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

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Korenblik, R.Maastricht Univ, Netherlands; Maastricht Univ Med Ctr, Netherlands (author)

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

Article/chapterEnglish2022

Publisher, publication year, extent ...

2022-07-05
Springer,2022
electronicrdacarrier

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LIBRIS-ID:oai:DiVA.org:liu-187431
https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-187431URI
https://doi.org/10.1007/s00270-022-03176-1DOI
http://kipublications.ki.se/Default.aspx?queryparsed=id:150208354URI

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Language:English
Summary in:English

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SwePubSwePub

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Subject category:ref swepub-contenttype
Subject category:art swepub-publicationtype

Notes

Funding Agencies|Dutch Cancer Society (KWF); Abbott Laboratories; Maastricht University; Maastricht University Medical Center; NIHR; Guerbet
Study Purpose The DRAGON 1 trial aims to assess training, implementation, safety and feasibility of combined portal- and hepatic-vein embolization (PVE/HVE) to accelerate future liver remnant (FLR) hypertrophy in patients with borderline resectable colorectal cancer liver metastases. Methods The DRAGON 1 trial is a worldwide multicenter prospective single arm trial. The primary endpoint is a composite of the safety of PVE/HVE, 90-day mortality, and one year accrual monitoring of each participating center. Secondary endpoints include: feasibility of resection, the used PVE and HVE techniques, FLR-hypertrophy, liver function (subset of centers), overall survival, and disease-free survival. All complications after the PVE/HVE procedure are documented. Liver volumes will be measured at week 1 and if applicable at week 3 and 6 after PVE/HVE and follow-up visits will be held at 1, 3, 6, and 12 months after the resection. Results Not applicable. Conclusion DRAGON 1 is a prospective trial to assess the safety and feasibility of PVE/HVE. Participating study centers will be trained, and procedures standardized using Work Instructions (WI) to prepare for the DRAGON 2 randomized controlled trial. Outcomes should reveal the accrual potential of centers, safety profile of combined PVE/HVE and the effect of FLR-hypertrophy induction by PVE/HVE in patients with CRLM and a small FLR.

Subject headings and genre

MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Kardiologi hsv//swe
MEDICAL AND HEALTH SCIENCES Clinical Medicine Cardiac and Cardiovascular Systems hsv//eng
Colorectal cancer liver metastases (CRLM); Portal vein embolization (PVE); Hepatic vein embolization (HVE); Combined portal- and hepatic vein embolization (PVE; HVE); Liver hypertrophy; Future liver remnant (FLR)

Added entries (persons, corporate bodies, meetings, titles ...)

