Colorectal Cancer Liver MetastasesDRAGONNCT04272931
DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Combined PVE/HVE
A study testing Portal and Hepatic Vein Embolization in people with Colorectal Cancer Liver Metastases, run by Maastricht University at 42 sites in 13 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Liver Metastases
- What is being tested?
- Portal and Hepatic Vein Embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 42 sitesin 13 countries
- Study dates
- 8 May 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primarily unresectable/potentially resectable CRLM after conversion chemotherapy with a FLR <30% in normal livers, or 40% in livers chemotherapy damaged livers.
- 18 years and older
- Patients up to ECOG 3 (not more than 50% bedbound)
- Patients with non-resected primary colorectal cancer (CRC) may be included if and only if there is an intent to remove the CRC after the liver treatment (liver first approach)
- Staging CT chest and (if symptomatic) CT/MRI excludes unresectable extrahepatic disease, while metastatic disease that may be cured in the future, is included.
- Patients with resectable lung metastases or lung metastases that and be ablated can be included only after statement about resectability/ablatability by tumor board
- Patients have to be to understand the trial and provide informed consent.
Who cannot join
- Patients with extrahepatic disease other than lung metastases
- Patients with metastatic disease to the lung that cannot be ablated or resected will be excluded
- Patients with intrahepatic Cholangiocarcinoma (IHCC)
- Patients with Perihilar Cholangiocarcinoma (PHCC)
- Patients with Hepatocellular Carcinoma (HCC)
- Pregnant or lactating women will not be eligible
- Potential to get pregnant has to be excluded (obligatory contraception etc.)
- Progression by modified RECIST criteria on cross-sectional imaging after conversion chemotherapy is an exclusion criterion. Complete response in cross-sectional imaging after conversion chemotherapy.
Trial locations and contacts
42 sites in 13 countries.
42 sites in 13 countries
Netherlands8 sites
Amsterdam UMC, location AMC
Amsterdam, North Holland, 1105 AZ
Amsterdam Medical Centers, Location VUmc
Amsterdam, 1081HV
Amphia
Breda
Maxima Medisch Centrum
Eindhoven
University Medical Center Groningen
Groningen, 9713 GZ
Maastricht University Medical Center+
Maastricht, Limburg, 6229 HX
Erasmus Medical Center
Rotterdam, South Holland, 3015
Universitair Medisch Centrum Utrecht
Utrecht
Spain6 sites
University Hospital Germans Trias I Pujol
Badalona, Barcelona, 08916 Badalona
Clínic de Barcelona
Barcelona, 08036
Hospital Universitari Dr. Josep Trueta
Girona, Gerona, 17007
University Hospital Parc Taulí
Sabadell, Barcelona, 08208
Hospital Universitari Mútua Terrassa
Terrassa, Barcelona, 08221
University Hospital Miguel Servet
Zaragoza, 50009
United Kingdom5 sites
Belfast Health and Social Care Trust
Belfast
Aintree University Hospital
Liverpool, Merseyside, L9 7AL
King's college hospital NHS foundation trust
London
Oxford University Hospitals NHS Foundation Trust
Oxford
University Hospital Southampton
Southampton, Hampshire, SO16 6YD
Italy4 sites
Policlinico Sant'Orsola-Malpighi
Bologna, 40138
Fondazione Poliambulanza
Brescia, 25124
IRCCS San Raffaele Hospital
Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168 Roma
United States3 sites
Rush University Medical Center
Chicago, Illinois, 60612
Yale School of Medicine
New Haven, Connecticut, 06510
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Belgium3 sites
Hôpital Erasme
Brussels, Brussels Capital, 1070
CHU de Liège
Liège, 4000
CHU-UCL Namur site Godinne
Yvoir, Namen, 5530
Germany3 sites
Frankfurt University Hospital
Frankfurt
University Hospital Halle (Saale)
Halle, Saxony-Anhalt, 06120
Klinikum Saarbrücken gGmbH
Saarbrücken, Saarland, 66119
Australia2 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales, NSW 2050
Monash Health, Clayton
Clayton, Victoria, VIC 3168
Canada2 sites
McGill University Health Center
Montreal
The Ottawa Hospital
Ottawa, Ontario, k1H 8L6
Sweden2 sites
Linköping University Hospital
Linköping, 581 85
Karolinska University Hospital
Stockholm, 14186
Switzerland2 sites
Claraspital & Clarunis University Hospital Basel
Basel, Canton of Basel-City, CH-4058
Kantonsspital Winterthur (KSW)
Winterthur, 8401
About this study
Official title: DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization to Accelerate Future Liver Remnant (FLR) Hypertrophy
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).
