Long-term Oncologic Outcome of MILS in Patients With CRLM and Prognostic IndicatorsNCT01356706
Minimally Invasive Liver Surgery for Metastases From Colorectal Cancer: Oncologic Outcome and Prognostic Factors
An observational study of Long-term Oncologic Outcome of MILS in Patients With CRLM and Prognostic Indicators, run by University Hospital, Gasthuisberg at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Long-term Oncologic Outcome of MILS in Patients With CRLM and Prognostic Indicators
- How many people
- 274 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2002to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients sufering from colorectal liever metastases (CRLM) who undergo minimally invasive liver surgery (MILS) or open liver surgery (OLS)
Who may be able to join
- 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
Who cannot join
- primary liver cancer
- benign liver tumors
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Keywords
- liver metastases, colorectal cancer, surgery, prognosis
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CRLM | patients with colorectal liver metastases (CRLM) who undergo their primary surgery at UZ. Leuven (single-center academic study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 5 years
Secondary outcomes (1)
prognostic variables
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startOct 2002
- Primary completionDec 2008
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-term Oncologic Outcome of MILS in Patients With CRLM and Prognostic IndicatorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baki Topal, University Hospital, Gasthuisberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356706
- Sponsor's protocol ID
- CRLM-MILS
- Status last verified
- Jul 2012
- First submitted
- 17 May 2011
- Last updated
- 3 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Liver Surgery for Metastases From Colorectal Cancer: Oncologic Outcome and Prognostic Factors
- ClinicalTrials.gov ID
- NCT01356706
- Acronym / sponsor ID
- CRLM-MILS
- Keywords
- liver metastases, colorectal cancer, surgery, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Study start
- Oct 2002
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 19 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRLM | – | –patients with colorectal liver metastases (CRLM) who undergo their primary surgery at UZ. Leuven (single-center academic study) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients sufering from colorectal liever metastases (CRLM) who undergo minimally invasive liver surgery (MILS) or open liver surgery (OLS)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- primary liver cancer
- benign liver tumors
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall survival
Time frame: 5 years
1 secondary outcome
prognostic variables
Time frame: 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long-term Oncologic Outcome of MILS in Patients With CRLM and Prognostic Indicators, run by University Hospital, Gasthuisberg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2012.