Olij, B.Maastricht Univ, Netherlands; Maastricht Univ Med Ctr, Netherlands (author)
Aldrighetti, L. A.Osped San Raffaele, Italy (author)
Abu Hilal, M.Fdn Poliambulanza, Italy,Oxford Univ Hosp NHS, England,Univ Hosp Heidelberg, Germany,Queen Elizabeth Hosp Birmingham NHS, England,Erasmus MC, Netherlands,Maastricht Univ Med Ctr, Netherlands; Univ Hosp Aachen, Germany (author)
Ahle, Margareta,1966-Region Östergötland, Röntgenkliniken i Linköping(Swepub:liu)marah33 (author)
Arslan, B.Rush Univ Med Ctr, IL USA,Cantonal Hosp Winterthur, Switzerland (author)
van Baardewijk, L. J.Maxima Med Ctr, Netherlands,Hop Erasme, Belgium (author)
Baclija, IClin Favoriten, Austria (author)
Bent, C.Royal Bournemouth & Christchurch Hosp, England; Royal Bournemouth & Christchurch Hosp, England,Aintree Univ Hosp NHS Fdn Trust, England (author)
Bertrand, C. L.CHU UCLouvain Namur, Belgium (author)
Björnsson, Bergthor,1975-Linköpings universitet,Avdelningen för kirurgi, ortopedi och onkologi,Medicinska fakulteten,Region Östergötland, Kirurgiska kliniken US(Swepub:liu)berbj34 (author)
de Boer, M. T.Univ Med Ctr Groningen, Netherlands (author)
de Boer, S. W.Maastricht Univ Med Ctr, Netherlands (author)
Bokkers, R. P. H.Univ Med Ctr Groningen, Netherlands,Kings Coll Hosp NHS, England (author)
Rinkes, I. H. M. BorelUniv Med Ctr Utrecht, Netherlands,St Clara Spital, Switzerland,Gemelli Univ Hosp, Italy,Amsterdam Univ Med Ctr Locat VU, Netherlands (author)
Breitenstein, S.Cantonal Hosp Winterthur, Switzerland (author)
Bruijnen, R. C. G.Univ Med Ctr Utrecht, Netherlands,Royal Prince Alfred Hosp, Australia (author)
Bruners, P.Univ Hosp Aachen, Germany (author)
Camacho, J. C.Mem Sloan Kettering Canc Ctr, NY 10021 USA,Western Hlth Footscray, Australia,Univ Hosp Bonn, Germany,Rush Univ Med Ctr, IL USA (author)
Cappelli, A.St Orsola Malpighi Hosp, Italy (author)
Carling, U.Univ Hosp Oslo, Norway (author)
Chan, B. K. Y.Aintree Univ Hosp NHS Fdn Trust, England (author)
Chang, D. H.Univ Hosp Heidelberg, Germany,Univ Hosp Aachen, Germany (author)
Choi, J.Western Hlth Footscray, Australia (author)
Codina Font, J.Univ Hosp Dr Josep Trueta Girona, Spain (author)
Crawford, M.Royal Prince Alfred Hosp, Australia,Yale Sch Med, CT USA,Univ Hosp Bonn, Germany (author)
Croagh, D.Monash Hlth, Australia,Maastricht Univ Med Ctr, Netherlands (author)
Cugat, E.Univ Hosp Germans Trias I Pujol, Spain (author)
Davis, R.Aintree Univ Hosp NHS Fdn Trust, England,Royal Free Hosp NHS, England (author)
De Boo, D. W.Monash Hlth, Australia (author)
De Cobelli, F.Osped San Raffaele, Italy,Hosp Clin Barcelona, Spain (author)
De Wispelaere, J. F.CHU UCLouvain Namur, Belgium (author)
van Delden, O. M.Amsterdam Univ Med Ctr Locat AMC, Netherlands,Karolinska Univ Hosp, Sweden (author)
Delle, M.Karolinska Univ Hosp, Sweden (author)
Detry, O.CHU Liege, Belgium (author)
Dili, A.CHU UCLouvain Namur, Belgium (author)
Erdmann, J. IAmsterdam Univ Med Ctr Locat AMC, Netherlands,Osped Maggiore Bologna, Italy (author)
Fisher, O.Royal Prince Alfred Hosp, Australia (author)
Fondevila, C.Hosp Clin Barcelona, Spain (author)
Fretland, A.Univ Hosp Oslo, Norway (author)
Garcia Borobia, F.Hosp Parc Tauli Sabadell, Spain (author)
Gelabert, A.Hosp Parc Tauli Sabadell, Spain; Univ Hosp Mutua Terassa, Spain,Klinikum Saarbrucken gGmbH, Germany (author)
Gerard, L.CHU Liege, Belgium,Maxima Med Ctr, Netherlands (author)
Giuliante, F.Gemelli Univ Hosp Rome, Italy,Clarunis Univ Hosp, Switzerland (author)
Gobardhan, P. D.Amphia, Netherlands (author)
Gomez, F.Hosp Clin Barcelona, Spain (author)
Grunberger, T.Clin Favoriten, Austria (author)
Grunhagen, D. J.Erasmus MC, Netherlands (author)
Guitart, J.Univ Hosp Mutua Terassa, Spain (author)
Hagendoorn, J.Univ Med Ctr Utrecht, Netherlands (author)
Heil, J.Univ Hosp Frankfurt, Germany (author)
Heise, D.Univ Hosp Aachen, Germany (author)
Herrero, E.Univ Hosp Mutua Terassa, Spain (author)
Hess, G. F.Clarunis Univ Hosp, Switzerland (author)
Hoffmann, M. H.St Clara Spital, Switzerland (author)
Iezzi, R.Gemelli Univ Hosp, Italy (author)