Read the 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.
- Conditions
- Colorectal Cancer Liver Metastases
- Being tested
- Portal and Hepatic Vein Embolization
- Keywords
- Future Liver Remnant, Portal and Hepatic Vein Embolization, Colorectal Liver Metastases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portal and Hepatic Vein EmbolizationProcedure or surgery
Also called Liver venous deprivation (LVD), Double embolization
Procedure/Surgery: Combined portal vein embolization and hepatic vein embolization (PVE/HVE) • All techniques of PVE allowed (ipsi-lateral, contra-lateral, trans-splenic, all embolization agents except for ethanol alone) • All modifications of HVE allowed (venous occlusion umbrellas; trans-jugular, trans-hepatic, no use of vein glue to avoid lung embolization; staged approach allowed, but first PVE, then HVE and within 48 hours)
| Study group | Role | What they receive |
|---|---|---|
| Portal and Hepatic Vein Embolization | Experimental | 3 patients per center over one year approximately 90 patients in total. Patients will undergo portal vein and hepatic vein embolization instead of only portal vein embolization. Receives: Procedure: Portal and Hepatic Vein Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of each center to enroll 3 patients in 12 months without mortality due to the intervention.
Ability of each center to enroll 3 patients for PVE/HVE in 12 months safely and perform the procedure including the liver resection without 90-day mortality after resection due to complications. If this goal is achieved center will be enrolled in DRAGON 2.
Measured: 1 year/ 90 day mortality
Secondary outcomes (7)
Efficacy assessment: standardized future liver remnant volume
Increased of standardized future liver remnant volume between initial imaging and imaging at 1 week, 3 weeks, 6 weeks, degree of hypertrophy based on standard future liver remnant volume, kinetic growth
Measured: 6 weeks
Feasibility assessment: resection rate
ion of patients proceeding to complete resection (=resection rate)
Measured: 1 year follow up
Mortality assessment
90-mortality after resection
Measured: 90 days
Overall survival after PVE/HVE
Overall survival
Measured: 1 year follow up
Oncological effectiveness of PVE/HVE
Disease-free survival after 1 year
Measured: 1 year
General complication assessment
90-day complications, general (Clavien-Dindo)
Measured: 90 days
Liver specific complication assessment
90-day complications, liver specific (FABIB-classification)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start8 May 2020
- Primary completion1 Oct 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer Liver MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicenter, 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 a planned subsequent trial ("DRAGON 2") that will compare PVE with PVE/HVE. In DRAGON 1 every center has to demonstrate the ability to enroll 3 patients in 12 months safely
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- Koningin Wilhelmina Fonds
- Responsible party
- Sponsor
- Investigators
- Ronald M van Dam, MD PhD, Principal investigator, Maastricht University Medical CenterErik Schadde, MD FACS FEBS, Principal investigator, Kantonsspital Winterthur/ Rush University Medical Center, ChicagoMarc AH Bemelmans, MD PhD, Principal investigator, Maastricht University Medical CenterChristiaan van der Leij, MD PhD, Principal investigator, Maastricht University Medical CenterChristoph A Binkert, Prof.Dr.Med, Principal investigator, Cantonal Hospital Winterthur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272931
- Sponsor's protocol ID
- NL71535.068.19
- Acronym
- DRAGON
- Status last verified
- Feb 2023
- First submitted
- 7 Jan 2020
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: upon reasonable request after publication.
