The Safety and Effect of Robot-assisted Procedure Versus Open Simultaneous Resection of Colorectal Cancer： Randomized Control Trial Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Surgical Complication
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of robot-assisted simultaneous resection in selected patients with sigmoid colon cancer or rectal cancer liver metastases, and compared with the traditional open procedure.
详细描述
The Da Vinci Surgical System may help to overcome some of the difficulties of laparoscopy for complicated abdominal surgery. The aim of this study was to present an innovative technique that is robot-assisted, simultaneous radical resection of both colorectal cancer and liver metastasis (RSRCLM).
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 75 years;
- •Primary tumor has undergone histologically confirmed colon adenocarcinoma; Colon cancer was defined by the presence of the inferior pole of the tumor above the peritoneal reflection (at least 15 cm from the anal margin).
- •Together with clinical or radiological evidence of Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2010 revision of the International Union Against Cancer primary tumor, regional nodes, metastasis (TNM) staging system);Liver metastasis was diagnosis by multidisciplinary (MDT) team base on liver Magnetic Resonance Imaging (MRI) and Positron Emission Computed Tomography (PET-CT).
- •Performance status (ECOG) 0~1
- •Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hemoglobin (Hb) ≥9g/dl (within 1 week prior to randomization)
- •Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either primary tumor, regional nodes, metastasis (AST) or ALT) ≤ 5 x ULN(within 1 week prior to randomization);
- •Written informed consent for participation in the trial.
- •The liver resectability was evaluated by liver surgery of MDT team, indication including: tumor number ≤ 3; the Maximum diameter of one tumor ≤ 10 cm.
排除标准
- •Body mass index (BMI) more than 30 kg/m
- •Serious pre-operative comorbidity, including cardiovascular disease (coronary arteriosclerosis, arrhythmia, heart failure), pulmonary dysfunction (lung emphysema, obstructive lung disease), liver insufficiency (Child-Pugh B or C), renal insufficiency (serum creatinine >2.0 mg/dl), and arterial circulation disturbance (occlusion of arterial vessels of limb in patient's history.
- •History of accepting abdominal surgery.
- •Liver tumor located at I or invasive the middle hepatic vein.
研究组 & 干预措施
RSRCLM
robot-assisted, simultaneous radical resection of both colorectal cancer and liver metastasis (RSRCLM).Three different liver resection procedures were chose to personalized patients. Generally, when the size of liver metastasis was ≤ 3 cm, a wedge resection was chose without Hilar vessels blocking. The segmentectomy was performed using the Glissonian approach when tumor size was among 3-5 cm, and Hilar vessels was blocked, if necessary. For resection of Couinaud's segments II and III, left lateral sectionectomy (LLS) was performed commonly. Intraoperative ultrasound can help us find intrahepatic pedicles and follow the proper resection line. When liver tumor size was more than 5 cm or more than 3 tumors with the size over 3cm, hemicolectomy was applied usually.
干预措施: RSRCLM (Procedure)
Open
Traditional open simultaneous radical resection of both colorectal cancer and liver metastasis. The DFS and safety event were evaluated.
干预措施: Open (Procedure)
结局指标
主要结局
Surgical Complication
时间窗: 30 days after surgury
According to Clavein-Dindo complication system to calculate the complication events during 30 day after surgery
次要结局
- Operative mortality(30 days post operatively)
- locoregional recurrence rate(3 and 5 years)
- Disease-free survival(DFS)(3 years disease-free survival)
- overall survival (OS)(OS rate at 3 and 5 years after operation)
研究者
Xu jianmin
Fudan University
Fudan University