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BestFLR Trial: Liver Regeneration at CT before Major Hepatectomies for Liver Cancer-A Randomized Controlled Trial Comparing Portal Vein Embolization with N-Butyl-Cyanoacrylate Plus Iodized Oil versus Polyvinyl Alcohol Particles Plus Coils.
Luz, José Hugo Mendes; Veloso Gomes, Filipe; Costa, Nuno Vasco; Vasco, Inês; Coimbra, Elia; Luz, Paula Mendes; Marques, Hugo Pinto; Coelho, João Santos; Mega, Raquel Maria Alexandre; Ribeiro, Vasco Nuno Torres Vouga; da Costa Lamelas, Jorge Tiago Rodrigues; de Sampaio Nunes E Sobral, Maria Mafalda; da Silva, Sílvia Raquel Gomes; de Teixeira Carrelha, Ana Sofia; Rodrigues, Susana Cristina Cardoso; de Figueiredo, António Augusto Ferreira Pinto; Santos, Margarida Varela; Bilhim, Tiago.
Affiliation
  • Luz JHM; From the Interventional Radiology Unit (J.H.M.L., F.V.G., N.V.C., I.V., E.C., T.B.), Hepato-Biliary-Pancreatic and Transplantation Center (H.P.M., J.S.C., R.M.A.M., V.N.T.V.R., J.T.R.d.C.L., M.M.d.S.N.e.S., S.R.G.d.S., A.S.d.T.C., S.C.C.R.), and Department of Pathology (A.A.F.P.d.F., M.V.S.), Hospit
  • Veloso Gomes F; From the Interventional Radiology Unit (J.H.M.L., F.V.G., N.V.C., I.V., E.C., T.B.), Hepato-Biliary-Pancreatic and Transplantation Center (H.P.M., J.S.C., R.M.A.M., V.N.T.V.R., J.T.R.d.C.L., M.M.d.S.N.e.S., S.R.G.d.S., A.S.d.T.C., S.C.C.R.), and Department of Pathology (A.A.F.P.d.F., M.V.S.), Hospit
  • Costa NV; From the Interventional Radiology Unit (J.H.M.L., F.V.G., N.V.C., I.V., E.C., T.B.), Hepato-Biliary-Pancreatic and Transplantation Center (H.P.M., J.S.C., R.M.A.M., V.N.T.V.R., J.T.R.d.C.L., M.M.d.S.N.e.S., S.R.G.d.S., A.S.d.T.C., S.C.C.R.), and Department of Pathology (A.A.F.P.d.F., M.V.S.), Hospit
  • Vasco I; From the Interventional Radiology Unit (J.H.M.L., F.V.G., N.V.C., I.V., E.C., T.B.), Hepato-Biliary-Pancreatic and Transplantation Center (H.P.M., J.S.C., R.M.A.M., V.N.T.V.R., J.T.R.d.C.L., M.M.d.S.N.e.S., S.R.G.d.S., A.S.d.T.C., S.C.C.R.), and Department of Pathology (A.A.F.P.d.F., M.V.S.), Hospit
  • Coimbra E; From the Interventional Radiology Unit (J.H.M.L., F.V.G., N.V.C., I.V., E.C., T.B.), Hepato-Biliary-Pancreatic and Transplantation Center (H.P.M., J.S.C., R.M.A.M., V.N.T.V.R., J.T.R.d.C.L., M.M.d.S.N.e.S., S.R.G.d.S., A.S.d.T.C., S.C.C.R.), and Department of Pathology (A.A.F.P.d.F., M.V.S.), Hospit
  • Luz PM; From the Interventional Radiology Unit (J.H.M.L., F.V.G., N.V.C., I.V., E.C., T.B.), Hepato-Biliary-Pancreatic and Transplantation Center (H.P.M., J.S.C., R.M.A.M., V.N.T.V.R., J.T.R.d.C.L., M.M.d.S.N.e.S., S.R.G.d.S., A.S.d.T.C., S.C.C.R.), and Department of Pathology (A.A.F.P.d.F., M.V.S.), Hospit
  • Marques HP; From the Interventional Radiology Unit (J.H.M.L., F.V.G., N.V.C., I.V., E.C., T.B.), Hepato-Biliary-Pancreatic and Transplantation Center (H.P.M., J.S.C., R.M.A.M., V.N.T.V.R., J.T.R.d.C.L., M.M.d.S.N.e.S., S.R.G.d.S., A.S.d.T.C., S.C.C.R.), and Department of Pathology (A.A.F.P.d.F., M.V.S.), Hospit
  • Coelho JS; From the Interventional Radiology Unit (J.H.M.L., F.V.G., N.V.C., I.V., E.C., T.B.), Hepato-Biliary-Pancreatic and Transplantation Center (H.P.M., J.S.C., R.M.A.M., V.N.T.V.R., J.T.R.d.C.L., M.M.d.S.N.e.S., S.R.G.d.S., A.S.d.T.C., S.C.C.R.), and Department of Pathology (A.A.F.P.d.F., M.V.S.), Hospit
