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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Rafael
Diaz-Nieto
rafael.diaz-nieto@liverpoolft.nhs.uk
Prof
Ronald
Van Dam
r.van.dam@mumc.nl
Malignant neoplasms of digestive organsMalignant neoplasms of ill-defined, secondary and unspecified sites
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Liver resections of liver metastasis from a primary colorectal cancer can only be performed if there is a sufficient future liver remnant (FLR). This is commonly estimated by calculation of the total liver volume and the FLR volume. When preoperatively the estimated FLR is insufficient (traditionally < 30% of the total volume)some strategies are performed in order to promote liver hypertrophy/regeneration (increase of the volume of the FLR). The gold standard technique is portal vein embolization (PVE) that is the occlusion of the portal vein of one the sides of the liver that is planned to be resected (commonly the right or left sides of the liver). This allows an increased blood flow to the FLR and promotes its hypertrophy.
Based on the same principle, embolization of both portal vein and hepatic veins (PVE/HVE) on one side of the liver may be superior to PVE alone to enhance liver regeneration, but is a novel procedure and requires a safety and feasibility evaluation.
The current study, DRAGON 1, is designed to assess the ability of each participating centre to recruit 3 patients for the study without 90-day mortality due to complications (i.e. not due to primary tumour disease) within 12 months.
Once this study endpoint is met by one of the participating centres, this centre is offered to participate in the comparative randomized DRAGON 2 trial that will compare PVE vs. PVE/HVE.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Complex Intervention;
You can take part if:
You may not be able to take part if:
• Patients with extrahepatic disease other than lung metastases • Patients with metastatic disease to the lung that cannot be ablated or resected will be excluded • Patients with intrahepatic Cholangiocarcinoma (IHCC) • Patients with Perihilar Cholangiocarcinoma (PHCC) • Patients with Hepatocellular Carcinoma (HCC) • Pregnant or lactating women will not be eligible • Potential to get pregnant has to be excluded (obligatory contraception etc.) • Progression by modified RECIST criteria on cross-sectional imaging after conversion chemotherapy is an exclusion criterion. • Complete response in cross-sectional imaging after conversion chemotherapy, which is certainly a rare event
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by LIVERPOOL UNIVERSITY HOSPITALS NHS FOUNDATION TRUST and funded by Stichting Koningin Wilhelmina Fonds voor de Nederlandse Kankerbestrijding .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 45877
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