Introduction Patients with extensive colorectal liver metastases (CRLM) often require Future Liver
Remnant (FLR) hypertrophy-inducing procedures to minimize the risk of developing post-hepatectomy
liver failure. Combined Portal and Hepatic Vein Embolization (PVE/HVE) may accelerate
FLR hypertrophy and lead to higher resection rates. The aim of the DRAGON 1 trial
is to assess the training, implementation, feasibility, safety, and efficacy of PVE/HVE
in patients with primarily unresectable CRLM.
Methods The DRAGON 1 is a prospective, single-arm, international, multicenter trial. The
primary endpoint is the ability of each center to recruit 3 patients within 12 months,
without 90-day mortality due to complications related to the PVE/HVE procedure. Secondary
endpoints include resection rate, FLR-hypertrophy, complications, 90-day mortality
post-resection, recurrence and 1-year survival
Results A total of 102 patients from 43 centers across 14 countries were enrolled between
May 2020 and October 2022. 24 of the 43 centers were able to enroll 3 patients. No
procedure-related mortality was reported. There was one serious adverse event related
to the intervention. PVE/HVE resulted in a high kinetic growth rate and 90% of the
patients were resected.
Conclusions The DRAGON 1 trial demonstrates that PVE/HVE is safe and 56% of the participating
centers were able to recruit 3 patients. Additionally, a high kinetic growth rate
resulted in a resection rate of 90% after PVE/HVE.
