Clinical trial NCT02642978: Robot-assisted Procedure Versus Open Simultaneous Resection of Colorectal Cancer With Liver Metastases
Official title: The Safety and Effect of Robot-assisted Procedure Versus Open Simultaneous Resection of Colorectal Cancer： Randomized Control Trial Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Liver Metastasis
Keywords: minimally invasive surgery
colorectal liver metastasis
robotic surgery
Patients with resectable colorectal liver metastasis
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: micro-invasive surgery
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Surgical Complication
timeFrame: 30 days after surgury
Secondary outcomes:
measure: Operative mortality
timeFrame: 30 days post operatively
measure: Disease-free survival(DFS)
timeFrame: 3 years disease-free survival
measure: overall survival (OS)
timeFrame: OS rate at 3 and 5 years after operation
measure: locoregional recurrence rate
timeFrame: 3 and 5 years
Other outcomes:
measure: self reported bladder function
timeFrame: at postoperative 3, 6 and 1 2 months
measure: self reported sexual function for male patients
timeFrame: at postoperative 3, 6 and 1 2 month
measure: self reported sexual function for female patients
timeFrame: at postoperative 3, 6 and 1 2 months
measure: liver function
timeFrame: at Day 1，3，5 after surgery
Locations:
city: Shanghai
country: China
facility: Department of General Surgery, Zhongshan Hospital, Fudan University
Study officials:
affiliation: Fudan University
name: wenju chang, MD
role: PRINCIPAL_INVESTIGATOR
References: