@article{8a1a3e73b19449aaba1604dc39499f66,
title = "Complication Rate of Percutaneous Liver Biopsies Among Persons With Advanced Chronic Liver Disease in the HALT-C Trial",
abstract = "Background & Aims: Although percutaneous liver biopsy is a standard diagnostic procedure, it has drawbacks, including risk of serious complications. It is not known whether persons with advanced chronic liver disease have a greater risk of complications from liver biopsy than patients with more mild, chronic liver disease. The safety and complications of liver biopsy were examined in patients with hepatitis C-related bridging fibrosis or cirrhosis who were enrolled in the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis trial. Methods: Standard case report forms from 2740 liver biopsies performed at 10 study sites between 2000 and 2006 were reviewed for serious adverse events, together with information from questionnaires completed by investigators about details of biopsy techniques used at each hospital. Results: There were 29 serious adverse events (1.1%); the most common was bleeding (16 cases; 0.6%). There were no biopsy-related deaths. The bleeding rate was higher among patients with platelet counts of 60,000/mm3 or less and among those with an international normalized ratio of 1.3 or greater, although none of the patients with an international normalized ratio greater than 1.5 bled. Excluding subjects with a platelet count of 60,000/mm3 or less would have reduced the bleeding rate by 25% (4 of 16), eliminating only 2.8% (77 of 2740) of biopsies. Operator experience, the type of needle used, or the performance of the biopsy under ultrasound guidance did not influence the frequencies of adverse events. Conclusions: Approximately 0.5% of persons with hepatitis C and advanced fibrosis experienced potentially serious bleeding after liver biopsy; risk increased significantly in patients with platelet counts of 60,000/mm3 or less.",
keywords = "Adverse Event, Bleeding, Complications, INR, Liver Biopsy, Platelet Count, Serious Adverse Events",
author = "Seeff, {Leonard B.} and Everson, {Gregory T.} and Morgan, {Timothy R.} and Curto, {Teresa M.} and Lee, {William M.} and Ghany, {Marc G.} and Shiffman, {Mitchell L.} and Fontana, {Robert J.} and {Di Bisceglie}, {Adrian M.} and Bonkovsky, {Herbert L.} and Dienstag, {Jules L.}",
note = "Funding Information: The following people were members of the writing group and contributed equally to the analysis and writing of this manuscript: Leonard Seeff, Gregory Everson, Timothy Morgan, Teresa Curto, William Lee, and Marc Ghany. In addition to the authors of this manuscript, the following individuals were instrumental in the planning, conduct, and/or care of patients enrolled in this study at each of the participating institutions as follows: University of Massachusetts Medical Center , Worcester, MA: (contract N01-DK-9-2326) Gyongyi Szabo, MD, Barbara F. Banner, MD, Maureen Cormier, RN, and Donna Giansiracusa, RN; University of Connecticut Health Center , Farmington, CT: (grant M01RR-06192 ) Gloria Borders, RN, and Michelle Kelley, RN, ANP; Saint Louis University School of Medicine , St Louis, MO: (contract N01-DK-9-2324) Bruce Bacon, MD, Brent Neuschwander-Tetri, MD, Elizabeth M. Brunt, MD, and Debra King, RN; Massachusetts General Hospital , Boston, MA: (contract N01-DK-9-2319, grant M01RR-01066 ; grant 1 UL1 RR025758-01 , Harvard Clinical and Translational Science Center ) Raymond T. Chung, MD, Andrea E. Reid, MD, Atul K. Bhan, MD, Wallis A. Molchen, and Cara C. Gooch; University of Colorado Denver, School of Medicine , Aurora, CO: (contract N01-DK-9-2327, grant M01RR-00051 , grant 1 UL1 RR 025780-01 ) Thomas Trouillot, MD, Marcelo Kugelmas, MD, S. Russell Nash, MD, Jennifer DeSanto, RN, and Carol McKinley, RN; University of California–Irvine , Irvine, CA: (contract N01-DK-9-2320, grant M01RR-00827 ) John C. Hoefs, MD, John R. Craig, MD, M. Mazen Jamal, MD, MPH, Muhammad Sheikh, MD, and Choon Park, RN; University of Texas Southwestern Medical Center , Dallas, TX: (contract N01-DK-9-2321, grant M01RR-00633 , grant 1 UL1 RR024982-01 , North and Central Texas Clinical and Translational Science Initiative ) Thomas E. Rogers, MD, Peter F. Malet, MD, Janel Shelton, Nicole Crowder, LVN, Rivka Elbein, RN, BSN, and Nancy Liston, MPH; University of Southern California , Los Angeles, CA: (contract N01-DK-9-2325, grant M01RR-00043 ) Karen L. Lindsay, MD, MMM, Jeffrey A. Kahn, MD, Sugantha Govindarajan, MD, Carol B. Jones, RN, and Susan L. Milstein, RN; University of Michigan Medical Center , Ann Arbor, MI: (contract N01-DK-9-2323, grant M01RR-00042 , grant 1 UL1 RR024986 , Michigan Center for Clinical and Health Research ) Anna S. Lok, MD, Joel K. Greenson, MD, Pamela A. Richtmyer, LPN, CCRC, and R. Tess Bonham, BS; Virginia Commonwealth University Health System , Richmond, VA: (contract N01-DK-9-2322, grant M01RR-00065 ) Richard K. Sterling, MD, MSc, Melissa J. Contos, MD, A. Scott Mills, MD, Charlotte Hofmann, RN, and Paula Smith, RN; Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health , Bethesda, MD: T. Jake Liang, MD, David Kleiner, MD, PhD, Yoon Park, RN, Elenita Rivera, RN, and Vanessa Haynes-Williams, RN; National Institute of Diabetes and Digestive and Kidney Diseases, Division of Digestive Diseases and Nutrition , Bethesda, MD: James E. Everhart, MD, Patricia R. Robuck, PhD, Jay H. Hoofnagle, MD, and Elizabeth C. Wright, PhD; University of Washington , Seattle, WA: (contract N01-DK-9-2318) Chihiro Morishima, MD, David R. Gretch, MD, PhD, Minjun Chung Apodaca, BS, ASCP, Rohit Shankar, BC, ASCP, and Natalia Antonov, MEd; New England Research Institutes , Watertown, MA: (contract N01-DK-9-2328) Kristin K. Snow, MSc, ScD, and Margaret C. Bell, MS, MPH; Armed Forces Institute of Pathology , Washington, DC: Zachary D. Goodman, MD, PhD, Fanny Monge, and Michelle Parks; Data and Safety Monitoring Board Members: (Chair) Gary L. Davis, MD, Guadalupe Garcia-Tsao, MD, Michael Kutner, PhD, Stanley M. Lemon, MD, and Robert P. Perrillo, MD. Dr Bonkovsky's current address is Carolinas Medical Center, Charlotte, NC. ",
year = "2010",
month = oct,
doi = "10.1016/j.cgh.2010.03.025",
language = "English (US)",
volume = "8",
pages = "877--883",
journal = "Clinical Gastroenterology and Hepatology",
issn = "1542-3565",
publisher = "W.B. Saunders Ltd",
number = "10",
}