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Autologous Blood Patch Injection versus Hydrogel Plug in CT-guided Lung Biopsy: A Prospective Randomized Trial.
Maybody, Majid; Muallem, Nadim; Brown, Karen T; Moskowitz, Chaya S; Hsu, Meier; Zenobi, Christina L; Jihad, Marwah; Getrajdman, George I; Sofocleous, Constantinos T; Erinjeri, Joseph P; Covey, Anne M; Brody, Lynn A; Yarmohammadi, Hooman; Deipolyi, Amy R; Bryce, Yolanda; Alago, William; Siegelbaum, Robert H; Durack, Jeremy C; Gonzalez-Aguirre, Adrian J; Ziv, Etay; Boas, F Edward; Solomon, Stephen B.
Afiliação
  • Maybody M; From the Departments of Radiology (M.M., N.M., K.T.B., C.L.Z., M.J., C.I.G., C.T.S., J.P.E., A.M.C., L.A.B., H.Y., A.R.D., Y.B., W.A., R.H.S., J.C.D., A.J.G., E.Z., F.E.B., S.B.S.) and Epidemiology and Biostatistics (C.S.M., M.H.), Memorial Sloan Kettering Cancer Center, 1275 York Ave, M276C, New Yo
  • Muallem N; From the Departments of Radiology (M.M., N.M., K.T.B., C.L.Z., M.J., C.I.G., C.T.S., J.P.E., A.M.C., L.A.B., H.Y., A.R.D., Y.B., W.A., R.H.S., J.C.D., A.J.G., E.Z., F.E.B., S.B.S.) and Epidemiology and Biostatistics (C.S.M., M.H.), Memorial Sloan Kettering Cancer Center, 1275 York Ave, M276C, New Yo
  • Brown KT; From the Departments of Radiology (M.M., N.M., K.T.B., C.L.Z., M.J., C.I.G., C.T.S., J.P.E., A.M.C., L.A.B., H.Y., A.R.D., Y.B., W.A., R.H.S., J.C.D., A.J.G., E.Z., F.E.B., S.B.S.) and Epidemiology and Biostatistics (C.S.M., M.H.), Memorial Sloan Kettering Cancer Center, 1275 York Ave, M276C, New Yo
  • Moskowitz CS; From the Departments of Radiology (M.M., N.M., K.T.B., C.L.Z., M.J., C.I.G., C.T.S., J.P.E., A.M.C., L.A.B., H.Y., A.R.D., Y.B., W.A., R.H.S., J.C.D., A.J.G., E.Z., F.E.B., S.B.S.) and Epidemiology and Biostatistics (C.S.M., M.H.), Memorial Sloan Kettering Cancer Center, 1275 York Ave, M276C, New Yo
  • Hsu M; From the Departments of Radiology (M.M., N.M., K.T.B., C.L.Z., M.J., C.I.G., C.T.S., J.P.E., A.M.C., L.A.B., H.Y., A.R.D., Y.B., W.A., R.H.S., J.C.D., A.J.G., E.Z., F.E.B., S.B.S.) and Epidemiology and Biostatistics (C.S.M., M.H.), Memorial Sloan Kettering Cancer Center, 1275 York Ave, M276C, New Yo
  • Zenobi CL; From the Departments of Radiology (M.M., N.M., K.T.B., C.L.Z., M.J., C.I.G., C.T.S., J.P.E., A.M.C., L.A.B., H.Y., A.R.D., Y.B., W.A., R.H.S., J.C.D., A.J.G., E.Z., F.E.B., S.B.S.) and Epidemiology and Biostatistics (C.S.M., M.H.), Memorial Sloan Kettering Cancer Center, 1275 York Ave, M276C, New Yo
  • Jihad M; From the Departments of Radiology (M.M., N.M., K.T.B., C.L.Z., M.J., C.I.G., C.T.S., J.P.E., A.M.C., L.A.B., H.Y., A.R.D., Y.B., W.A., R.H.S., J.C.D., A.J.G., E.Z., F.E.B., S.B.S.) and Epidemiology and Biostatistics (C.S.M., M.H.), Memorial Sloan Kettering Cancer Center, 1275 York Ave, M276C, New Yo
  • Getrajdman GI; From the Departments of Radiology (M.M., N.M., K.T.B., C.L.Z., M.J., C.I.G., C.T.S., J.P.E., A.M.C., L.A.B., H.Y., A.R.D., Y.B., W.A., R.H.S., J.C.D., A.J.G., E.Z., F.E.B., S.B.S.) and Epidemiology and Biostatistics (C.S.M., M.H.), Memorial Sloan Kettering Cancer Center, 1275 York Ave, M276C, New Yo
  • Sofocleous CT; From the Departments of Radiology (M.M., N.M., K.T.B., C.L.Z., M.J., C.I.G., C.T.S., J.P.E., A.M.C., L.A.B., H.Y., A.R.D., Y.B., W.A., R.H.S., J.C.D., A.J.G., E.Z., F.E.B., S.B.S.) and Epidemiology and Biostatistics (C.S.M., M.H.), Memorial Sloan Kettering Cancer Center, 1275 York Ave, M276C, New Yo
