2023-05-24 02:15:31
A. Background and problem definition
Primary Liver cancer is a very serious disease with a poor survival rate. Surgery prolongs survival and gives a chance of recovery. Unfortunately, many patients cannot be operated on. In some patients the disease is too extensive, in others the part of the liver that is still healthy, the future residual liver, is too small to operate safely.
Performing surgery in patients with a too small future residual liver can lead to postoperative liver failure. These patients often die from this. The DRAGON Primary trial was set up to help patients with a residual liver that is too small. Through this study, a new technique will be investigated: combined portal and hepatic vein embolization, abbreviated PVE/HVE. In this, the blood supply to (the portal vein) and venous drainage (the hepatic vein) of one part of the liver (the diseased side) is closed, causing the other part of the liver to grow. When the “healthy” part of the liver has sufficient size, the final liver operation can still take place.
Whether this new technique, compared to the current treatment, gives a better chance of surgery and/or survival gain in patients with primary liver cancer has not yet been investigated.
B. Research direction/proposed solution
In this study, the DRAGON Primary trial, it is investigated whether combined portal vein embolization and hepatic vein embolization is better than portal vein embolization alone in the treatment of patients with primary liver cancer and a future residual liver that is too small.
C. Relevance
The safety of PVE/HVE has recently been proven in the DRAGON 1 trial. This technique is currently being investigated in patients with colorectal liver metastases, the DRAGON 2 trial. Currently, in addition to the DRAGON 2 trial, there is also a French study into this technique, but unfortunately only 64 patients (32 per arm) are included in this French study. Unfortunately, this is too little to compare the chance of surgery and survival after the technique between the two groups. Patients with various causes of liver cancer (primary liver cancer and metastases) are also included in this French study. In summary, the DRAGON Primary trial is therefore necessary to investigate whether PVE/HVE leads to a better chance of surgery and survival.
D. Research Questions
-Provides PVE/HVE for more future residual liver growth.
-Provides PVE/HVE for a greater chance of surgery
-Leads PVE/HVE to survivability
E. Research design
The DRAGON Primary trial is part of the DRAGON research group. In this study, 348 patients will be randomized between the new technique, PVE/HVE, and the current treatment PVE. Approximately 40 hospitals worldwide will participate in this study, including 7 Dutch hospitals.
F. Expected Outcomes
It is expected that PVE/HVE, compared to the current treatment (PVE alone), is better able to grow the future residual liver in patients with primary liver tumors and a too small residual liver. This will increase the chance of surgery. This will result in longer survival.
G. Description of steps required to implement result
First of all, the DRAGON Primary must be performed after which the results can be analyzed. In addition to scientific and non-scientific publications, the results will be presented at national and international conferences. The results will also be used to determine new international guidelines.
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