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

Colorectal Liver Metastasis Clinical Trial

Official title:

The Safety and Effect of Robot-assisted Procedure Versus Open Simultaneous Resection of Colorectal Cancer： Randomized Control Trial Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02642978
• Other study ID #: RSRCLM
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: September 1, 2019

Study information

• Verified date: March 2019
• Source: Fudan University
• Contact: jianmin Xu, MD
• Phone: 008613501984869
• Email: xujmin[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: September 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Liver Metastasis
• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Procedure:
• RSRCLM
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).
• Open
Traditional open simultaneous radical resection of both colorectal cancer and liver metastasis

Locations

Country	Name	City	State
China	Department of General Surgery, Zhongshan Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xu jianmin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	self reported bladder function	This section is assessed using a self-rating scale "International prostate symptom score" (IPSS)	at postoperative 3, 6 and 1 2 months
Other	self reported sexual function for male patients	This section is assessed using a self-rating scale "International Index of Erectile Function" (IIEF-5).	at postoperative 3, 6 and 1 2 month
Other	self reported sexual function for female patients	This section is assessed using a self-rating scale "Female Sexual Function Index" (FSFI).	at postoperative 3, 6 and 1 2 months
Other	liver function	Serum aminotransferase will be tested in the laboratory	at Day 1,3,5 after surgery
Primary	Surgical Complication	According to Clavein-Dindo complication system to calculate the complication events during 30 day after surgery	30 days after surgury
Secondary	Operative mortality	death occurred 30 days after operation	30 days post operatively
Secondary	Disease-free survival(DFS)	DFS was defined as from the date of randomization to the date of tumor	3 years disease-free survival
Secondary	overall survival (OS)	overall survival was defined as from the date of randomization to the date of Death ;	OS rate at 3 and 5 years after operation
Secondary	locoregional recurrence rate	local recurrence rate at 3 and 5 years after operation	3 and 5 years