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

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Liver Metastasis
• Intervention / Treatment: Procedure: RSRCLM; Procedure: Open

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: jianmin xu, MD; Phone Number: 008613501984869; Email: xujmin@aliyun.com

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • Department of General Surgery, Zhongshan Hospital, Fudan University
    • Contact: jianmin xu, professor; Phone Number: 008613501984869; Email: xujmin@yahoo.com.cn
    • Contact: yunshi zhong, doctor; Phone Number: 008613564623481; Email: zhong780124@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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).
Active Comparator: Open; Traditional open simultaneous radical resection of both colorectal cancer and liver metastasis. The DFS and safety event were evaluated.	Procedure: Open; Traditional open simultaneous radical resection of both colorectal cancer and liver metastasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Complication	According to Clavein-Dindo complication system to calculate the complication events during 30 day after surgery	30 days after surgury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative mortality	death occurred 30 days after operation	30 days post operatively
Disease-free survival(DFS)	DFS was defined as from the date of randomization to the date of tumor	3 years disease-free survival
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
locoregional recurrence rate	local recurrence rate at 3 and 5 years after operation	3 and 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
liver function	Serum aminotransferase will be tested in the laboratory	at Day 1，3，5 after surgery

Collaborators and Investigators

• Sponsor: Xu jianmin
• Investigators: Principal Investigator: wenju chang, MD, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: September 8, 2015
• First Submitted That Met QC Criteria: December 28, 2015
• First Posted (Estimate): December 30, 2015

Study Record Updates

• Last Update Posted (Actual): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: minimally invasive surgery; robotic surgery; colorectal liver metastasis; Patients with resectable colorectal liver metastasis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Neoplastic Processes; Neoplasm Metastasis; Liver Neoplasms
• Other Study ID Numbers: RSRCLM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No