The DRAGON-PLC trial is an international study exploring how we can improve the treatment of patients with primary liver cancer, such as hepatocellular carcinoma and cholangiocarcinoma. For many of these patients, surgery offers the best chance of recovery. However, in some patients, removing part of the liver during surgery would leave the remaining liver too small to function properly, making surgery unsafe.
To get around this issue, Portal Vein Embolization (PVE) has been used for years to help the liver grow before surgery. During this procedure, a blood vessel that supplies blood to a part of the liver is blocked, which causes the healthy part of the liver to grow larger. This is essential to ensure that enough healthy liver remains after part of it is removed. Although this technique is often effective, in some patients the liver does not grow quickly or large enough to make surgery possible.
The DRAGON-PLC trial is investigating a new treatment method that could allow even more patients to undergo surgery, increasing their chances of recovery. This new technique called Portal and Hepatic Vein Embolization (PVE/HVE) might turn out to be an improved version of the existing treatment. In addition to blocking the blood vessel that brings blood to the liver, a blood vessel that carries blood away from the liver is also blocked. The idea is that this will help the healthy part of the liver grow even faster and larger than with the standard treatment (PVE only). The researchers hope that this will enable more patients to undergo surgery sooner.
The goal of the DRAGON-PLC trial is to determine if this new treatment can help more patients. The researchers are not only looking at how well the liver grows, but also at the safety of the technique and at how well patients recover. Additionally, they are studying how this treatment affects patients' quality of life. By comparing the results to the standard treatment, they hope to gain a clearer understanding of what PVE/HVE could mean for people with liver cancer.
| Title | An international multicentre randomised controlled trial to compare combined Portal and Hepatic Vein Embolisation (PVE/HVE) with PVE alone in patients with primary liver cancers. |
| Participants (P) | Patients with primarily unresectable/potentially resectable Hepatocellular Carcinoma (HCC), Intrahepatic cholangiocarcinoma (iCCC) or Perihilar cholangiocarcinoma (pCCC) |
| Intervention (I) | Combined Portal Vein and Hepatic Vein Embolisation (PVE/HVE) |
| Control (C) | Portal Vein Embolisation (PVE) only |
| Outcome (O) | 1. Resectability: Future Liver Remanant (FLR) volume is ≥30% in normally functioning livers, ≥40% in livers with potentially impaired function, or ≥50% in livers with severely impaired function resulting from liver cirrhosis OR for any FLR volume function on hepatobiliary scintigraphy (HEBIS) is >2.67 %/min/m2 2. Survival: Patient alive 5 years after embolisation |
| Trial Design | An international multicentre randomised controlled trial in which patients will be randomised (1:1) in centre and cancer type-stratified blocks into two arms: combined PVE/HVE and PVE alone. |
| Sample Size | 66 patients in Belgium (internationally 358 patients will be included, 179 patients per arm). |
| Trial duration | 48 months |
| Budget | 522 000 Euros |
| Sponsor | Maastricht University Medical Center (MUMC+) CHULiège (Belgian Coordinating Centre) |
| Chief Investigator | Prof dr R.M. van Dam (NL) Prof dr O. Detry (BE) |
| Number of participating sites | 8 |
Clinicaltrials.gov: tbc
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