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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baki Topal, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT01356706
First received: May 17, 2011
Last updated: July 1, 2012
Last verified: July 2012
  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

Resource links provided by NLM:


Further study details as provided by University Hospital, Gasthuisberg:

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

Secondary Outcome Measures:
  • prognostic variables [ Time Frame: 5 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01356706

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

No publications provided

Responsible Party: Baki Topal, Professor of Surgery, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT01356706     History of Changes
Other Study ID Numbers: CRLM-MILS
Study First Received: May 17, 2011
Last Updated: July 1, 2012
Health Authority: Belgium: Ethics Committee

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

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

ClinicalTrials.gov processed this record on April 23, 2014