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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01356706
Other study ID # CRLM-MILS
Secondary ID
Status Completed
Phase N/A
First received May 17, 2011
Last updated July 1, 2012
Start date October 2002
Est. completion date July 2012

Study information

Verified date July 2012
Source University Hospital, Gasthuisberg
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 274
Est. completion date July 2012
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms

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

Locations

Country Name City State
Belgium University Hospitals Leuven KUL Leuven Vlaams-Brabant

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Gasthuisberg

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary overall survival 5 years No
Secondary prognostic variables 5 year No