A Prospective Colorectal Liver Metastasis Database With an Integrated Quality Assurance Program

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2015

End Date

February 2021

Last Updated

3 years ago

Study Type

Observational

Sex

All

Sponsor

Responsible Party

Sponsor

•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)

Number of post-operative complications

Time Frame: 1 year

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)