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

July 1, 2012 updated by: Baki Topal, University Hospital, Gasthuisberg
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

274

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

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • University Hospitals Leuven KUL

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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
CRLM
patients with colorectal liver metastases (CRLM) who undergo their primary surgery at UZ. Leuven (single-center academic study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
prognostic variables
Time Frame: 5 year
5 year

Collaborators and Investigators

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

Sponsor

University Hospital, Gasthuisberg

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

October 1, 2002

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

May 17, 2011

First Submitted That Met QC Criteria

May 17, 2011

First Posted (Estimate)

May 19, 2011

Study Record Updates

Last Update Posted (Estimate)

July 3, 2012

Last Update Submitted That Met QC Criteria

July 1, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CRLM-MILS

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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