DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Combined PVE/HVE

Detailed Description: Resection of liver metastases from colorectal cancer (CRLM)

improves survival compared to chemotherapy alone and may lead to cure in up to 40% of

patients. Surgical resectability is limited by location of metastases and by FLR size and

function. Commonly, the volume of the future liver remnant (FLR) should be at least 30%

of the functional FLR volume. If this volume criterion is not met, the induction of liver

regeneration between a two-stage hepatectomy is performed at many centers, with the aim

to render patients resectable and reduce the risk of post hepatectomy liver failure. Gold

standard to induce regeneration is the embolization of the portal vein branches to the

tumor carrying liver (PVE) to induce regeneration of the FLR. Recently, combined

embolization of both portal and hepatic veins (PVE/HVE) has been described as an

alternative to portal vein embolization because it accelerates and increases growth of

the FLR. PVE/HVE combines simultaneous embolization of the portal main branches into the

tumor bearing liver and the hepatic vein draining them. The tissue in the part of the

liver treated with PVE/HVE stays viable because the hepatic artery continues to supplies

the liver deprived of portal and hepatic veins. Preclinical studies in pigs have

demonstrated feasibility of this method and human case series show accelerated and

increased liver growth. No multi-center evaluation has been performed so far. DRAGON 1 is

an international, prospective, multi-center trial to test enrolment capacity of

participants and safety of portal and hepatic vein embolization (PVE/HVE). DRAGON 1 will

form the basis of the RCT DRAGON 2 to compare PVE with PVE/HV. DRAGON 2 is expected to

start in 2021.