Colorectal CancerNCT05036265
Prognostic Factors and Oncological Outcomes in Laparoscopic Liver Resection for CRLM
An observational study of Colorectal Cancer and Liver Metastases, run by General Hospital Groeninge.
Trial summary
Laparoscopic liver resection (LLR) has gained acceptance as an effective treatment for colorectal liver metastases (CRLM) in selected patients, providing similar oncologic outcomes compared to open liver resection (OLR). A single-center retrospective analysis of a prospectively maintained database was performed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer, Liver Metastases, Surgery
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2011to 5 Aug 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who received laparoscopic liver resection for colorectal liver metastases at General Hospital Groeninge between September 2011 and mid-March 2020
Who may be able to join
- Patients diagnosed with colorectal liver metastases
- Patients who received laparoscopic liver resection for colorectal liver metastases
- Patients who received the laparoscopic liver resection between September 2011 and mid-March 2020
Who cannot join
- Patients with contraindication for laparoscopic liver resection
- Refusal to participate in the study
About this study
Official title: Laparoscopic Liver Resection for Colorectal Liver Metastases: Retrospective Analysis of Prognostic Factors and Oncological Outcomes in a Single-center Cohort
Laparoscopic liver resection (LLR) has gained acceptance as an effective treatment for colorectal liver metastases (CRLM) in selected patients, providing similar oncologic outcomes compared to open liver resection (OLR). A single-center retrospective analysis of a prospectively maintained database was performed. The primary aim of this study was to determine prognostic factors for the survival outcomes associated with LLR for CRLM.
Read the detailed description
LLR was defined as pure LLR, including conversions to OLR. In case of missing data, additional details were retrieved from the individual patient file. Data on patient demographics, timing of diagnosis, neoadjuvant chemotherapy (NAC), tumor characteristics (both primary tumor and CRLM), histopathology, molecular characteristics, operative technique (including classification into anatomically major/technically major/minor LR), intra- and postoperative course, adjuvant chemotherapy (AC) as well as oncological outcomes (OS and DFS) were gathered and analyzed. Postoperative complications were graded according to the Clavien-Dindo classification. Complications were classified as major in case of Clavien-Dindo ≥ 3A.
- Conditions
- Colorectal Cancer, Liver Metastases, Surgery
- Keywords
- hepatopancreatobiliary, laparoscopic liver resection, colorectal liver metastasis
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival outcomes
Overall and disease-free survival (Kaplan-Meier method)
Measured: 9 years
Prognostic factors
Univariate Cox proportional-hazards regression analysis
Measured: 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Sep 2011
- Primary completion15 Mar 2020
- Study completion5 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital Groeninge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. M. D'hondt, General Hospital Groeninge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036265
- Sponsor's protocol ID
- B396201939301
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Liver Resection for Colorectal Liver Metastases: Retrospective Analysis of Prognostic Factors and Oncological Outcomes in a Single-center Cohort
- ClinicalTrials.gov ID
- NCT05036265
- Acronym / sponsor ID
- B396201939301
- Conditions
- Colorectal Cancer, Liver Metastases, Surgery
- Keywords
- hepatopancreatobiliary, laparoscopic liver resection, colorectal liver metastasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- General Hospital GroeningeUniversity, hospital or other
- Study start
- 1 Sep 2011 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 5 Aug 2021 (actual)
- First posted
- 5 Sep 2021 (actual)
- 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.
Laparoscopic liver resection (LLR) has gained acceptance as an effective treatment for colorectal liver metastases (CRLM) in selected patients, providing similar oncologic outcomes compared to open liver resection (OLR). A single-center retrospective analysis of a prospectively maintained database was performed. The primary aim of this study was to determine prognostic factors for the survival outcomes associated with LLR for CRLM.
Detailed description
LLR was defined as pure LLR, including conversions to OLR. In case of missing data, additional details were retrieved from the individual patient file. Data on patient demographics, timing of diagnosis, neoadjuvant chemotherapy (NAC), tumor characteristics (both primary tumor and CRLM), histopathology, molecular characteristics, operative technique (including classification into anatomically major/technically major/minor LR), intra- and postoperative course, adjuvant chemotherapy (AC) as well as oncological outcomes (OS and DFS) were gathered and analyzed. Postoperative complications were graded according to the Clavien-Dindo classification. Complications were classified as major in case of Clavien-Dindo ≥ 3A.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who received laparoscopic liver resection for colorectal liver metastases at General Hospital Groeninge between September 2011 and mid-March 2020
Key inclusion criteria (3 listed)
- Patients diagnosed with colorectal liver metastases
- Patients who received laparoscopic liver resection for colorectal liver metastases
- Patients who received the laparoscopic liver resection between September 2011 and mid-March 2020
Key exclusion criteria (2 listed)
- Patients with contraindication for laparoscopic liver resection
- Refusal to participate in the study
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
Survival outcomes
Time frame: 9 years
Overall and disease-free survival (Kaplan-Meier method)
Prognostic factors
Time frame: 9 years
Univariate Cox proportional-hazards regression analysis
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 5 Sep 2021.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Liver Metastases, run by General Hospital Groeninge.
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 3 inclusion and 2 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 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Survival outcomes (time frame: 9 years). The study lists 2 primary outcomes in all. 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 5 Sep 2021.