A Prospective Colorectal Liver Metastasis Database With an Integrated Quality Assurance Program
- Conditions
- Liver MetastasisColorectal Carcinoma
- Interventions
- Other: Evaluation of treatment for liver metastasis
- Registration Number
- NCT02218801
- Brief Summary
This prospective database has two main objectives;
* to evaluate the complication rates, 30-day and 90-day mortality from different surgical strategies for unresectable, borderline resectable or initially unresectable liver metastasis from colorectal cancer.
* to establish baseline quality parameters for different surgical strategies for unresectable, borderline and initially unresectable colorectal liver metastasis (CRLM) patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 219
-
With histologically proven colorectal adenocarcinoma with liver metastasis.
-
With unresectable, borderline or initially unresectable liver metastasis from a colorectal cancer assessed by a clinician or by a multi-disciplinary tumor board (MDT).
- Unresectable is defined as no possibility of completely resecting all tumor due to size, location or number of deposits.
- Borderline is defined as potentially operable but technically or biologically more challenging to resect as evaluated by the MDT.
- Initially unresectable is defined as metastasis that have been down-sized after conversion chemotherapy and evaluated by the MDT to be resectable
-
discussed by a multidisciplinary team before surgery.
-
Participants of the MDT must include at least one liver surgeon, one radiologist and one oncologist. They will determine the resectability of the CRLM according to local practice.
-
With a possibility of a surgical procedure (resection with or without portal vein embolization, intraoperative local ablative technique or a combined approach) assessed during the MDT.
-
Age ≥ 18 years.
-
Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
- Any psychological, familial, or sociological condition potentially hampering understanding of the research project.
- Any other malignancy other than in situ carcinoma of the cervix or non-melanoma skin cancer (unless there has been a disease-free interval of at least 5 years)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Colorectal adenocarcinoma liver metastasis Evaluation of treatment for liver metastasis Unresectable, borderline or initially unresectable liver metastasis from a colorectal cancer
- Primary Outcome Measures
Name Time Method Number of post-operative complications 1 year
- Secondary Outcome Measures
Name Time Method Number of post-operative complications in the first 50 patients compared to the second 50 patients 1 year Overall survival after 2 years of follow-up 3 years Progression free survival at 2 years 3 years
Trial Locations
- Locations (16)
Innsbruck Universitaetsklinik
🇦🇹Innsbruck, Austria
Der Wiener Krankenanstaltenverbund - Krankenanstalt Rudolfstiftung
🇦🇹Vienna, Austria
Leiden University Medical Centre
🇳🇱Leiden, Netherlands
Oncology Institute of Vojvodina
🇷🇸Sremska Kamenica, Serbia
Institut Bergonie
🇫🇷Bordeaux, France
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Hôpitaux universitaires de Genève - HUG
🇨🇭Geneve, Switzerland
University Hosptial Gent
🇧🇪Gent, Belgium
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
🇳🇱Amsterdam, Netherlands
Centre Leon Berard
🇫🇷Lyon, France
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Universitaetsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Istituto Europeo di Oncologia
🇮🇹Milano, Italy
Hospital De Fuenlabrada
🇪🇸Fuenlabrada, Spain
Klinikum Der J.W. Goethe Universitaet
🇩🇪Frankfurt Am Main, Germany
Aintree University Hospital NHS Trust
🇬🇧Liverpool, United Kingdom