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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
- Source :
- Korenblik , R , Olij , B , Aldrighetti , L A , Hilal , M A , Ahle , M , Arslan , B , van Baardewijk , L J , Baclija , I , Bent , C , Bertrand , C L , Björnsson , B , de Boer , M T , de Boer , S W , Bokkers , R P H , Rinkes , I H M B , Breitenstein , S , Bruijnen , R C G , Bruners , P , Büchler , M W , Camacho , J C , Cappelli , A , Carling , U , Chan , B K Y , Chang , D H , choi , J , Font , J C , Crawford , M , Croagh , D , Cugat , E , Davis , R , De Boo , D W , De Cobelli , F , De Wispelaere , J F , van Delden , O M , Delle , M , Detry , O , Díaz-Nieto , R , Dili , A , Erdmann , J I , Fisher , O , Fondevila , C , Fretland , Borobia , F G , Gelabert , A , Gérard , L , Giuliante , F , Gobardhan , P D , Gómez , F , Grünberger , T , Grünhagen , 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 G , Ben , S L , 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 , U , Ryan , S , Sallemi , C , Moragues , J S , Sandström , P , Sarriá , L , Schnitzbauer , A , Serenari , M , Serrablo , A , Smits , M L J , Sparrelid , E , Spüntrup , 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 J , Binkert , C A , Bemelmans , M H A , van der Leij , C , Schadde , E & van Dam , R M 2022 , ' 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 ' , Ca
- Publication Year :
- 2022
-
Abstract
- 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. Trial Registration: Clinicaltrials.gov: NCT04272931 (February 17, 2020). Toestingonline.nl: NL71535.068.19 (September 20, 2019).
Details
- Database :
- OAIster
- Journal :
- Korenblik , R , Olij , B , Aldrighetti , L A , Hilal , M A , Ahle , M , Arslan , B , van Baardewijk , L J , Baclija , I , Bent , C , Bertrand , C L , Björnsson , B , de Boer , M T , de Boer , S W , Bokkers , R P H , Rinkes , I H M B , Breitenstein , S , Bruijnen , R C G , Bruners , P , Büchler , M W , Camacho , J C , Cappelli , A , Carling , U , Chan , B K Y , Chang , D H , choi , J , Font , J C , Crawford , M , Croagh , D , Cugat , E , Davis , R , De Boo , D W , De Cobelli , F , De Wispelaere , J F , van Delden , O M , Delle , M , Detry , O , Díaz-Nieto , R , Dili , A , Erdmann , J I , Fisher , O , Fondevila , C , Fretland , Borobia , F G , Gelabert , A , Gérard , L , Giuliante , F , Gobardhan , P D , Gómez , F , Grünberger , T , Grünhagen , 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 G , Ben , S L , 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 , U , Ryan , S , Sallemi , C , Moragues , J S , Sandström , P , Sarriá , L , Schnitzbauer , A , Serenari , M , Serrablo , A , Smits , M L J , Sparrelid , E , Spüntrup , 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 J , Binkert , C A , Bemelmans , M H A , van der Leij , C , Schadde , E & van Dam , R M 2022 , ' 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 ' , Ca
- Notes :
- application/pdf, English
- Publication Type :
- Electronic Resource
- Accession number :
- edsoai.on1346347807
- Document Type :
- Electronic Resource