  • Mega RMA; From the Interventional Radiology Unit (J.H.M.L., F.V.G., N.V.C., I.V., E.C., T.B.), Hepato-Biliary-Pancreatic and Transplantation Center (H.P.M., J.S.C., R.M.A.M., V.N.T.V.R., J.T.R.d.C.L., M.M.d.S.N.e.S., S.R.G.d.S., A.S.d.T.C., S.C.C.R.), and Department of Pathology (A.A.F.P.d.F., M.V.S.), Hospit
  • Ribeiro VNTV; From the Interventional Radiology Unit (J.H.M.L., F.V.G., N.V.C., I.V., E.C., T.B.), Hepato-Biliary-Pancreatic and Transplantation Center (H.P.M., J.S.C., R.M.A.M., V.N.T.V.R., J.T.R.d.C.L., M.M.d.S.N.e.S., S.R.G.d.S., A.S.d.T.C., S.C.C.R.), and Department of Pathology (A.A.F.P.d.F., M.V.S.), Hospit
  • da Costa Lamelas JTR; From the Interventional Radiology Unit (J.H.M.L., F.V.G., N.V.C., I.V., E.C., T.B.), Hepato-Biliary-Pancreatic and Transplantation Center (H.P.M., J.S.C., R.M.A.M., V.N.T.V.R., J.T.R.d.C.L., M.M.d.S.N.e.S., S.R.G.d.S., A.S.d.T.C., S.C.C.R.), and Department of Pathology (A.A.F.P.d.F., M.V.S.), Hospit
  • de Sampaio Nunes E Sobral MM; From the Interventional Radiology Unit (J.H.M.L., F.V.G., N.V.C., I.V., E.C., T.B.), Hepato-Biliary-Pancreatic and Transplantation Center (H.P.M., J.S.C., R.M.A.M., V.N.T.V.R., J.T.R.d.C.L., M.M.d.S.N.e.S., S.R.G.d.S., A.S.d.T.C., S.C.C.R.), and Department of Pathology (A.A.F.P.d.F., M.V.S.), Hospit
  • da Silva SRG; From the Interventional Radiology Unit (J.H.M.L., F.V.G., N.V.C., I.V., E.C., T.B.), Hepato-Biliary-Pancreatic and Transplantation Center (H.P.M., J.S.C., R.M.A.M., V.N.T.V.R., J.T.R.d.C.L., M.M.d.S.N.e.S., S.R.G.d.S., A.S.d.T.C., S.C.C.R.), and Department of Pathology (A.A.F.P.d.F., M.V.S.), Hospit
  • de Teixeira Carrelha AS; From the Interventional Radiology Unit (J.H.M.L., F.V.G., N.V.C., I.V., E.C., T.B.), Hepato-Biliary-Pancreatic and Transplantation Center (H.P.M., J.S.C., R.M.A.M., V.N.T.V.R., J.T.R.d.C.L., M.M.d.S.N.e.S., S.R.G.d.S., A.S.d.T.C., S.C.C.R.), and Department of Pathology (A.A.F.P.d.F., M.V.S.), Hospit
  • Rodrigues SCC; From the Interventional Radiology Unit (J.H.M.L., F.V.G., N.V.C., I.V., E.C., T.B.), Hepato-Biliary-Pancreatic and Transplantation Center (H.P.M., J.S.C., R.M.A.M., V.N.T.V.R., J.T.R.d.C.L., M.M.d.S.N.e.S., S.R.G.d.S., A.S.d.T.C., S.C.C.R.), and Department of Pathology (A.A.F.P.d.F., M.V.S.), Hospit
  • de Figueiredo AAFP; From the Interventional Radiology Unit (J.H.M.L., F.V.G., N.V.C., I.V., E.C., T.B.), Hepato-Biliary-Pancreatic and Transplantation Center (H.P.M., J.S.C., R.M.A.M., V.N.T.V.R., J.T.R.d.C.L., M.M.d.S.N.e.S., S.R.G.d.S., A.S.d.T.C., S.C.C.R.), and Department of Pathology (A.A.F.P.d.F., M.V.S.), Hospit
  • Santos MV; From the Interventional Radiology Unit (J.H.M.L., F.V.G., N.V.C., I.V., E.C., T.B.), Hepato-Biliary-Pancreatic and Transplantation Center (H.P.M., J.S.C., R.M.A.M., V.N.T.V.R., J.T.R.d.C.L., M.M.d.S.N.e.S., S.R.G.d.S., A.S.d.T.C., S.C.C.R.), and Department of Pathology (A.A.F.P.d.F., M.V.S.), Hospit
  • Bilhim T; From the Interventional Radiology Unit (J.H.M.L., F.V.G., N.V.C., I.V., E.C., T.B.), Hepato-Biliary-Pancreatic and Transplantation Center (H.P.M., J.S.C., R.M.A.M., V.N.T.V.R., J.T.R.d.C.L., M.M.d.S.N.e.S., S.R.G.d.S., A.S.d.T.C., S.C.C.R.), and Department of Pathology (A.A.F.P.d.F., M.V.S.), Hospit
Radiology ; 299(3): 715-724, 2021 06.
Article de En | MEDLINE | ID: mdl-33825512