  • Erinjeri JP; From the Departments of Radiology (M.M., N.M., K.T.B., C.L.Z., M.J., C.I.G., C.T.S., J.P.E., A.M.C., L.A.B., H.Y., A.R.D., Y.B., W.A., R.H.S., J.C.D., A.J.G., E.Z., F.E.B., S.B.S.) and Epidemiology and Biostatistics (C.S.M., M.H.), Memorial Sloan Kettering Cancer Center, 1275 York Ave, M276C, New Yo
  • Covey AM; From the Departments of Radiology (M.M., N.M., K.T.B., C.L.Z., M.J., C.I.G., C.T.S., J.P.E., A.M.C., L.A.B., H.Y., A.R.D., Y.B., W.A., R.H.S., J.C.D., A.J.G., E.Z., F.E.B., S.B.S.) and Epidemiology and Biostatistics (C.S.M., M.H.), Memorial Sloan Kettering Cancer Center, 1275 York Ave, M276C, New Yo
  • Brody LA; From the Departments of Radiology (M.M., N.M., K.T.B., C.L.Z., M.J., C.I.G., C.T.S., J.P.E., A.M.C., L.A.B., H.Y., A.R.D., Y.B., W.A., R.H.S., J.C.D., A.J.G., E.Z., F.E.B., S.B.S.) and Epidemiology and Biostatistics (C.S.M., M.H.), Memorial Sloan Kettering Cancer Center, 1275 York Ave, M276C, New Yo
  • Yarmohammadi H; From the Departments of Radiology (M.M., N.M., K.T.B., C.L.Z., M.J., C.I.G., C.T.S., J.P.E., A.M.C., L.A.B., H.Y., A.R.D., Y.B., W.A., R.H.S., J.C.D., A.J.G., E.Z., F.E.B., S.B.S.) and Epidemiology and Biostatistics (C.S.M., M.H.), Memorial Sloan Kettering Cancer Center, 1275 York Ave, M276C, New Yo
  • Deipolyi AR; From the Departments of Radiology (M.M., N.M., K.T.B., C.L.Z., M.J., C.I.G., C.T.S., J.P.E., A.M.C., L.A.B., H.Y., A.R.D., Y.B., W.A., R.H.S., J.C.D., A.J.G., E.Z., F.E.B., S.B.S.) and Epidemiology and Biostatistics (C.S.M., M.H.), Memorial Sloan Kettering Cancer Center, 1275 York Ave, M276C, New Yo
  • Bryce Y; From the Departments of Radiology (M.M., N.M., K.T.B., C.L.Z., M.J., C.I.G., C.T.S., J.P.E., A.M.C., L.A.B., H.Y., A.R.D., Y.B., W.A., R.H.S., J.C.D., A.J.G., E.Z., F.E.B., S.B.S.) and Epidemiology and Biostatistics (C.S.M., M.H.), Memorial Sloan Kettering Cancer Center, 1275 York Ave, M276C, New Yo
  • Alago W; From the Departments of Radiology (M.M., N.M., K.T.B., C.L.Z., M.J., C.I.G., C.T.S., J.P.E., A.M.C., L.A.B., H.Y., A.R.D., Y.B., W.A., R.H.S., J.C.D., A.J.G., E.Z., F.E.B., S.B.S.) and Epidemiology and Biostatistics (C.S.M., M.H.), Memorial Sloan Kettering Cancer Center, 1275 York Ave, M276C, New Yo
  • Siegelbaum RH; From the Departments of Radiology (M.M., N.M., K.T.B., C.L.Z., M.J., C.I.G., C.T.S., J.P.E., A.M.C., L.A.B., H.Y., A.R.D., Y.B., W.A., R.H.S., J.C.D., A.J.G., E.Z., F.E.B., S.B.S.) and Epidemiology and Biostatistics (C.S.M., M.H.), Memorial Sloan Kettering Cancer Center, 1275 York Ave, M276C, New Yo
  • Durack JC; From the Departments of Radiology (M.M., N.M., K.T.B., C.L.Z., M.J., C.I.G., C.T.S., J.P.E., A.M.C., L.A.B., H.Y., A.R.D., Y.B., W.A., R.H.S., J.C.D., A.J.G., E.Z., F.E.B., S.B.S.) and Epidemiology and Biostatistics (C.S.M., M.H.), Memorial Sloan Kettering Cancer Center, 1275 York Ave, M276C, New Yo
  • Gonzalez-Aguirre AJ; From the Departments of Radiology (M.M., N.M., K.T.B., C.L.Z., M.J., C.I.G., C.T.S., J.P.E., A.M.C., L.A.B., H.Y., A.R.D., Y.B., W.A., R.H.S., J.C.D., A.J.G., E.Z., F.E.B., S.B.S.) and Epidemiology and Biostatistics (C.S.M., M.H.), Memorial Sloan Kettering Cancer Center, 1275 York Ave, M276C, New Yo
