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

Korenblik, Remon; Olij, B.; Aldrighetti, Luca; Hilal, Mohammad Abu; Ahle, Margareta; Arslan, Bülent; Baardewijk, Laurens J. van; Baclija, I; Bent, Clare; Bertrand, C.; Björnsson, Bergþór; Boer, Marieke T. de; Boer, Sanne W de; Bokkers, Reinoud P H; Rinkes, Inne H.M. Borel; Breitenstein, Stefan; Bruijnen, R.; Bruners, Philipp; Büchler, Markus W.; Camacho, Juan C.; Cappelli, Alberta; Carling, Ulrik; Chan, B; Chang, De‐Hua; Choi, Jin‐Su; Font, J Codina; Crawford, Michael; Croagh, Daniel; Cugat, Esteban; Davis, R; Boo, D W De; Cobelli, Francesco De; Wispelaere, J F De; Delden, Otto M. van; Delle, Martin; Detry, Olivier; Díaz-Nieto, Rafael; Dili, Alexandra; Erdmann, Joris I.; Fisher, Oliver M.; Fondevila, Constantino; Fretland, Å.A.; Borobia, Francisco G.; Gelabert, A; Gérard, Laurent; Giuliante, Felice; Gobardhan, Paul D.; Gómez, Fernando; Grünberger, Thomas; Grünhagen, Dirk J.; Guitart, J; Hagendoorn, Jeroen; Heil, Jan; Heise, Daniel; Herrero, Eduardo Ferrero; Hess, Gabriel Fridolin; Hoffmann, M H; Iezzi, Roberto; Imani, Farshad; Nguyen, J; Jovine, Elio; Kalff, Jörg C.; Kazemier, Geert; Kingham, T. Peter; Kleeff, Joerg; Kollmar, Otto; Leclercq, Wouter K G; Ben, Santiago López; Lucidi, Valério; Macdonald, Andrew; Madoff, David C.; Manekeller, Steffen; Martel, Guillaume; Mehrabi, Arianeb; Mehrzad, Homoyoon; Meijerink, Martijn R.; Menon, Krishna; Metrakos, Peter; Meyer, Christian; Moelker, Adriaan; Modi, Sachin; Montanari, N; Navinés, Jordi; Neumann, Ulf; Peddu, Praveen; Primrose, John; Qu, Xu-Dong; Raptis, Dimitri A.; Ratti, Francesca; Ridouani, Fourat; Rogan, Christopher; Ronellenfitsch, Ulrich; Ryan, Sara; Sallemi, Claudio; Moragues, J. Sampere; Sandström, Per; Sarria, L.; Schnitzbauer, Andreas A.; Serenari, Matteo; Serrablo, Alejandro; Smits, Mark; Sparrelid, Ernesto; Spüntrup, Elmar; Stavrou, Gregor A.; Sutcliffe, Robert P.; Tancredi, I; Tasse, J.; Udupa, Venkatesha; Valenti, David; Fundora, Y.; Vogl, Thomas; Wang, Xu‐Wen; White, Steve; Wohlgemuth, Walter A.; Yu, D; Zijlstra, IJ A J; Binkert, Christoph A.; Bemelmans, M. H. A.; Leij, Christiaan van der; Schadde, Erik; Dam, Ronald M. van

doi:10.1007/s00270-022-03176-1

Cited by 15 publications

(2 citation statements)

References 25 publications

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“…RCTs with larger sample sizes are needed to make reliable statements on the actual effect of PVE/HVE compared with PVE. Two prospective trials are currently in progress, the HYPER-LIV01 (registration number: NCT03841305; http://www.clinicaltrials.gov ) and DRAGON 1 trial (registration number: NCT04272931; http://www.clinicaltrials.gov ) 43 , 44 . The global multicentric DRAGON 2 RCT (registration number: NCT05428735; ( http://www.clinicaltrials.gov ) was just ethically approved and will commence later this year.…”

Section: Discussionmentioning

confidence: 99%

Resectability of bilobar liver tumours after simultaneous portal and hepatic vein embolization versus portal vein embolization alone: meta-analysis

