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

This study has been completed.
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00677586
First received: May 12, 2008
Last updated: March 24, 2009
Last verified: March 2009
History of Changes
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • post-operative complication, peri-operative mortality [ Time Frame: 90 days after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 5 years survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: January 2000
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00677586

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

No publications provided

Responsible Party: xu jianmin, zhongshan hospital, fudan university
ClinicalTrials.gov Identifier: NCT00677586     History of Changes
Other Study ID Numbers: 20080507
Study First Received: May 12, 2008
Last Updated: March 24, 2009
Health Authority: China: Ministry of Health

Keywords provided by Fudan University:
colorectal neoplasms
liver metastasis
surgery

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

ClinicalTrials.gov processed this record on May 23, 2013