50% of predicted value;
- •History of other malignant tumors in the past 5 years;
- •Severe liver or kidney dysfunction;
- •Unstable angina or myocardial infarction within the last 6 months;
- •History of stroke or cerebral hemorrhage within the last 6 months (excluding old infarcts);
- •Systemic use of glucocorticoids within the last 1 month;
- •Emergency surgery required due to complications of gastric cancer (bleeding, perforation, obstruction);
- •Patient has participated in or is currently participating in other clinical trials (within the last 6 months).
研究组 & 干预措施
Experimental group
Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique
干预措施: Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique (Procedure)
结局指标
主要结局
Assess intraoperative Perioperative Safety by Duration of surgery.
时间窗: intraoperative
Time spent on the whole operation（minutes）
Assess intraoperative Perioperative Safety by blood loss .
时间窗: intraoperative
Intraoperative blood loss in milliliters
Postoperative TNM staging by Pathological findings .
时间窗: 30 days after the surgery
AJCC（American Joint Committee on Cancer）-8th TNM staging system will be used to obtain pathology of tumor .
Postoperative recovery course
时间窗: 30 days after the surgery
Time to remove the drain tube,flatus, to liquid diet, and soft diet are used to assess the postoperative recovery course, which is a composite outcome measure.
Assess intraoperative Perioperative Safety by Duration of anastomosis.
时间窗: intraoperative
Time spent on the anastomosis in minutes
次要结局
- Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-C30(3 months after surgery)
- The incidence of postoperative reflux esophagitis(3 months after surgery)
- The incidence of postoperative anastomotic stenosis(3 months after surgery)
- Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-STO22 scale(3 months after surgery)