ABSTRACT
Background In patients with liver cancer, portal vein embolization (PVE) is recommended to promote liver growth before major hepatectomies. However, the optimal embolization strategy has not been established. Purpose To compare liver regeneration as seen at CT in participants with liver cancer, before major hepatectomies, with N-butyl-cyanoacrylate (NBCA) plus iodized oil versus standard polyvinyl alcohol (PVA) particles plus coils, for PVE. Materials and Methods In this single-center, prospective, randomized controlled trial (Best Future Liver Remnant, or BestFLR, trial; International Standard Randomized Controlled Trial Number 16062796), PVE with NBCA plus iodized oil was compared with standard PVE with PVA particles plus coils in participants with liver cancer. Participant recruitment started in November 2017 and ended in March 2020. Participants were randomly assigned to undergo PVE with PVA particles plus coils or PVE with NBCA plus iodized oil. The primary end point was liver growth assessed with CT 14 days and 28 days after PVE. Secondary outcomes included posthepatectomy liver failure, surgical complications, and length of intensive care treatment and hospital stay. The Mann-Whitney U test was used to compare continuous outcomes according to PVE material, whereas the Χ2 test or Fisher exact test was used for categoric variables. Results Sixty participants (mean age, 61 years ± 11 [standard deviation]; 32 men) were assigned to the PVA particles plus coils group (n = 30) or to the NBCA plus iodized oil group (n = 30). Interim analysis revealed faster and superior liver hypertrophy for the NBCA plus iodized oil group versus the PVA particles plus coils group 14 days and 28 days after PVE (absolute hypertrophy of 46% vs 30% [P < .001] and 57% vs 37% [P < .001], respectively). Liver growth for the proposed hepatectomy was achieved in 87% of participants (26 of 30) in the NBCA plus iodized oil group versus 53% of participants (16 of 30) in the PVA particles plus coils group (P = .008) 14 days after PVE. Liver failure occurred in 13% of participants (three of 24) in the NBCA plus iodized oil group and in 27% of participants (six of 22) in the PVA particles plus coils group (P = .27). Conclusion Portal vein embolization with N-butyl-cyanoacrylate plus iodized oil produced greater and faster liver growth as seen at CT in participants with liver cancer, compared with portal vein embolization with polyvinyl alcohol particles plus coils, allowing for earlier surgical intervention. © RSNA, 2021 Online supplemental material is available for this article. See also the editorial by Arellano in this issue.
Sujet(s)

Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Tomodensitométrie / Embolisation thérapeutique / Tumeurs du foie / Régénération hépatique Type d'étude: Clinical_trials / Observational_studies Limites: Female / Humans / Male / Middle aged Langue: En Journal: Radiology Année: 2021 Type de document: Article

Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Tomodensitométrie / Embolisation thérapeutique / Tumeurs du foie / Régénération hépatique Type d'étude: Clinical_trials / Observational_studies Limites: Female / Humans / Male / Middle aged Langue: En Journal: Radiology Année: 2021 Type de document: Article