Imani, F.Amphia, Netherlands (author)
Nguyen, J.Western Hlth Footscray, Australia,Univ Hosp Southampton NHS, England (author)
Jovine, E.Osped Maggiore Bologna, Italy (author)
Kalff, J. C.Univ Hosp Bonn, Germany (author)
Kazemier, G.Amsterdam Univ Med Ctr Locat VU, Netherlands (author)
Kingham, T. P.Mem Sloan Kettering Canc Ctr, NY 10021 USA (author)
Kleeff, J.Univ Hosp Halle Saale, Germany (author)
Kollmar, O.Clarunis Univ Hosp, Switzerland (author)
Leclercq, W. K. G.Maxima Med Ctr, Netherlands (author)
Lopez Ben, S.Univ Hosp Dr Josep Truetade Girona, Spain,Univ Hosp Miguel Servet, Spain (author)
Lucidi, VHop Erasme, Belgium (author)
MacDonald, A.Oxford Univ Hosp NHS, England (author)
Madoff, D. C.Yale Sch Med, CT USA (author)
Manekeller, S.Univ Hosp Bonn, Germany,IRCCS Azienda Osped Univ Bologna, Italy,Univ Med Ctr Utrecht, Netherlands (author)
Martel, G.Ottawa Hosp, Canada (author)
Mehrabi, A.Univ Hosp Heidelberg, Germany (author)
Mehrzad, H.Queen Elizabeth Hosp Birmingham NHS, England (author)
Meijerink, M. R.Amsterdam Univ Med Ctr Locat VU, Netherlands,Maastricht Univ, Netherlands; Maastricht Univ Med Ctr, Netherlands; Univ Hosp Aachen, Germany (author)
Menon, K.Kings Coll Hosp NHS, England (author)
Metrakos, P.McGill Univ Hlth Ctr, Canada (author)
Meyer, C.Univ Hosp Bonn, Germany (author)
Moelker, A.Erasmus MC, Netherlands (author)
Modi, S.Univ Hosp Southampton NHS, England (author)
Montanari, N.Osped Maggiore Bologna, Italy (author)
Navines, J.Univ Hosp Germans Trias I Pujol, Spain (author)
Neumann, U. P.Maastricht Univ Med Ctr, Netherlands; Univ Hosp Aachen, Germany (author)
Peddu, P.Kings Coll Hosp NHS, England,Queen Elizabeth Hosp Birmingham NHS, England (author)
Primrose, J. N.Univ Hosp Southampton NHS, England (author)
Qu, X.Fundan Univ, Peoples R China (author)
Raptis, D.Royal Free Hosp NHS, England (author)
Ratti, F.Osped San Raffaele, Italy (author)
Ridouani, F.Mem Sloan Kettering Canc Ctr, NY 10021 USA (author)
Rogan, C.Royal Prince Alfred Hosp, Australia (author)
Ronellenfitsch, U.Univ Hosp Halle Saale, Germany (author)
Ryan, S.Ottawa Hosp, Canada (author)
Sallemi, C.Fdn Poliambulanza, Italy (author)
Sampere Moragues, J.Univ Hosp Germans Trias I Pujol, Spain (author)
Sandström, Per A,1965-Linköpings universitet,Avdelningen för kirurgi, ortopedi och onkologi,Medicinska fakulteten,Region Östergötland, Kirurgiska kliniken US(Swepub:liu)persa07 (author)
Sarria, L.Univ Hosp Miguel Servet, Spain (author)
Schnitzbauer, A.Univ Hosp Frankfurt, Germany,Newcastle Upon Tyne Hosp NHS, England (author)
Serenari, M.IRCCS Azienda Osped Univ Bologna, Italy (author)
Serrablo, A.Univ Hosp Miguel Servet, Spain (author)
Smits, M. L. J.Univ Med Ctr Utrecht, Netherlands (author)
Sparrelid, E.Karolinska Institutet,Karolinska Univ Hosp, Sweden (author)
Spuntrup, E.Klinikum Saarbrucken gGmbH, Germany (author)
Stavrou, G. A.Klinikum Saarbrucken gGmbH, Germany (author)
Sutcliffe, R. P.Queen Elizabeth Hosp Birmingham NHS, England (author)
Tancredi, IHop Erasme, Belgium (author)
Tasse, J. C.Rush Univ Med Ctr, IL USA (author)
Udupa, VOxford Univ Hosp NHS, England (author)
Valenti, D.McGill Univ Hlth Ctr, Canada (author)
Fundora, Y.Hosp Clin Barcelona, Spain (author)
Vogl, T. J.Univ Hosp Frankfurt, Germany (author)
Wang, X.Fundan Univ, Peoples R China (author)
White, S. A.Newcastle Upon Tyne Hosp NHS, England (author)
Wohlgemuth, W. A.Univ Hosp Halle Saale, Germany (author)
Yu, D.Royal Free Hosp NHS, England (author)
Zijlstra, I. A. J.Amsterdam Univ Med Ctr Locat VU, Netherlands (author)
Binkert, C. A.Cantonal Hosp Winterthur, Switzerland (author)
Bemelmans, M. H. A.Maastricht Univ Med Ctr, Netherlands; Univ Hosp Aachen, Germany (author)
van der Leij, C.Maastricht Univ Med Ctr, Netherlands (author)
Schadde, E.Cantonal Hosp Winterthur, Switzerland; Rush Univ Med Ctr Chicago, IL USA (author)
van Dam, R. M.Maastricht Univ, Netherlands; Maastricht Univ Med Ctr, Netherlands; Univ Hosp Aachen, Germany (author)
Maastricht Univ, Netherlands; Maastricht Univ Med Ctr, NetherlandsOsped San Raffaele, Italy (creator_code:org_t)

