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Minimally Invasive Liver Surgery for Metastases From Colorectal Cancer: Oncologic Outcome and Prognostic Factors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01356706
First Posted: May 19, 2011
Last Update Posted: July 3, 2012
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.
Information provided by (Responsible Party):
Baki Topal, University Hospital, Gasthuisberg
  Purpose
Only few reports exist on long-term survival after minimally invasive liver surgery (MILS for colorectal liver metastases. No data are available assessing prognostic factors in the era of current modern treatment strategies. The aim of the current study is to analyze the long-term oncologic outcome after MILS for metastases from colorectal cancer and determine prognostic indicators.

Condition
Long-term Oncologic Outcome of MILS in Patients With CRLM and Prognostic Indicators

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Baki Topal, University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • overall survival [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • prognostic variables [ Time Frame: 5 year ]

Biospecimen Retention:   Samples With DNA
Tissue samples for histopathology diagnosis & staging

Enrollment: 274
Study Start Date: October 2002
Study Completion Date: July 2012
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
CRLM
patients with colorectal liver metastases (CRLM) who undergo their primary surgery at UZ. Leuven (single-center academic study)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive patients sufering from colorectal liever metastases (CRLM) who undergo minimally invasive liver surgery (MILS) or open liver surgery (OLS)
Criteria

Inclusion Criteria:

  • Patients with CRLM
  • Surgery: resection and/or ablation
  • preoperative chemotherapy and/or biological agents are allowed
  • postoperative chemotherapy and/or biological agents are allowed
  • simultaneous colorectal resection is allowed

Exclusion Criteria:

  • primary liver cancer
  • benign liver tumors
  • pregnancy
  Contacts and Locations
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): NCT01356706


Locations
Belgium
University Hospitals Leuven KUL
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
  More Information

Responsible Party: Baki Topal, Professor of Surgery, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT01356706     History of Changes
Other Study ID Numbers: CRLM-MILS
First Submitted: May 17, 2011
First Posted: May 19, 2011
Last Update Posted: July 3, 2012
Last Verified: July 2012

Keywords provided by Baki Topal, University Hospital, Gasthuisberg:
liver metastases
colorectal cancer
surgery
prognosis