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

Primary Purpose

Colorectal Liver Metastasis

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

RSRCLM

Open

About this trial

This is an interventional treatment trial for Colorectal Liver Metastasis focused on measuring minimally invasive surgery, colorectal liver metastasis, robotic surgery, Patients with resectable colorectal liver metastasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 and ≤ 75 years;
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).
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).
Performance status (ECOG) 0~1
Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hemoglobin (Hb) ≥9g/dl (within 1 week prior to randomization)
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);
Written informed consent for participation in the trial.
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:

Body mass index (BMI) more than 30 kg/m2.
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.
History of accepting abdominal surgery.
Liver tumor located at I or invasive the middle hepatic vein.

Sites / Locations

Department of General Surgery, Zhongshan Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RSRCLM

Open

Arm Description

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.

Traditional open simultaneous radical resection of both colorectal cancer and liver metastasis. The DFS and safety event were evaluated.

Outcomes

Primary Outcome Measures

Surgical Complication

According to Clavein-Dindo complication system to calculate the complication events during 30 day after surgery

Secondary Outcome Measures

Operative mortality

death occurred 30 days after operation

Disease-free survival(DFS)

DFS was defined as from the date of randomization to the date of tumor

overall survival (OS)

overall survival was defined as from the date of randomization to the date of Death ;

locoregional recurrence rate

local recurrence rate at 3 and 5 years after operation

Full Information

NCT ID

NCT02642978

First Posted

September 8, 2015

Last Updated

March 27, 2019

Sponsor

Xu jianmin

1. Study Identification

Unique Protocol Identification Number

NCT02642978

Brief Title

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

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2015 (Actual)

Primary Completion Date

April 1, 2019 (Anticipated)

Study Completion Date

September 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Xu jianmin

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Liver Metastasis

Keywords

minimally invasive surgery, colorectal liver metastasis, robotic surgery, Patients with resectable colorectal liver metastasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

micro-invasive surgery

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RSRCLM

Arm Type

Experimental

Arm Description

Arm Title

Open

Arm Type

Active Comparator

Arm Description

Traditional open simultaneous radical resection of both colorectal cancer and liver metastasis. The DFS and safety event were evaluated.

Intervention Type

Procedure

Intervention Name(s)

RSRCLM

Intervention Description

Intervention Type

Procedure

Intervention Name(s)

Open

Intervention Description

Traditional open simultaneous radical resection of both colorectal cancer and liver metastasis

Primary Outcome Measure Information:

Title

Surgical Complication

Description

According to Clavein-Dindo complication system to calculate the complication events during 30 day after surgery

Time Frame

30 days after surgury

Secondary Outcome Measure Information:

Title

Operative mortality

Description

death occurred 30 days after operation

Time Frame

30 days post operatively

Title

Disease-free survival(DFS)

Description

DFS was defined as from the date of randomization to the date of tumor

Time Frame

3 years disease-free survival

Title

overall survival (OS)

Description

overall survival was defined as from the date of randomization to the date of Death ;

Time Frame

OS rate at 3 and 5 years after operation

Title

locoregional recurrence rate

Description

local recurrence rate at 3 and 5 years after operation

Time Frame

3 and 5 years

Other Pre-specified Outcome Measures:

Title

self reported bladder function

Description

This section is assessed using a self-rating scale "International prostate symptom score" (IPSS)

Time Frame

at postoperative 3, 6 and 1 2 months

Title

self reported sexual function for male patients

Description

This section is assessed using a self-rating scale "International Index of Erectile Function" (IIEF-5).

Time Frame

at postoperative 3, 6 and 1 2 month

Title

self reported sexual function for female patients

Description

This section is assessed using a self-rating scale "Female Sexual Function Index" (FSFI).

Time Frame

at postoperative 3, 6 and 1 2 months

Title

liver function

Description

Serum aminotransferase will be tested in the laboratory

Time Frame

at Day 1，3，5 after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 and ≤ 75 years; 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). 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). Performance status (ECOG) 0~1 Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hemoglobin (Hb) ≥9g/dl (within 1 week prior to randomization) 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); Written informed consent for participation in the trial. 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: Body mass index (BMI) more than 30 kg/m2. 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. History of accepting abdominal surgery. Liver tumor located at I or invasive the middle hepatic vein.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

jianmin Xu, MD

Phone

008613501984869

xujmin@aliyun.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

wenju chang, MD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of General Surgery, Zhongshan Hospital, Fudan University

City

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

jianmin xu, professor

Phone

008613501984869

xujmin@yahoo.com.cn

First Name & Middle Initial & Last Name & Degree

yunshi zhong, doctor

Phone

008613564623481

zhong780124@sina.com

12. IPD Sharing Statement

Plan to Share IPD

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

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