Publications
Korenblik R, James S, Smits J, Diaz-Nieto R, Davis R, Chan BKY, Erdmann JI, Zijlstra IAJ, Arntz PJW, Kollmar O, Hoffmann MH, Vass DG, Lindsay R, Serenari M, Cappelli A, Gobardhan PD, Imani F, Suarez YF, Munos FG, Grunhagen DJ, Moelker A, Pieterman KJ, Kleeff J, Wohlgemuth WA, Herrero E, Gelabert A, Breitenstein S, Seeger N, Detry O, Gerard L, Sandstrom PA, Bjornsson B, Aldrighetti LA, De Cobelli F, Leclercq WKG, van Baardewijk LJ, Croagh D, De Boo DW, Kingham TP, Ridouani F, Metrakos P, Valenti D, Kalil J, Fretland AA, Carling U, Martel G, Ryan S, Udupa V, Macdonald A, Tasse JC, Stavrou GA, Spuentrup E, Borobia FG, Criado E, Sparrelid E, Delle M, Navines-Lopez J, Moragues JS, Andorra EC, Schnitzbauer A, Vogl TJ, Heil J, Primrose JN, Modi S, Fouraschen SMG, Bokkers RPH, de Boer MT, Borel Rinkes IHM, Smits MLJ, Gruenberger T, Baclija I, Billingsley KG, Madoff DC, Serrablo A, Sarria L, Wang X, Xudong Q, Winkens B, Olde Damink SWL, Bemelmans MHA, Dewulf MJL, Binkert CA, Schadde E, van der Leij C, van Dam RM; DRAGON collaborative study group. Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1): a multicentre, single-arm clinical trial. Lancet Reg Health Eur. 2025 Apr 10;53:101284. doi: 10.1016/j.lanepe.2025.101284. eCollection 2025 Jun.
PubMed 40255933Korenblik R, Olij B, Aldrighetti LA, Hilal MA, Ahle M, Arslan B, van Baardewijk LJ, Baclija I, Bent C, Bertrand CL, Bjornsson B, de Boer MT, de Boer SW, Bokkers RPH, Rinkes IHMB, Breitenstein S, Bruijnen RCG, Bruners P, Buchler MW, Camacho JC, Cappelli A, Carling U, Chan BKY, Chang DH, Choi J, Font JC, Crawford M, Croagh D, Cugat E, Davis R, De Boo DW, De Cobelli F, De Wispelaere JF, van Delden OM, Delle M, Detry O, Diaz-Nieto R, Dili A, Erdmann JI, Fisher O, Fondevila C, Fretland A, Borobia FG, Gelabert A, Gerard L, Giuliante F, Gobardhan PD, Gomez F, Grunberger T, Grunhagen DJ, Guitart J, Hagendoorn J, Heil J, Heise D, Herrero E, Hess GF, Hoffmann MH, Iezzi R, Imani F, Nguyen J, Jovine E, Kalff JC, Kazemier G, Kingham TP, Kleeff J, Kollmar O, Leclercq WKG, Ben SL, Lucidi V, MacDonald A, Madoff DC, Manekeller S, Martel G, Mehrabi A, Mehrzad H, Meijerink MR, Menon K, Metrakos P, Meyer C, Moelker A, Modi S, Montanari N, Navines J, Neumann UP, Peddu P, Primrose JN, Qu X, Raptis D, Ratti F, Ridouani F, Rogan C, Ronellenfitsch U, Ryan S, Sallemi C, Moragues JS, Sandstrom P, Sarria L, Schnitzbauer A, Serenari M, Serrablo A, Smits MLJ, Sparrelid E, Spuntrup E, Stavrou GA, Sutcliffe RP, Tancredi I, Tasse JC, Udupa V, Valenti D, Fundora Y, Vogl TJ, Wang X, White SA, Wohlgemuth WA, Yu D, Zijlstra IAJ, Binkert CA, Bemelmans MHA, van der Leij C, Schadde E, van Dam RM. Dragon 1 Protocol Manuscript: Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization (PVE/HVE) to Accelerate Future Liver Remnant (FLR) Hypertrophy. Cardiovasc Intervent Radiol. 2022 Sep;45(9):1391-1398. doi: 10.1007/s00270-022-03176-1. Epub 2022 Jul 5.
