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RECRUITING
NCT06914648
NA

The Dragon PLC Trial (DRAGON-PLC)

Sponsor: Maastricht University

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

358

Start Date

2025-04-01

Completion Date

2032-11-15

Last Updated

2025-05-15

Healthy Volunteers

No

Interventions

PROCEDURE

Portal Vein Embolization

Description: Portal Vein embolization with Glue by a transhepatic approach

PROCEDURE

Hepatic 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 Hospital

New Haven, Connecticut, United States

Rush University Medical Center

Chicago, Illinois, United States

Mayo Clinic

Rochester, Minnesota, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Monash Medical Center

Melbourne, Australia

Medical University of Vienna

Vienna, Vienna, Austria

Social Center South

Vienna, Vienna, Austria

Erasmus Hospital

Brussels, Brussels Capital, Belgium

UZ Antwerpen

Antwerp, Edegem, Belgium

UZ Gent

Ghent, Gent, Belgium

CHU Liège

Liège, Liège, Belgium

CHU-UCL Namur site Godinne (UCLouvain)

Yvoir, Namen, Belgium

Cliniques Universitaires Saint Luc, UCLouvain

Brussels, Belgium

Jessa Hospital

Hasselt, Belgium

UZ Brussel

Jette, Belgium

AZ Groeninge Hospital Kortrijk

Kortrijk, Belgium

Foothills Medical Center

Calgary, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, Canada

Juravinski Hospital and Cancer Centre

Hamilton, Ontario, Canada

Kingston Health Sciences Centre

Kingston, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

St. Joseph's Health Centre

Toronto, Ontario, Canada

Sunnybrook Hospital

Toronto, Ontario, Canada

University Health Network/TGH

Toronto, Ontario, Canada

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Centre Hospitalier de l'Université de Montréal

Montreal, Canada

McGill University Health Centre, Montreal

Montreal, Canada

L'Hopital d'Ottawa

Ottawa, Canada

Royal University Hospital

Saskatoon, Canada

Universitätklinikum Köln

Cologne, Germany

Universitätklinikum Dresden

Dresden, Germany

Universitätklinikum Hannover

Hanover, Germany

Ospedale San Raffaele

Milan, Italy

Maastricht Universitair Medisch Centrum+

Maastricht, Limburg, Netherlands

Amsterdam UMC, location VUMC

Amsterdam, North Holland, Netherlands

Maxima Medisch Centrum

Eindhoven, Netherlands

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Leiden Universitair Medisch Centrum

Leiden, Netherlands

University Hospital Oslo

Oslo, Norway

University Hospital Linköping

Linköping, Sweden

Karolinska University Hospital Stockholm

Stockholm, Sweden

Cantonal Hospital Winterthur

Winterthur, Canton of Zurich, Switzerland

Claraspital Basel

Basel, Switzerland

Universitätsspital Basel

Basel, Switzerland

CHUV - Lausanne University Hospital

Lausanne, Switzerland

Hirslanden Klinik St. Anna

Lucerne, Switzerland

Hirslanden Klinik

Zurich, Switzerland

Belfast Health and Social Care Trust

Belfast, United Kingdom

Queen Elizabeth Hospital

Birmingham, United Kingdom

Aintree University Hospital

Liverpool, United Kingdom

Kings college Hospital

London, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

University Hospital Southampton

Southampton, United Kingdom