  • Ziv E; From the Departments of Radiology (M.M., N.M., K.T.B., C.L.Z., M.J., C.I.G., C.T.S., J.P.E., A.M.C., L.A.B., H.Y., A.R.D., Y.B., W.A., R.H.S., J.C.D., A.J.G., E.Z., F.E.B., S.B.S.) and Epidemiology and Biostatistics (C.S.M., M.H.), Memorial Sloan Kettering Cancer Center, 1275 York Ave, M276C, New Yo
  • Boas FE; From the Departments of Radiology (M.M., N.M., K.T.B., C.L.Z., M.J., C.I.G., C.T.S., J.P.E., A.M.C., L.A.B., H.Y., A.R.D., Y.B., W.A., R.H.S., J.C.D., A.J.G., E.Z., F.E.B., S.B.S.) and Epidemiology and Biostatistics (C.S.M., M.H.), Memorial Sloan Kettering Cancer Center, 1275 York Ave, M276C, New Yo
  • Solomon SB; From the Departments of Radiology (M.M., N.M., K.T.B., C.L.Z., M.J., C.I.G., C.T.S., J.P.E., A.M.C., L.A.B., H.Y., A.R.D., Y.B., W.A., R.H.S., J.C.D., A.J.G., E.Z., F.E.B., S.B.S.) and Epidemiology and Biostatistics (C.S.M., M.H.), Memorial Sloan Kettering Cancer Center, 1275 York Ave, M276C, New Yo
Radiology ; 290(2): 547-554, 2019 02.
Article em En | MEDLINE | ID: mdl-30480487
ABSTRACT
Purpose To compare the effect of autologous blood patch injection (ABPI) with that of a hydrogel plug on the rate of pneumothorax at CT-guided percutaneous lung biopsy. Materials and Methods In this prospective randomized controlled trial ( https//ClinicalTrials.gov , NCT02224924), a noninferiority design was used for ABPI, with a 10% noninferiority margin when compared with the hydrogel plug, with the primary outcome of pneumothorax rate within 2 hours of biopsy. A type I error rate of 0.05 and 90% power were specified with a target study population of 552 participants (276 in each arm). From October 2014 to February 2017, all potential study participants referred for CT-guided lung biopsy (n = 2052) were assessed for enrollment. Results The data safety monitoring board recommended the trial be closed to accrual after an interim analysis met prespecified criteria for early stopping based on noninferiority. The final study group consisted of 453 participants who were randomly assigned to the ABPI (n = 226) or hydrogel plug (n = 227) arms. Of these, 407 underwent lung biopsy. Pneumothorax rates within 2 hours of biopsy were 21% (42 of 199) and 29% (60 of 208); chest tube rates were 9% (18 of 199) and 13% (27 of 208); and delayed pneumothorax rates within 2 weeks after biopsy were 1.4% (three of 199) and 1.5% (three of 208) in the ABPI and hydrogel plug arms, respectively. Conclusion Autologous blood patch injection is noninferior to a hydrogel plug regarding the rate of pneumothorax after CT-guided percutaneous lung biopsy. © RSNA, 2018 Online supplemental material is available for this article.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Pneumotórax / Terapia Biológica / Hidrogéis / Biópsia Guiada por Imagem / Pulmão Tipo de estudo: Clinical_trials / Etiology_studies / Observational_studies / Risk_factors_studies Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Radiology Ano de publicação: 2019 Tipo de documento: Article
Texto completo
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Pneumotórax / Terapia Biológica / Hidrogéis / Biópsia Guiada por Imagem / Pulmão Tipo de estudo: Clinical_trials / Etiology_studies / Observational_studies / Risk_factors_studies Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Radiology Ano de publicação: 2019 Tipo de documento: Article