Robot-assisted Procedure Versus Open Simultaneous Resection of Colorectal Cancer With Liver Metastases

Not Applicable

• Conditions: Colorectal Liver Metastasis

• Registration Number: NCT02642978
• Lead Sponsor: Xu jianmin

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).

Study Timeline

• Study Start: 2015-09-01
• Study First Submitted: 2015-09-08
• Study First Submitted QC: 2015-12-28
• Study First Posted: 2015-12-30
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-29
• Primary Completion: 2019-04-01
• Study Completion: 2019-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Surgical Complication	30 days after surgury	According to Clavein-Dindo complication system to calculate the complication events during 30 day after surgery

Secondary Outcome Measures

Name	Time	Method
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 ;
Operative mortality	30 days post operatively	death occurred 30 days after operation
locoregional recurrence rate	3 and 5 years	local recurrence rate at 3 and 5 years 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

Trial Locations

Locations (1)

Department of General Surgery, Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, China