Clinical trial · Interventional
DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Combined PVE/HVE
DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization to Accelerate Future Liver Remnant (FLR) Hypertrophy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Liver Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Portal and Hepatic Vein Embolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Portal and Hepatic Vein Embolization
- description
- 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.
- interventionNames
- Procedure: Portal and Hepatic Vein Embolization
Primary outcomes (1)
- measure
- Ability of each center to enroll 3 patients in 12 months without mortality due to the intervention.
- timeFrame
- 1 year/ 90 day mortality
- description
- 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.
Secondary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (2)
- DERIVEDKorenblik 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. PMID 40255933
- DERIVEDKorenblik 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.