Preoperative CTA to Evaluate the Influence of Gastric Artery Type on the Clinical Outcome of Gastric Cancer Patients With BMI≥25.0 kg/m2：A Multicenter Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 382
- 试验地点
- 1
- 主要终点
- Intraoperative blood loss
研究概览
简要总结
Gastric cancer is one of the most common malignace worldwide, which caused a dramatically death rate, especially in east Asian, such as Japan , South Korea and China. Although the treatment of gastric cancer has a large improvement, such as radiotherapy, chemotherapy and immunotherapy, surgery is yet the mainstream method for the curable malignace without distant metastasis. As the innovation of treatment in gastric caner, laprascopic has gain its popularity owing to its equivalent oncologic outcomes, earlier oral feeding, shorten postopertative of hospital length,compared with open surgery. Depite it has several advantages, the defect of laparascopic surgery is still obvious, such as 2D surgical field, lack of inverse haptic feedback, Inflexible equipment.
D2 Lymph node dissection associated with laparascopic gastronomy is still regard as standard surgical procedure for the gastric cancer patient whose tumor stage was evaluated in advance stage. As we known that the distribution of lymph nod is accompanied with blood vessels, even for well-trained surgeon, the procedure lymph node dissection is a challenging and tough work. Computed Tomography Angiography(3D-CTA), as a emerging technology, is gradually receive the surgeon's attention for its remedy characteristic to the defect of laparascopic surgery, which can visually display the distribution and type of perigastric artery, resulting in decresing the difficulty and risk of surgery.
The aim of the study is to investigate the clinincal outcomes for the patient with BMI ≥25 kg/㎡who underwent laparascopic or robotic gastronomy using CTA to evaluate the type of perigastric artery.
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 (Outcomes Assessor)
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
- •Pathological diagnosis of gastric adenocarcinoma by gastroscopy
- •Age 18~75 years old
- •BMI≥25.0kg/m2
- •Preoperative imaging staging is T1~T4a, N0~3, M0
- •The surgical approach is laparoscopic surgery and robotic surgery
排除标准
- •Patients whose tumors stage are found to be T4b or M1 during the operation, tumors are unresectable and accompanied with malignant tumors in other parts;
- •suffering from other malignant tumors, tumors of low malignant potential (giant cell tumor of bone, pseudomyxadenoma of appendix, invasive fibroma) in the past;
- •Patients who have serious other system diseases and cannot tolerate surgery;
- •Patients with non-adenocarcinoma type malignant tumors in pathology after surgery;
- •Patients with residual gastric cancer;
- •Those who are allergic to iodine contrast agents;
- •Those who have received neoadjuvant therapy before surgery;
- •Pregnant patients;
- •Patients who are participating in other clinical studies trial.
结局指标
主要结局
Intraoperative blood loss
时间窗: during the surgery
haemorrhagia amount during the operation
次要结局
- hospitalization costs length of hospitalization days(during the hospitalization)
- Number of lymph node dissection guided by vessel(during the surgery)
- Postoperative recovery course(30 days)
- The total incidence of postoperative complications(30 days)
- 30-day mortality(30 days)
- 3 years DFS(3 years)
- 3 years OS(3 years)