We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

I Phase Surgery Versus Staged Surgery for Synchronous Liver Metastasis of Colorectal Cancer

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: NCT00677586
Recruitment Status : Completed
First Posted : May 14, 2008
Last Update Posted : March 25, 2009
Sponsor:
Information provided by:
Fudan University

Brief Summary:
The purpose of this study is to investigate the safety of simultaneous liver resections compared to staged hepatectomies of colorectal cancer with liver metastasis and to compare the long-term survival between the two groups.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Procedure: simultaneous resection of liver metastasis and the colorectal primary tumor Procedure: staged resection of liver metastasis and the colorectal primary tumor Phase 4

Detailed Description:
A consecutive patients of colorectal cancer with liver metastasis from ZhongShan hospital, Fudan university were enrolled and randomly assigned to simultaneous liver resections and staged hepatectomies. Post-operative complications, peri-operative mortality, long-term survival were compared.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2000
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
simultaneous resection of liver metastasis and the colorectal primary tumor
Procedure: simultaneous resection of liver metastasis and the colorectal primary tumor
simultaneous resection of liver metastasis and the colorectal primary tumor
Active Comparator: 2
staged resection of the liver metastasis and the colorectal primary tumor
Procedure: staged resection of liver metastasis and the colorectal primary tumor
Patients received resection of the colorectal tumor. 1 months later received resection of liver metastasis



Primary Outcome Measures :
  1. post-operative complication, peri-operative mortality [ Time Frame: 90 days after surgery ]

Secondary Outcome Measures :
  1. 5 years survival [ Time Frame: 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age <= 75 years
  • resectable primary colorectal tumor
  • remnant liver volume >= 70%
  • without other organ metastasis or peritoneum metastasis
  • without contradiction of cardiac and pulmonary diseases

Exclusion Criteria:

  • age > 75 years
  • unresectable primary colorectal tumor
  • remnant liver volume < 70%
  • with other organ metastasis or peritoneum metastasis
  • with contradiction of cardiac and pulmonary diseases

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): NCT00677586


Sponsors and Collaborators
Fudan University
Investigators
Study Director: jianmin xu, MD, PHD department of general surgery, zhongshan hospital, fudan university

Responsible Party: xu jianmin, zhongshan hospital, fudan university
ClinicalTrials.gov Identifier: NCT00677586     History of Changes
Other Study ID Numbers: 20080507
First Posted: May 14, 2008    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by Fudan University:
colorectal neoplasms
liver metastasis
surgery

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Extracts
Hematinics