DRAGON 2
Research type
Research Study
Full title
DRAGON 2 – An international multicenter randomized controlled trial to compare combined Portal and Hepatic Vein Embolization (PVE/HVE) with PVE alone.
IRAS ID
327250
Contact name
Rafael Diaz Nieto
Contact email
Sponsor organisation
University Of Maastricht
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 3 months, 31 days
Research summary
Resection of liver metastases from colorectal cancer (CRLM) improves survival compared to chemotherapy alone and may lead to cure. In some cases the liver metastasis are considered unresectable. A common reason for this is the lack of enough "tumour free" liver for the patient to survive the operation (Future liver remnant -FLR-). In the event of insufficient FLR, there is a great proportion of patients that will develop liver disfunction that can lead to death (post-hepatectomy liver failure is the main reason for postoperative mortality after liver resection). Extended liver resections are sometimes necessary to resect primarily unresectable/ potentially resectable (PU/PR) colorectal liver metastases.
These resections can only be performed if the volume of the future liver remnant (FLR) comprises at least 30-40% of the total volume of the liver (without the volume of the metastases). When FLR is less than 30% there are some interventions that promote liver regeneration and increase FLR. The current standard procedure to induce regeneration is the embolization (blockage) of the portal vein branches to the tumor carrying liver (PVE) to induce hypertrophy of the remaining part of the liver which will serve as the FRL. Recently, combined embolization of both portal and hepatic veins (PVE/HVE) has been described as a possible superior alternative to PVE, as it increases and accelerates hypertrophy of the FLR. PVE/HVE combines simultaneous embolization of the main portal vein branches into the tumour carrying liver and the hepatic vein draining this part of the liver. Preclinical studies in pigs, several retrospective studies, and the prospective DRAGON 1 interim analysis have demonstrated the safety and feasibility of this novel technique. However, no international randomized controlled trial has been performed, in which combined PVE/HVE is compared with PVE alone.REC name
East of England - Essex Research Ethics Committee
REC reference
23/EE/0269
Date of REC Opinion
18 Jan 2024
REC opinion
Further Information Favourable Opinion