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AASLD Position Paper : Liver Biopsy

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AASLD Position Paper : Liver Biopsy AASLD POSITION PAPER Liver Biopsy Don C. Rockey,1 Stephen H. Caldwell,2 Zachary D. Goodman,3 Rendon C. Nelson,4 and Alastair D. Smith5 This position paper has been approved by the AASLD and College of Cardiology and the American Heart Associa- represents the position of the association. tion Practice Guidelines3).4 Introduction Preamble Histological assessment of the liver, and thus, liver bi- These recommendations provide a data-supported ap- opsy, is a cornerstone in the evaluation and management proach. They are based on the following: (1) formal re- of patients with liver disease and has long been considered view and analysis of the recently published world to be an integral component of the clinician’s diagnostic literature on the topic; (2) American College of Physi- armamentarium. Although sensitive and relatively accu- cians Manual for Assessing Health Practices and De- rate blood tests used to detect and diagnose liver disease signing Practice Guidelines1; (3) guideline policies, have now become widely available, it is likely that liver including the AASLD Policy on the Development and biopsy will remain a valuable diagnostic tool. Although Use of Practice Guidelines and the American Gastro- histological evaluation of the liver has become important enterological Association Policy Statement on Guide- in assessing prognosis and in tailoring treatment, nonin- lines2; and (4) the experience of the authors in the vasive techniques (i.e., imaging, blood tests) may replace specified topic. use of liver histology in this setting, particularly with re- Intended for use by physicians, these recommenda- gard to assessment of the severity of liver fibrosis.5,6 Sev- tions suggest preferred approaches to the diagnostic, ther- eral techniques may be used to obtain liver tissue; a table apeutic, and preventive aspects of care. They are intended including/defining specific terms has been provided in an to be flexible, in contrast to standards of care, which are effort to standardize terminology (Table 2). All liver bi- inflexible policies to be followed in every case. Specific opsy techniques require specific training so as to ensure recommendations are based on relevant published infor- appropriate-sized specimen retrieval and the lowest rate of mation. To more fully characterize the quality of evidence complications. Although liver biopsy is often essential in supporting recommendations, the Practice Guidelines the management of patients with liver disease, physicians Committee of the AASLD requires a Class (reflecting and patients may find it to be a difficult undertaking benefit versus risk) and Level (assessing strength or cer- because of the associated risks. The purpose of this prac- tainty) of Evidence to be assigned and reported with each tice guideline is to summarize the current practice of liver recommendation (Table 1, adapted from the American biopsy and make recommendations about its perfor- mance. This guideline deals exclusively with liver biopsy as it relates to adult liver disease. Abbreviations: AASLD, American Association for the Study of Liver Diseases; AIH, autoimmune hepatitis; ALF, acute liver failure; ALT, alanine aminotrans- Indications for Liver Biopsy—Overview ferase; ANA, antinuclear antibody; CT, computed tomography; HBV, hepatitis B virus; HCC, hepatocellular carcinoma; HCV, hepatitis C virus; HVPG, hepatic Historically, liver biopsy was used almost exclusively as venous pressure gradient; IgG, immunoglobulin G; INR, international normalized a diagnostic tool.7,8 However, as the result not only of new ratio; NAFLD, nonalcoholic fatty liver disease; PBC, primary biliary cirrhosis; PSC, primary sclerosing cholangitis; PT, prothrombin time; US, ultrasound. natural history data and the introduction of many new From the 1Division of Digestive and Liver Diseases, University of Texas South- therapies for patients with liver disease, liver biopsy and western Medical Center, Dallas, TX; 2Gastroenterology Division, University of histological assessment of the liver has now taken on an Virginia, Charlottesville, VA; 3Armed Forces Institute of Pathology, Washington, DC; 4Department of Radiology and 5Gastroenterology Division, Department of important role in clinical management. Therefore, as of Medicine, Duke University Medical Center, Durham, NC. 2009, liver biopsy currently has three major roles: (1) for Received November 12, 2008; accepted November 13, 2008. diagnosis, (2) for assessment of prognosis (disease stag- Address reprint requests to: Don C. Rockey, M.D., Division of Digestive and Liver ing), and/or (3) to assist in making therapeutic manage- Diseases, University of Texas Southwestern Medical Center, 5323 Harry Hines Boule- vard, Dallas, TX 75390-8887. E-mail: [email protected]; fax: ment decisions. 