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Spots Global Cancer Trial Database for DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Combined PVE/HVE

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Trial Identification

Brief Title: DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Combined PVE/HVE

Official Title: DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization to Accelerate Future Liver Remnant (FLR) Hypertrophy

Study ID: NCT04272931

Conditions

Colorectal Cancer Liver Metastases

Interventions

Portal and Hepatic Vein Embolization

Study Description

Brief Summary: Brief Summary: Some colorectal liver metastases can only be resected after inducing liver regeneration by portal vein embolization (PVE) to increase size function of the future liver remnant (FLR). While PVE is standard, embolization of portal vein and hepatic veins (PVE/HVE) on one side of the liver may faster and more extensive liver size and function growth. PVE/HVE is a novel procedure and requires a safety and feasibility evaluation in a pretrial (DRAGON1) to then be compared in a randomized controlled trial (RCT) to PVE (DRAGON 2).

Detailed Description: Detailed Description: Resection of liver metastases from colorectal cancer (CRLM) improves survival compared to chemotherapy alone and may lead to cure in up to 40% of patients. Surgical resectability is limited by location of metastases and by FLR size and function. Commonly, the volume of the future liver remnant (FLR) should be at least 30% of the functional FLR volume. If this volume criterion is not met, the induction of liver regeneration between a two-stage hepatectomy is performed at many centers, with the aim to render patients resectable and reduce the risk of post hepatectomy liver failure. Gold standard to induce regeneration is the embolization of the portal vein branches to the tumor carrying liver (PVE) to induce regeneration of the FLR. Recently, combined embolization of both portal and hepatic veins (PVE/HVE) has been described as an alternative to portal vein embolization because it accelerates and increases growth of the FLR. PVE/HVE combines simultaneous embolization of the portal main branches into the tumor bearing liver and the hepatic vein draining them. The tissue in the part of the liver treated with PVE/HVE stays viable because the hepatic artery continues to supplies the liver deprived of portal and hepatic veins. Preclinical studies in pigs have demonstrated feasibility of this method and human case series show accelerated and increased liver growth. No multi-center evaluation has been performed so far. DRAGON 1 is an international, prospective, multi-center trial to test enrolment capacity of participants and safety of portal and hepatic vein embolization (PVE/HVE). DRAGON 1 will form the basis of the RCT DRAGON 2 to compare PVE with PVE/HV. DRAGON 2 is expected to start in 2021.

Keywords

Future Liver Remnant

Portal and Hepatic Vein Embolization

Colorectal Liver Metastases

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Yale School of Medicine, New Haven, Connecticut, United States

Rush University Medical Center, Chicago, Illinois, United States

Memorial Sloan Kettering Cancer Center, New York, New York, United States

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Monash Health, Clayton, Clayton, Victoria, Australia

Social Medical Center, South, Vienna, , Austria

Hôpital Erasme, Brussels, Bruxelles, Belgium

CHU-UCL Namur site Godinne, Yvoir, Namen, Belgium

CHU de Liège, Liège, , Belgium

The Ottawa Hospital, Ottawa, Ontario, Canada

McGill University Health Center, Montréal, , Canada

Klinikum Saarbrücken gGmbH, Saarbrücken, Saarland, Germany

University Hospital Halle (Saale), Halle (Saale), Saksen-Anhalt, Germany

Frankfurt University Hospital, Frankfurt, , Germany

Policlinico Sant'Orsola-Malpighi, Bologna, , Italy

Fondazione Poliambulanza, Brescia, , Italy

IRCCS San Raffaele Hospital, Milan, , Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, , Italy

Maastricht University Medical Center+, Maastricht, Limburg, Netherlands

Amsterdam UMC, location AMC, Amsterdam, Noord-Holland, Netherlands

Erasmus Medical Center, Rotterdam, Zuid-Holland, Netherlands

Amsterdam Medical Centers, Location VUmc, Amsterdam, , Netherlands

Amphia, Breda, , Netherlands

Maxima Medisch Centrum, Eindhoven, , Netherlands

University Medical Center Groningen, Groningen, , Netherlands

Universitair Medisch Centrum Utrecht, Utrecht, , Netherlands

Oslo University Hospital, Oslo, , Norway

University Hospital Germans Trias I Pujol, Badalona, Barcelona, Spain

University Hospital Parc Taulí, Sabadell, Barcelona, Spain

Hospital Universitari Mútua Terrassa, Terrassa, Barcelona, Spain

Hospital Universitari Dr. Josep Trueta, Girona, Gerona, Spain

Clínic de Barcelona, Barcelona, , Spain

University Hospital Miguel Servet, Zaragoza, , Spain

Linköping University Hospital, Linköping, , Sweden

Karolinska University Hospital, Stockholm, , Sweden

Claraspital & Clarunis University Hospital Basel, Basel, Basel-Stadt, Switzerland

Kantonsspital Winterthur (KSW), Winterthur, , Switzerland

University Hospital Southampton, Southampton, Hampshire, United Kingdom

Aintree University Hospital, Liverpool, Merseyside, United Kingdom

Belfast Health and Social Care Trust, Belfast, , United Kingdom

King's college hospital NHS foundation trust, London, , United Kingdom

Oxford University Hospitals NHS Foundation Trust, Oxford, , United Kingdom