RecruitingNot ApplicableNCT05428735

The DRAGON 2 Trial

An International Multicenter Randomized Controlled Trial to Compare Combined Portal and Hepatic Vein Embolization (PVE/HVE) with PVE Alone in Patients with Colorectal Liver Cancer Metastases (CRLM) and a Small Future Liver Remnant (FLR)

Sponsor

Maastricht University

Enrollment

348 participants

Start Date

Apr 1, 2022

Study Type

INTERVENTIONAL

Conditions

Colorectal Cancer Liver Metastases (CRLM)Small Future Liver Remnant (FLR)

Summary

In the randomized controlled DRAGON 2 trial study subjects will be randomized between two arms, PVE alone (control group) and PVE/HVE (interventional group).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

The DRAGON 2 Trial is testing a combined liver procedure — simultaneously shrinking one part of the liver and redirecting blood flow to help the other part grow larger — to make surgery possible for people with colorectal cancer that has spread to the liver (CRLM) but cannot currently be removed because too much liver tissue would need to be removed. **You may be eligible if:** - You have colorectal cancer that has spread to the liver in a pattern that is currently not removable due to insufficient healthy liver tissue remaining after surgery - You are 18 or older - You may have a primary colon tumor that has not yet been removed (as long as there is a plan to address it) - You may have small, treatable lung or brain metastases - You are able to understand and consent to the trial **You may NOT be eligible if:** - You are pregnant or breastfeeding - You have cancer that has spread to organs beyond the liver, lung, or brain in a way that cannot be treated - You have other liver cancers besides colorectal metastases - Your cancer progressed during chemotherapy meant to shrink the tumors - Your cancer completely disappeared with chemotherapy (making surgery unnecessary) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEmbolization

Portal Vein embolization with Glue by a transhepatic approach vs. PVE and Hepatic Vein Occlusion with Vascular plugs via a transjugular or transfemoral approach in the same session as the PVE procedure

Locations(24)

Yale New Haven Hospital

New Haven, Connecticut, United States

Monash Medical Centre

Clayton, Victoria, Australia

Social Medical Center, South

Vienna, State of Vienna, Austria

Hôpital Erasme

Brussels, Brussels Capital, Belgium

CHU de Liège

Liège, Liège, Belgium

CHU-UCL Namur site Godinne

Yvoir, Namen, Belgium

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

Vancouver Coastal Health

Vancouver, British Columbia, Canada

Juravinski Hospital and Cancer Centre

Hamilton, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Sunnybrook Hospital

Toronto, Ontario, Canada

McGill University Health Center

Montreal, Canada

IRCCS San Raffaele Hospital

Milan, Italy

Maastricht University Medical Center+

Maastricht, Limburg, Netherlands

Amsterdam UMC, location AMC

Amsterdam, North Holland, Netherlands

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Amphia

Breda, Netherlands

Maxima Medisch Centrum

Eindhoven, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Linköping University Hospital

Linköping, Sweden

Karolinska University Hospital

Stockholm, Sweden

Claraspital & Clarunis University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Kantonsspital Winterthur (KSW)

Winterthur, Switzerland

View Full Details on ClinicalTrials.gov

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NCT05428735

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