Original article—liver, pancreas, and biliary tract
Complication Rate of Percutaneous Liver Biopsies Among Persons With Advanced Chronic Liver Disease in the HALT-C Trial

https://doi.org/10.1016/j.cgh.2010.03.025Get rights and content

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.

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:

References (31)

  • L. Sandrin et al.

    Transient elastography: a new noninvasive method for assessment of hepatic fibrosis

    Ultrasound Med Biol

    (2003)
  • J.L. Dienstag

    The role of liver biopsy in chronic hepatitis C

    Hepatology

    (2002)
  • D. van der Poorten et al.

    Twenty-year audit of percutaneous liver biopsy in a major Australian teaching hospital

    Intern Med J

    (2006)
  • R.P. Myers et al.

    Utilization rates, complications and costs of percutaneous liver biopsy: a population-based study including 4275 biopsies

    Liver Int

    (2008)
  • J.F. Huang et al.

    The incidence and risks of liver biopsy in non-cirrhotic patients: an evaluation of 3806 biopsies

    Gut

    (2007)
  • Cited by (357)

    • Noninvasive assessment of liver disease severity: image-related

      2023, Comprehensive Guide to Hepatitis Advances
    View all citing articles on Scopus

    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).

    View full text