PubMed 35790566
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization to Accelerate Future Liver Remnant (FLR) Hypertrophy
- ClinicalTrials.gov ID
- NCT04272931
- Acronym / sponsor ID
- DRAGON / NL71535.068.19
- Conditions
- Colorectal Cancer Liver Metastases
- Keywords
- Future Liver Remnant, Portal and Hepatic Vein Embolization, Colorectal Liver Metastases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- Koningin Wilhelmina Fonds
- Study start
- 8 May 2020 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicenter, 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 a planned subsequent trial ("DRAGON 2") that will compare PVE with PVE/HVE. In DRAGON 1 every center has to demonstrate the ability to enroll 3 patients in 12 months safely
| Arm | Type | Receives |
|---|---|---|
| Portal and Hepatic Vein Embolization | Experimental | Procedure: Portal and Hepatic Vein Embolization3 patients per center over one year approximately 90 patients in total. Patients will undergo portal vein and hepatic vein embolization instead of only portal vein embolization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with primarily unresectable/potentially resectable CRLM after conversion chemotherapy with a FLR <30% in normal livers, or 40% in livers chemotherapy damaged livers.
- 18 years and older
- Patients up to ECOG 3 (not more than 50% bedbound)
- Patients with non-resected primary colorectal cancer (CRC) may be included if and only if there is an intent to remove the CRC after the liver treatment (liver first approach)
- Staging CT chest and (if symptomatic) CT/MRI excludes unresectable extrahepatic disease, while metastatic disease that may be cured in the future, is included.
Key exclusion criteria (8 listed)
- Patients with extrahepatic disease other than lung metastases
- Patients with metastatic disease to the lung that cannot be ablated or resected will be excluded
- Patients with intrahepatic Cholangiocarcinoma (IHCC)
- Patients with Perihilar Cholangiocarcinoma (PHCC)
- Patients with Hepatocellular Carcinoma (HCC)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portal and Hepatic Vein EmbolizationAlso: Liver venous deprivation (LVD), Double embolizationProcedure/Surgery: Combined portal vein embolization and hepatic vein embolization (PVE/HVE) • All techniques of PVE allowed (ipsi-lateral, contra-lateral, trans-splenic, all embolization agents except for ethanol alone) • All modifications of HVE allowed (venous occlusion umbrellas; trans-jugular, trans-hepatic, no use of vein glue to avoid lung embolization; staged approach allowed, but first PVE, then HVE and within 48 hours) | Procedure or surgery | Portal and Hepatic Vein Embolization |
Primary outcome
Ability of each center to enroll 3 patients in 12 months without mortality due to the intervention.
Time frame: 1 year/ 90 day mortality
Ability of each center to enroll 3 patients for PVE/HVE in 12 months safely and perform the procedure including the liver resection without 90-day mortality after resection due to complications. If this goal is achieved center will be enrolled in DRAGON 2.
7 secondary outcomes
Efficacy assessment: standardized future liver remnant volume
Time frame: 6 weeks
Feasibility assessment: resection rate
Time frame: 1 year follow up
Mortality assessment
Time frame: 90 days
Overall survival after PVE/HVE
Time frame: 1 year follow up
Oncological effectiveness of PVE/HVE
Time frame: 1 year
General complication assessment
Time frame: 90 days
Liver specific complication assessment
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Derived from this study: PubMed 40255933Korenblik R, James S, Smits J, Diaz-Nieto R, Davis R, Chan BKY, Erdmann JI, Zijlstra IAJ, Arntz PJW, Kollmar O, Hoffmann MH, Vass DG, Lindsay R, Serenari M, Cappelli A, Gobardhan PD, Imani F, Suarez YF, Munos FG, Grunhagen DJ, Moelker A, Pieterman KJ, Kleeff J, Wohlgemuth WA, Herrero E, Gelabert A, Breitenstein S, Seeger N, Detry O, Gerard L, Sandstrom PA, Bjornsson B, Aldrighetti LA, De Cobelli F, Leclercq WKG, van Baardewijk LJ, Croagh D, De Boo DW, Kingham TP, Ridouani F, Metrakos P, Valenti D, Kalil J, Fretland AA, Carling U, Martel G, Ryan S, Udupa V, Macdonald A, Tasse JC, Stavrou GA, Spuentrup E, Borobia FG, Criado E, Sparrelid E, Delle M, Navines-Lopez J, Moragues JS, Andorra EC, Schnitzbauer A, Vogl TJ, Heil J, Primrose JN, Modi S, Fouraschen SMG, Bokkers RPH, de Boer MT, Borel Rinkes IHM, Smits MLJ, Gruenberger T, Baclija I, Billingsley KG, Madoff DC, Serrablo A, Sarria L, Wang X, Xudong Q, Winkens B, Olde Damink SWL, Bemelmans MHA, Dewulf MJL, Binkert CA, Schadde E, van der Leij C, van Dam RM; DRAGON collaborative study group. Safety and efficacy of combined portal and hepatic vein embolisation in patients with colorectal liver metastases (DRAGON1): a multicentre, single-arm clinical trial. Lancet Reg Health Eur. 2025 Apr 10;53:101284. doi: 10.1016/j.lanepe.2025.101284. eCollection 2025 Jun.