et al. 2022

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Background Many patients with bi-lobar liver tumours are not eligible for liver resection due to an insufficient future liver remnant (FLR). To reduce the risk of posthepatectomy liver failure and the primary cause of death, regenerative procedures intent to increase the FLR before surgery. The aim of this systematic review is to provide an overview of the available literature and outcomes on the effectiveness of simultaneous portal and hepatic vein embolization (PVE/HVE) versus portal vein embolization (PVE) alone. Methods A systematic literature search was conducted in PubMed, Web of Science, and Embase up to September 2022. The primary outcome was resectability and the secondary outcome was the FLR volume increase. Results Eight studies comparing PVE/HVE with PVE and six retrospective PVE/HVE case series were included. Pooled resectability within the comparative studies was 75 per cent in the PVE group (n = 252) versus 87 per cent in the PVE/HVE group (n = 166, OR 1.92 (95% c.i., 1.13–3.25)) favouring PVE/HVE (P = 0.015). After PVE, FLR hypertrophy between 12 per cent and 48 per cent (after a median of 21–30 days) was observed, whereas growth between 36 per cent and 67 per cent was reported after PVE/HVE (after a median of 17–31 days). In the comparative studies, 90-day primary cause of death was similar between groups (2.5 per cent after PVE versus 2.2 per cent after PVE/HVE), but a higher 90-day primary cause of death was reported in single-arm PVE/HVE cohort studies (6.9 per cent, 12 of 175 patients). Conclusion Based on moderate/weak evidence, PVE/HVE seems to increase resectability of bi-lobar liver tumours with a comparable safety profile. Additionally, PVE/HVE resulted in faster and more pronounced hypertrophy compared with PVE alone.

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Section: Discussionmentioning

confidence: 99%

Resectability of bilobar liver tumours after simultaneous portal and hepatic vein embolization versus portal vein embolization alone: meta-analysis

et al. 2022

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“…A novel procedure, i.e., simultaneously performed portal and hepatic vein embolization (PVE/HVE), which aims at preventing formation of collaterals in embolized segments, showed better FLR hypertrophy than PVE alone and had comparable postoperative survival [ 11 – 15 ]. PVE/HVE is currently being further evaluated by the international DRAGON trials collaborative [ 16 , 17 ].…”

Section: Introductionmentioning

confidence: 99%

Influence of cholestasis on portal vein embolization-induced hypertrophy of the future liver remnant

Chang

Korenblik

Olij

et al. 2023

Langenbecks Arch Surg

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Purpose In the pre-clinical setting, hepatocellular bile salt accumulation impairs liver regeneration following partial hepatectomy. Here, we study the impact of cholestasis on portal vein embolization (PVE)-induced hypertrophy of the future liver remnant (FLR). Methods Patients were enrolled with perihilar cholangiocarcinoma (pCCA) or colorectal liver metastases (CRLM) undergoing PVE before a (extended) right hemihepatectomy. Volume of segments II/III was considered FLR and assessed on pre-embolization and post-embolization CT scans. The degree of hypertrophy (DH, percentual increase) and kinetic growth rate (KGR, percentage/week) were used to assess PVE-induced hypertrophy. Results A total of 50 patients (31 CRLM, 19 pCCA) were included. After PVE, the DH and KGR were similar in patients with CRLM and pCCA (5.2 [3.3–6.9] versus 5.7 [3.2–7.4] %, respectively, p = 0.960 for DH; 1.4 [0.9–2.5] versus 1.9 [1.0–2.4] %/week, respectively, p = 0.742 for KGR). Moreover, pCCA patients with or without hyperbilirubinemia had comparable DH (5.6 [3.0–7.5] versus 5.7 [2.4–7.0] %, respectively, p = 0.806) and KGR (1.7 [1.0–2.4] versus 1.9 [0.8–2.4] %/week, respectively, p = 1.000). For patients with pCCA, unilateral drainage in FLR induced a higher DH than bilateral drainage (6.7 [4.9–7.9] versus 2.7 [1.5–4.2] %, p = 0.012). C-reactive protein before PVE was negatively correlated with DH (ρ = − 0.539, p = 0.038) and KGR (ρ = − 0.532, p = 0.041) in patients with pCCA. Conclusions There was no influence of cholestasis on FLR hypertrophy in patients undergoing PVE. Bilateral drainage and inflammation appeared to be negatively associated with FLR hypertrophy. Further prospective studies with larger and more homogenous patient cohorts are desirable.

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Reply to Letter to the Editor: Portal Vein Embolization with Vascular Plug and n-Butyl Cyanoacrylate: Are We There Yet?

Carling

Røsok

Berger

et al. 2022

Cardiovasc Intervent Radiol

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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

Cited by 15 publications

References 25 publications

Resectability of bilobar liver tumours after simultaneous portal and hepatic vein embolization versus portal vein embolization alone: meta-analysis

Resectability of bilobar liver tumours after simultaneous portal and hepatic vein embolization versus portal vein embolization alone: meta-analysis

Influence of cholestasis on portal vein embolization-induced hypertrophy of the future liver remnant

Reply to Letter to the Editor: Portal Vein Embolization with Vascular Plug and n-Butyl Cyanoacrylate: Are We There Yet?

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