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

被引：23

作者：

Korenblik, R. ^{[1
,2
]}

Olij, B. ^{[1
,2
]}

Aldrighetti, L. A. ^{[10
]}

Abu Hilal, M. ^{[11
]}

Ahle, M. ^{[12
]}

Arslan, B. ^{[8
]}

van Baardewijk, L. J. ^{[13
]}

Baclija, I ^{[14
]}

Bent, C. ^{[15
,16
]}

Bertrand, C. L. ^{[17
]}

Bjornsson, B. ^{[18
]}

de Boer, M. T. ^{[19
]}

de Boer, S. W. ^{[3
]}

Bokkers, R. P. H. ^{[20
]}

Rinkes, I. H. M. Borel ^{[21
]}

Breitenstein, S. ^{[6
]}

Bruijnen, R. C. G. ^{[22
]}

Bruners, P. ^{[5
]}

Camacho, J. C. ^{[24
]}

Cappelli, A. ^{[25
]}

Carling, U. ^{[26
]}

Chan, B. K. Y. ^{[27
]}

Chang, D. H. ^{[28
]}

Choi, J. ^{[29
]}

Codina Font, J. ^{[30
]}

Crawford, M. ^{[31
]}

Croagh, D. ^{[32
]}

Cugat, E. ^{[33
]}

Davis, R. ^{[34
]}

De Boo, D. W. ^{[35
]}

De Cobelli, F. ^{[36
]}

De Wispelaere, J. F. ^{[37
]}

van Delden, O. M. ^{[38
]}

Delle, M. ^{[39
]}

Detry, O. ^{[40
]}

Dili, A. ^{[17
]}

Erdmann, J., I ^{[41
]}

Fisher, O. ^{[31
]}

Fondevila, C. ^{[42
]}

Fretland, A. ^{[43
]}

Garcia Borobia, F. ^{[44
]}

Gelabert, A. ^{[45
,46
]}

Gerard, L. ^{[47
]}

Giuliante, F. ^{[48
]}

Gobardhan, P. D. ^{[49
]}

Gomez, F. ^{[50
]}

Grunberger, T. ^{[51
]}

Grunhagen, D. J. ^{[52
]}

Guitart, J. ^{[46
]}

Hagendoorn, J. ^{[21
]}

机构：

[1] Maastricht Univ, GROW Sch Oncol & Dev Biol, Maastricht Univ Singel 40, NL-6229 ET Maastricht, Netherlands

[2] Maastricht Univ Med Ctr, Dept Surg, Maastricht, Netherlands

[3] Maastricht Univ Med Ctr, Dept Radiol & Nucl Med, Maastricht, Netherlands

[4] Univ Hosp Aachen, Dept Gen Visceral & Transplant Surg, Aachen, Germany

[5] Univ Hosp Aachen, Dept Radiol, Aachen, Germany

[6] Cantonal Hosp Winterthur, Dept Gen & Visceral Surg, Winterthur, Switzerland

[7] Cantonal Hosp Winterthur, Dept Radiol, Winterthur, Switzerland

[8] Rush Univ Med Ctr, Dept Radiol, Chicago, IL USA

[9] Rush Univ Med Ctr Chicago, Dept Surg, Chicago, IL USA

[10] Osped San Raffaele, Dept Surg, Milan, Italy

[11] Fdn Poliambulanza, Dept Surg, Brescia, Italy

[12] Univ Hosp, Dept Radiol, Linkoping, Sweden

[13] Maxima Med Ctr, Dept Radiol, Eindhoven, Netherlands

[14] Clin Favoriten, Dept Radiol, Vienna, Austria

[15] Royal Bournemouth & Christchurch Hosp, Dept Radiol, Bournemouth, Dorset, England

[16] Royal Bournemouth & Christchurch Hosp, Dept Radiol, christuchurch, England

[17] CHU UCLouvain Namur, Dept Surg, Namur, Belgium

[18] Linkoping Univ Hosp, Dept Surg Biomed & Clin Sci, Linkoping, Sweden

[19] Univ Med Ctr Groningen, Dept Surg, Groningen, Netherlands

[20] Univ Med Ctr Groningen, Dept Radiol, Groningen, Netherlands

[21] Univ Med Ctr Utrecht, Dept Surg, Utrecht, Netherlands

[22] Univ Med Ctr Utrecht, Dept Radiol, Utrecht, Netherlands

[23] Univ Hosp Heidelberg, Dept Surg, Heidelberg, Germany

[24] Mem Sloan Kettering Canc Ctr, Dept Radiol, 1275 York Ave, New York, NY 10021 USA

[25] St Orsola Malpighi Hosp, Dept Radiol, IRCCS Azienda Osped Univ Bologna, Bologna, Italy

[26] Univ Hosp Oslo, Dept Radiol, Oslo, Norway

[27] Aintree Univ Hosp NHS Fdn Trust, Dept Surg, Liverpool, Merseyside, England

[28] Univ Hosp Heidelberg, Dept Radiol, Heidelberg, Germany

[29] Western Hlth Footscray, Dept Surg, Footscray, Vic, Australia

[30] Univ Hosp Dr Josep Trueta Girona, Dept Radiol, Girona, Spain

[31] Royal Prince Alfred Hosp, Dept Surg, Camperdown, NSW, Australia

[32] Monash Hlth, Dept Surg, Clayton, Vic, Australia

[33] Univ Hosp Germans Trias I Pujol, Dept Surg, Badalona, Spain

[34] Aintree Univ Hosp NHS Fdn Trust, Dept Radiol, Liverpool, Merseyside, England

[35] Monash Hlth, Dept Radiol, Clayton, Vic, Australia

[36] Osped San Raffaele, Dept Radiol, Milan, Italy

[37] CHU UCLouvain Namur, Dept Radiol, Namur, Belgium

[38] Amsterdam Univ Med Ctr Locat AMC, Dept Radiol, Amsterdam, Netherlands

[39] Karolinska Univ Hosp, Dept Radiol, Stockholm, Sweden

[40] CHU Liege, Dept Surg, Liege, Belgium

[41] Amsterdam Univ Med Ctr Locat AMC, Dept Surg, Amsterdam, Netherlands

[42] Hosp Clin Barcelona, Dept Surg, Barcelona, Spain

[43] Univ Hosp Oslo, Dept Surg, Oslo, Norway

[44] Hosp Parc Tauli Sabadell, Dept Surg, Sabadell, Spain

[45] Hosp Parc Tauli Sabadell, Dept Radiol, Sabadell, Spain

[46] Univ Hosp Mutua Terassa, Dept Radiol, Terassa, Spain

[47] CHU Liege, Dept Radiol, Liege, Belgium

[48] Gemelli Univ Hosp Rome, Dept Surg, Rome, Italy

[49] Amphia, Dept Surg, Breda, Netherlands

[50] Hosp Clin Barcelona, Dept Radiol, Barcelona, Spain

来源：

CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY | 2022年 / 45卷 / 09期

关键词：

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); HEPATOBILIARY SCINTIGRAPHY; 2-STAGE HEPATECTOMY; VENOUS DEPRIVATION; COMPLETE RESECTION; MAJOR HEPATECTOMY; MULTIPLE;

D O I：

10.1007/s00270-022-03176-1

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：1391 / 1398

页数：8

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