- Derived from this study: PubMed 35790566Korenblik R, Olij B, Aldrighetti LA, Hilal MA, Ahle M, Arslan B, van Baardewijk LJ, Baclija I, Bent C, Bertrand CL, Bjornsson B, de Boer MT, de Boer SW, Bokkers RPH, Rinkes IHMB, Breitenstein S, Bruijnen RCG, Bruners P, Buchler MW, Camacho JC, Cappelli A, Carling U, Chan BKY, Chang DH, Choi J, Font JC, Crawford M, Croagh D, Cugat E, Davis R, De Boo DW, De Cobelli F, De Wispelaere JF, van Delden OM, Delle M, Detry O, Diaz-Nieto R, Dili A, Erdmann JI, Fisher O, Fondevila C, Fretland A, Borobia FG, Gelabert A, Gerard L, Giuliante F, Gobardhan PD, Gomez F, Grunberger T, Grunhagen DJ, Guitart J, Hagendoorn J, Heil J, Heise D, Herrero E, Hess GF, Hoffmann MH, Iezzi R, Imani F, Nguyen J, Jovine E, Kalff JC, Kazemier G, Kingham TP, Kleeff J, Kollmar O, Leclercq WKG, Ben SL, Lucidi V, MacDonald A, Madoff DC, Manekeller S, Martel G, Mehrabi A, Mehrzad H, Meijerink MR, Menon K, Metrakos P, Meyer C, Moelker A, Modi S, Montanari N, Navines J, Neumann UP, Peddu P, Primrose JN, Qu X, Raptis D, Ratti F, Ridouani F, Rogan C, Ronellenfitsch U, Ryan S, Sallemi C, Moragues JS, Sandstrom P, Sarria L, Schnitzbauer A, Serenari M, Serrablo A, Smits MLJ, Sparrelid E, Spuntrup E, Stavrou GA, Sutcliffe RP, Tancredi I, Tasse JC, Udupa V, Valenti D, Fundora Y, Vogl TJ, Wang X, White SA, Wohlgemuth WA, Yu D, Zijlstra IAJ, Binkert CA, Bemelmans MHA, van der Leij C, Schadde E, van Dam RM. Dragon 1 Protocol Manuscript: Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization (PVE/HVE) to Accelerate Future Liver Remnant (FLR) Hypertrophy. Cardiovasc Intervent Radiol. 2022 Sep;45(9):1391-1398. doi: 10.1007/s00270-022-03176-1. Epub 2022 Jul 5.
- Individual participant dataSharing planned: Yes. upon reasonable request after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald M van Dam, MD PhD principal investigator
Maastricht University Medical Center
Erik Schadde, MD FACS FEBS principal investigator
Kantonsspital Winterthur/ Rush University Medical Center, Chicago
Marc AH Bemelmans, MD PhD principal investigator
Maastricht University Medical Center
42 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portal and Hepatic Vein Embolization in people with Colorectal Cancer Liver Metastases, run by Maastricht University at 42 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Netherlands, Spain, United Kingdom, Italy, United States and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of each center to enroll 3 patients in 12 months without mortality due to the intervention. (time frame: 1 year/ 90 day mortality). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04272931, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.