Original article—liver, pancreas, and biliary tractComplication Rate of Percutaneous Liver Biopsies Among Persons With Advanced Chronic Liver Disease in the HALT-C Trial
Section snippets
Methods
The HALT-C trial was conducted at 10 clinical sites between August 2000 and July 2006.17 Inclusion criteria were age older than 18 years, compensated chronic hepatitis C, and nonresponse to prior treatment with interferon with or without ribavirin. Exclusion criteria were a Child–Turcotte–Pugh score of 7 or greater, platelet count less than 50,000/mm3, hemoglobin level less than 11 g/dL, serum creatinine level greater than 1.5 mg/dL, α-fetoprotein level greater than 200 ng/mL, a mass on imaging
Preparations for and Techniques of the Liver Biopsies
Questionnaire responses indicated that biopsies were performed predominantly by participating HALT-C investigators, all experienced hepatologists, but an estimated 20% were performed by supervised gastroenterology/hepatology fellows, and, occasionally, by interventional radiologists. Approximately 90% were outpatient procedures. Most (80%) used bedside ultrasound guidance, and all included anesthetizing the subcutaneous tissue and liver capsule. In 60%, conscious sedation with short-acting
Discussion
Deciding to perform a liver biopsy must take into account the value of information hoped to be gained relative to the risk of complications. Hepatic histology helps define liver disease etiology and severity and aids clinicians in management. Liver biopsy accordingly has been a cornerstone in evaluating persons with liver disease.1 However, it is invasive, and potentially associated with serious complications that rarely may be life-threatening.6, 8, 9, 10, 11, 12, 13, 14, 15
In the HALT-C trial,
Acknowledgments
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:
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Conflicts of interest These authors disclose the following financial relationships with Hoffmann-La Roche, Inc: Gregory Everson is a consultant and receives research support; Timothy Morgan is a consultant, on the speaker's bureau, and receives research support; William Lee receives research support; Mitchell Shiffman is a consultant, on the speaker's bureau and advisor meetings, and receives research support; Robert Fontana is on the speaker's bureau; Adrian Di Bisceglie is a consultant and receives research support; and Herbert Bonkovsky receives research support. The remaining authors disclose no conflicts.
Funding This study was supported by the National Institute of Diabetes & Digestive & Kidney Diseases (contract numbers are listed above). Additional support was provided by the National Institute of Allergy and Infectious Diseases, the National Cancer Institute, the National Center for Minority Health and Health Disparities, and by General Clinical Research Center and Clinical and Translational Science Center grants from the National Center for Research Resources, National Institutes of Health (grant numbers are listed above). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health. Additional funding to conduct this study was supplied by Hoffmann-La Roche, Inc, through a Cooperative Research and Development Agreement with the National Institutes of Health.
This is publication #46 of the HALT-C Trial. The HALT-C Trial was registered with clinicaltrials.gov (#NCT00006164).