- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05036265
Prognostic Factors and Oncological Outcomes in Laparoscopic Liver Resection for CRLM
August 30, 2021 updated by: Dr. M. D'hondt, General Hospital Groeninge
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
200
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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients who received laparoscopic liver resection for colorectal liver metastases at General Hospital Groeninge between September 2011 and mid-March 2020
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with contraindication for laparoscopic liver resection
- Refusal to participate in the study
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survival outcomes
Time Frame: 9 years
|
Overall and disease-free survival (Kaplan-Meier method)
|
9 years
|
|
Prognostic factors
Time Frame: 9 years
|
Univariate Cox proportional-hazards regression analysis
|
9 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ACTUAL)
September 1, 2011
Primary Completion (ACTUAL)
March 15, 2020
Study Completion (ACTUAL)
August 5, 2021
Study Registration Dates
First Submitted
August 23, 2021
First Submitted That Met QC Criteria
August 30, 2021
First Posted (ACTUAL)
September 5, 2021
Study Record Updates
Last Update Posted (ACTUAL)
September 5, 2021
Last Update Submitted That Met QC Criteria
August 30, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B396201939301
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.