The Science Behind DRAGON
Traditionally, liver surgery for cancerous or metastatic liver tumors and small FLRs relies on Portal Vein Embolization (PVE), a method used to induce hypertrophy (growth) of the healthy part of the liver. However, while effective, PVE alone can sometimes fall short in producing sufficient liver growth, particularly for patients with extensive liver disease. This is where DRAGON’s innovation comes in: by simultaneously embolizing both the portal vein and the hepatic vein on one side of the liver, PVE/HVE enhances and accelerates the hypertrophy process, producing a larger FLR in a shorter time. The technique, first described in humans by Guiu et al. in 2016, as Liver Venous Deprivation (LVD), has since evolved into a promising approach to expand surgical options for liver patients. This accelerated growth does potentially not only increases the pool of patients eligible for surgery but also significantly reduces the waiting time between the embolization and the eventual resection. Furthermore, by promoting a larger FLR, the procedure helps make the surgery safer, lowering the risk of Posthepatectomy Liver Failure (PHLF)—a serious complication that can arise when the remaining liver is too small to function properly after resection.
The DRAGON Trials: A Global Effort
DRAGON 1, the start of the project, has been successfully completed as a multicenter safety and training trial involving over 35 international centers. The primary goal was to ensure that each center could safely perform the combined PVE/HVE procedure and follow it with successful liver resection without a 90-day mortality due to complications. Each participating center recruited and treated at least three eligible patients, demonstrating the feasibility and safety of the procedure. The successful completion of DRAGON 1 laid the foundation for further trials and expanded the use of PVE/HVE globally.
DRAGON 2 is currently recruiting patients with colorectal cancer liver metastases (CRLM) and initiating centers globally. This large-scale, randomized controlled trial will enroll patients across multiple centers to rigorously compare the outcomes of combined PVE/HVE with traditional PVE alone. DRAGON 2 is focused on evaluating liver volume growth, surgical success, and long-term survival rates.
DRAGON PLC
In addition to these trials, DRAGON PLC is currently in preparation. This trial will focus on patients with primary liver cancer (PLC) and will explore the specific benefits of the PVE/HVE technique in enhancing liver regeneration for patients with hepatocellular carcinoma and cholangiocarcinoma. DRAGON PLC ensures that more patients worldwide will have access to this innovative and potentially life-saving treatment.
The DRAGON Registry
In addition to the clinical trials, the DRAGON Registry serves as a comprehensive international database, collecting valuable data from all patients undergoing PVE/HVE. This registry allows for continuous monitoring, research, and refinement of the procedure.