Zusammenfassung (Niederländisch oder Französisch oder Englisch)
Trial Description
| 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 |
Trial team
| 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 |
DOCUMENTS
References
Clinicaltrials.gov: tbc
Webpage:
Funding scheme
