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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03895723
Recruitment Status : Unknown
Verified March 2019 by Xu jianmin, Fudan University.
Recruitment status was:  Recruiting
First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Xu jianmin, Fudan University

Study Description
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Brief Summary:
To examine survival of patients who underwent minimally invasive versus open liver resection for colorectal cancer with liver metastases.

Condition or disease Intervention/treatment Phase
Colorectal Liver Metastasis Procedure: laparoscopic and robotic liver resection Procedure: open surgery Not Applicable

Detailed Description:
the minimally invasive procedure contain laparoscopic or robotic surgery
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Arm A: minimally invasive surgery Arm B: open
Masking: Single (Outcomes Assessor)
Masking Description: The assessor was masking for patients treatment arms
Primary Purpose: Treatment
Official Title: Minimally Invasive(Laparoscopic and Robotic) Versus Open Liver Resection for Patients With Colorectal Cancer Liver Metastases
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2024
Arms and Interventions
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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
Open surgery
the open surgery means traditional open surgery for liver resection
 Procedure: open surgery
using open surgery procedure for liver resection


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Sugical complications [ Time Frame: 1 months after sugery ]
    According to Claivein-Dindo surgical complication system to calculate the perioperative complications related to surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03895723


Locations
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China, Shanghai
Wenju Chang Recruiting
Shanghai, Shanghai, China, 200032
Contact: Wenju Chang, MD    +8613764476150    chang_erich@hotmail.com   
Sponsors and Collaborators
Xu jianmin
More Information
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Responsible Party: Xu jianmin, Director of colorectal cancer center, Fudan University
ClinicalTrials.gov Identifier: NCT03895723    
Other Study ID Numbers: RSRCLM-02
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xu jianmin, Fudan University:
Colorectal liver metastasis
Minimally invasive surgery
Robotic surgery
Laparoscopic surgery
Additional relevant MeSH terms:
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Neoplasm Metastasis
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases