DRAGON 1
Research type
Research Study
Full title
DRAGON 1 - training, accreditation, implementation and safety evaluation of Portal and Hepatic Vein Embolization (PVE/HVE) to accelerate Future Liver Remnant (FLR) hypertrophy
IRAS ID
274587
Contact name
Rafael Diaz-Nieto
Contact email
Sponsor organisation
University of Maastricht
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Clinicaltrials.gov, NCT04272931
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
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.REC name
East Midlands - Derby Research Ethics Committee
REC reference
20/EM/0144
Date of REC Opinion
10 Jul 2020
REC opinion
Further Information Favourable Opinion