Colorectal Liver Metastasis
Conditions
Keywords
minimally invasive surgery, colorectal liver metastasis, robotic surgery, Patients with resectable colorectal liver metastasis
Brief summary
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.
Detailed description
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).
Interventions
PROCEDURERSRCLM
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).
PROCEDUREOpen
Traditional open simultaneous radical resection of both colorectal cancer and liver metastasis
Sponsors
Xu jianmin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
micro-invasive surgery
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 and ≤ 75 years; 2. 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). 3. 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). 4. Performance status (ECOG) 0\ 1 5. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hemoglobin (Hb) ≥9g/dl (within 1 week prior to randomization) 6. 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); 7. Written informed consent for participation in the trial. 8. The liver resectability was evaluated by liver surgery of MDT team, indication including: tumor number ≤ 3; the Maximum diameter of one tumor ≤ 10 cm.
Exclusion criteria
1. Body mass index (BMI) more than 30 kg/m2. 2. 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. 3. History of accepting abdominal surgery. 4. Liver tumor located at I or invasive the middle hepatic vein.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Complication | 30 days after surgury | According to Clavein-Dindo complication system to calculate the complication events during 30 day after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative mortality | 30 days post operatively | death occurred 30 days after operation |
| Disease-free survival(DFS) | 3 years disease-free survival | DFS was defined as from the date of randomization to the date of tumor |
| overall survival (OS) | OS rate at 3 and 5 years after operation | overall survival was defined as from the date of randomization to the date of Death ; |
| locoregional recurrence rate | 3 and 5 years | local recurrence rate at 3 and 5 years after operation |
Other
| Measure | Time frame | Description |
|---|---|---|
| self reported sexual function for male patients | at postoperative 3, 6 and 1 2 month | This section is assessed using a self-rating scale International Index of Erectile Function (IIEF-5). |
| self reported sexual function for female patients | at postoperative 3, 6 and 1 2 months | This section is assessed using a self-rating scale Female Sexual Function Index (FSFI). |
| liver function | at Day 1，3，5 after surgery | Serum aminotransferase will be tested in the laboratory |
| self reported bladder function | at postoperative 3, 6 and 1 2 months | This section is assessed using a self-rating scale International prostate symptom score (IPSS) |
Countries
China
Contacts
Primary Contactjianmin Xu, MD
Outcome results
None listed