التفاصيل البيبلوغرافية
| العنوان: |
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 |
| المؤلفون: |
Korenblik, R, Olij, B, Aldrighetti, L A, Hilal, M Abu, 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 Borel, 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 Codina, 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, Å, Borobia, F Garcia, 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 Lopez, 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 Sampere, 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 |
| المساهمون: |
Zorgeenheid Orthopaedie Medisch, MS Radiologie, MS CGO, Regenerative Medicine and Stem Cells, Cancer, Other research (not in main researchprogram), Experimentele Afdeling Longziekten |
| سنة النشر: |
2022 |
| مصطلحات موضوعية: |
Accreditation, Embolization, Therapeutic/methods, Hepatectomy/methods, Hepatic Veins/pathology, Hepatomegaly, Humans, Hypertrophy/etiology, Liver Neoplasms/diagnostic imaging, Liver/surgery, Multicenter Studies as Topic, Portal Vein/pathology, Prospective Studies, Treatment Outcome, Portal vein embolization (PVE), Colorectal cancer liver metastases (CRLM), Liver hypertrophy, Future liver remnant (FLR), Combined portal- and hepatic vein embolization (PVE/HVE), Hepatic vein embolization (HVE), Cardiology and Cardiovascular Medicine, Radiology Nuclear Medicine and imaging, Journal Article |
| الوصف: |
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). |
| نوع الوثيقة: |
article in journal/newspaper |
| وصف الملف: |
application/pdf |
| اللغة: |
English |
| تدمد: |
0174-1551 |
| العلاقة: |
https://dspace.library.uu.nl/handle/1874/447923Test |
| الإتاحة: |
https://dspace.library.uu.nl/handle/1874/447923Test |
| حقوق: |
info:eu-repo/semantics/OpenAccess |
| رقم الانضمام: |
edsbas.F5F0FAAC |
| قاعدة البيانات: |
BASE |