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By the author/editor: Korenblik, R.; Olij, B.; Aldrighetti, L. ...; Abu Hilal, M.; Ahle, Margareta, ...; Arslan, B.; show more...; van Baardewijk, ...; Baclija, I; Bent, C.; Bertrand, C. L.; Björnsson, Bergt ...; de Boer, M. T.; de Boer, S. W.; Bokkers, R. P. H ...; Rinkes, I. H. M. ...; Breitenstein, S.; Bruijnen, R. C. ...; Bruners, P.; Camacho, J. C.; Cappelli, A.; Carling, U.; Chan, B. K. Y.; Chang, D. H.; Choi, J.; Codina Font, J.; Crawford, M.; Croagh, D.; Cugat, E.; Davis, R.; De Boo, D. W.; De Cobelli, F.; De Wispelaere, J ...; van Delden, O. M ...; Delle, M.; Detry, O.; Dili, A.; Erdmann, J. I; Fisher, O.; Fondevila, C.; Fretland, A.; Garcia Borobia, ...; Gelabert, A.; Gerard, L.; Giuliante, F.; Gobardhan, P. D.; Gomez, F.; Grunberger, T.; Grunhagen, D. J.; Guitart, J.; Hagendoorn, J.; Heil, J.; Heise, D.; Herrero, E.; Hess, G. F.; Hoffmann, M. H.; Iezzi, R.; Imani, F.; Nguyen, J.; Jovine, E.; Kalff, J. C.; Kazemier, G.; Kingham, T. P.; Kleeff, J.; Kollmar, O.; Leclercq, W. K. ...; Lopez Ben, S.; Lucidi, V; MacDonald, A.; Madoff, D. C.; Manekeller, S.; Martel, G.; Mehrabi, A.; Mehrzad, H.; Meijerink, M. R.; Menon, K.; Metrakos, P.; Meyer, C.; Moelker, A.; Modi, S.; Montanari, N.; Navines, J.; Neumann, U. P.; Peddu, P.; Primrose, J. N.; Qu, X.; Raptis, D.; Ratti, F.; Ridouani, F.; Rogan, C.; Ronellenfitsch, ...; Ryan, S.; Sallemi, C.; Sampere Moragues ...; Sandström, Per A ...; Sarria, L.; Schnitzbauer, A.; Serenari, M.; Serrablo, A.; Smits, M. L. J.; Sparrelid, E.; Spuntrup, E.; Stavrou, G. A.; Sutcliffe, R. P.; Tancredi, I; Tasse, J. C.; Udupa, V; Valenti, D.; Fundora, Y.; Vogl, T. J.; Wang, X.; White, S. A.; Wohlgemuth, W. A ...; Yu, D.; Zijlstra, I. A. ...; Binkert, C. A.; Bemelmans, M. H. ...; van der Leij, C.; Schadde, E.; van Dam, R. M.; show less...

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