Minimally Invasive Versus Open Liver Resection for Patients With Colorectal Cancer Liver Metastases

March 27, 2019 updated by: Xu jianmin

Minimally Invasive(Laparoscopic and Robotic) Versus Open Liver Resection for Patients With Colorectal Cancer Liver Metastases

To examine survival of patients who underwent minimally invasive versus open liver resection for colorectal cancer with liver metastases.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

the minimally invasive procedure contain laparoscopic or robotic surgery

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Wenju Chang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Minimally Invasive surgery
the intevention of Minimally Invasive procedure contains laparoscopic and robotic liver resection
Procedure: laparoscopic and robotic liver resection
laparoscopic and robotic procedure for liver resection
OTHER: Open surgery
the open surgery means traditional open surgery for liver resection
Procedure: open surgery
using open surgery procedure for liver resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease-free survival (DFS)
Time Frame: 3 years disease-free survival
DFS was calculated from the date of liver resection to the date of death or recurrence or new tumors developing
3 years disease-free survival

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 5 years overall survival
OS was calculated from the date of liver resection to the date of death with any reason
5 years overall survival
Sugical complications
Time Frame: 1 months after sugery
According to Claivein-Dindo surgical complication system to calculate the perioperative complications related to surgery
1 months after sugery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xu jianmin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2019

Primary Completion (ANTICIPATED)

April 1, 2021

Study Completion (ANTICIPATED)

April 1, 2024

Study Registration Dates

First Submitted

June 28, 2017

First Submitted That Met QC Criteria

March 27, 2019

First Posted (ACTUAL)

March 29, 2019

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSRCLM-02

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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