Back to resultsMinimally Invasive Versus Open Liver Resection for Patients With Colorectal Cancer Liver Metastases
Primary Purpose
Colorectal Liver Metastasis
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
laparoscopic and robotic liver resection
open surgery
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Liver Metastasis focused on measuring Colorectal liver metastasis, Minimally invasive surgery, Robotic surgery, Laparoscopic surgery
Eligibility Criteria
Inclusion Criteria:
- patients were diagnosed with colorectal cancer liver metastases
- without extra-hepatic liver metastases
- age were within 18-75 yeas
- the numbers of metastases more than 3
- the maximal tumor size of liver metastases more than 10 cm
Exclusion Criteria:
- liver metastases were unresectable.
Sites / Locations
- Wenju ChangRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Minimally Invasive surgery
Open surgery
Arm Description
the intevention of Minimally Invasive procedure contains laparoscopic and robotic liver resection
the open surgery means traditional open surgery for liver resection
Outcomes
Primary Outcome Measures
disease-free survival (DFS)
DFS was calculated from the date of liver resection to the date of death or recurrence or new tumors developing
Secondary Outcome Measures
Overall survival (OS)
OS was calculated from the date of liver resection to the date of death with any reason
Sugical complications
According to Claivein-Dindo surgical complication system to calculate the perioperative complications related to surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03895723
Brief Title
Minimally Invasive Versus Open Liver Resection for Patients With Colorectal Cancer Liver Metastases
Official Title
Minimally Invasive(Laparoscopic and Robotic) Versus Open Liver Resection for Patients With Colorectal Cancer Liver Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
April 1, 2021 (Anticipated)
Study Completion Date
April 1, 2024 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To examine survival of patients who underwent minimally invasive versus open liver resection for colorectal cancer with liver metastases.
Detailed Description
the minimally invasive procedure contain laparoscopic or robotic surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Liver Metastasis
Keywords
Colorectal liver metastasis, Minimally invasive surgery, Robotic surgery, Laparoscopic surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Arm A: minimally invasive surgery Arm B: open
Masking
Outcomes Assessor
Masking Description
The assessor was masking for patients treatment arms
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Minimally Invasive surgery
Arm Type
Experimental
Arm Description
the intevention of Minimally Invasive procedure contains laparoscopic and robotic liver resection
Arm Title
Open surgery
Arm Type
Other
Arm Description
the open surgery means traditional open surgery for liver resection
Intervention Type
Procedure
Intervention Name(s)
laparoscopic and robotic liver resection
Intervention Description
laparoscopic and robotic procedure for liver resection
Intervention Type
Procedure
Intervention Name(s)
open surgery
Intervention Description
using open surgery procedure for liver resection
Primary Outcome Measure Information:
Title
disease-free survival (DFS)
Description
DFS was calculated from the date of liver resection to the date of death or recurrence or new tumors developing
Time Frame
3 years disease-free survival
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
OS was calculated from the date of liver resection to the date of death with any reason
Time Frame
5 years overall survival
Title
Sugical complications
Description
According to Claivein-Dindo surgical complication system to calculate the perioperative complications related to surgery
Time Frame
1 months after sugery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients were diagnosed with colorectal cancer liver metastases
without extra-hepatic liver metastases
age were within 18-75 yeas
the numbers of metastases more than 3
the maximal tumor size of liver metastases more than 10 cm
Exclusion Criteria:
liver metastases were unresectable.
Facility Information:
Facility Name
Wenju Chang
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenju Chang, MD
Phone
+8613764476150
Email
chang_erich@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Minimally Invasive Versus Open Liver Resection for Patients With Colorectal Cancer Liver Metastases
We'll reach out to this number within 24 hrs