The DRAGON PLC Trial - An International Multicenter Randomized Controlled Trial to Compare Combined Portal and Hepatic Vein Embolization (PVE/HVE) With PVE Alone in Primary Liver Cancers.
Maastricht University
Summary
The goal of the DRAGON PLC clinical trial is to determine whether portal vein embolization (PVE) combined with hepatic vein embolization (HVE) improves resectability and overall survival in patients with initially unresectable primary liver cancer compared to standard PVE alone. This trial specifically focuses on patients with hepatocellular carcinoma and cholangiocarcinoma. The main questions this trial aims to answer are whether combined PVE and HVE increases the proportion of patients who become resectable within 3 weeks and improves 5-year overall survival compared to PVE alone by enhancing liver hypertrophy. Participants will: * Undergo either standard PVE or combined PVE and HVE. * Have regular imaging to assess liver resectability. * Be monitored for survival outcomes up to 5 years after intervention.
Description
Primary liver cancer (PLC) is the third most common cause of cancer death worldwide. Surgical resection is the mainstay for a curative approach as contemporary chemotherapy and immune-based therapies only lead to a median survival of 10-14 months. A complete surgical resection increases the median survival to 42 months (range 32-52 months). However, PLC is mainly diagnosed at an advanced stage and \>70% of PLC patients are ineligible for an immediate surgical approach. There are different reasons that make a patient ineligible for surgery, one important reason is the risk of liver failure afte…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * PLC diagnosis, specifically iCCC, pCCC, and HCC; * Requiring PVE due to an FLR volume is \<30% in normally functioning livers, \<40% in livers with potentially impaired function e.g. resulting from prior systemic therapy induction or bile duct colonization / transpapillary biliary drainage, or \<50% in livers with severely impaired function resulting from liver cirrhosis (max. Child Pugh A5) OR function on hepatobiliary scintigraphy (HEBIS) is \< 2.7 %/min/m2; * Age ≥ 18 years; * Able to understand the trial and provide informed consent. Exclusion Criteria: * Liver cir…
Interventions
- ProcedurePortal Vein Embolization
Description: Portal Vein embolization with Glue by a transhepatic approach
- ProcedureHepatic Vein Embolization
Hepatic Vein Embolization with Vascular plugs via a transjugular or transfemoral approach in the same session as the PVE procedure
Locations (55)
- Yale School of Medicine HospitalNew Haven, Connecticut
- Rush University Medical CenterChicago, Illinois
- Mayo ClinicRochester, Minnesota
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Cleveland ClinicCleveland, Ohio
- Monash Medical CenterMelbourne