214-648-0274. Diagnosis. For many diseases, clinical and/or blood- Copyright © 2009 by the American Association for the Study of Liver Diseases. based tests suffice to establish a diagnosis (typical exam- Published online in Wiley InterScience (www.interscience.wiley.com). DOI 10.1002/hep.22742 ples include hepatitis B [HBV] or hepatitis C virus Potential conflict of interest: Nothing to report. [HCV] infection). Nonetheless, liver biopsy is often a 1017 1018 ROCKEY ET AL. HEPATOLOGY, March 2009 Table 1. Grading System for Recommendations Classification Description Class I Conditions for which there is evidence and/or general agreement that a given diagnostic evaluation, procedure or treatment is beneficial, useful, and effective Class II Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a diagnostic evaluation, procedure, or treatment Class IIa Weight of evidence/opinion is in favor of usefulness/efficacy Class IIb Usefulness/efficacy is less well established by evidence/opinion Class III Conditions for which there is evidence and/or general agreement that a diagnostic evaluation/procedure/treatment is not useful/effective and in some cases may be harmful Level of Evidence Description Level A Data derived from multiple randomized clinical trials or meta-analyses Level B Data derived from a single randomized trial, or nonrandomized studies Level C Only consensus opinion of experts, case studies, or standard-of-care critical component in establishing the diagnosis of many HCV or hemochromatosis10,11 or an “overlap” syndrome (other) forms of liver disease. Although histological assess- of PBC with AIH.12 ment alone may be able to make a diagnosis on occasion It is likely that liver biopsy will always play a role in the (i.e., a florid duct lesion in primary biliary cirrhosis management of the patient with a diagnostic dilemma. [PBC]), liver histology is typically and most appropriately This includes the patient with abnormal liver tests of un- considered in conjunction with the full gamut of clinical known etiology (see below) or the patient in whom a and laboratory data. Acute and chronic hepatitis, choles- specific liver disease has been considered, but has not yet tatic disorders, fatty liver disease, vascular diseases, infil- been confirmed. Examples include patients with a variety trative or storage diseases, some infectious and of possible diseases, including, but not limited to heredi- granulomatous diseases, and other disorders may be asso- tary disorders such as Wilson disease, alpha-1-antitrypsin ciated with characteristic histological abnormalities that disease, glycogen storage diseases, tyrosinemia, Niemann- are helpful in diagnosis.9 Liver biopsy is particularly useful Pick disease, amyloidosis, and others.13-26 Liver histology in patients with atypical clinical features. For example, may also be helpful diagnostically in patients with appar- liver histology can help distinguish between autoimmune ent systemic diseases in which the liver appears to be in- hepatitis (AIH) and nonalcoholic fatty liver disease volved. Microscopic examination of the liver in patients (NAFLD) in an obese patient with elevated levels of ala- with suspected hereditary hemorrhagic telangiectasia is nine aminotransferase (ALT), raised immunoglobulin G rarely necessary, and should probably be performed via concentration (IgG), and/or a positive antinuclear anti- the transvenous route, concomitant with measurement of body (ANA) titer. Liver histology may also be very helpful the portosystemic pressure gradient.15 Liver histology in patients with coexisting disorders such as steatosis and may provide important diagnostic information in pa- tients with acute liver failure (ALF).27 For example, liver biopsy is helpful in making a specific diagnosis in specific Table 2. Liver Biopsy Terminology settings (e.g., herpes virus infection, Wilson disease, AIH, Term Definition and malignancy),27,28 which in turn may guide more spe- Liver biopsy Any type of liver biopsy cific therapy. Transthoracic The most appropriate biopsy site is guided Liver histology in patients with hepatomegaly or ap- palpation/percussion- transcutaneous determined on the basis of guided clinical examination. Traditionally used in parent diffuse disease may help establish a diagnosis, but practice. whether it is clinically useful or cost effective is unknown. Transthoracic, image- The most appropriate biopsy site is determined or Examples of diffuse diseases include amyloidosis,29,30 guided confirmed usually by ultrasound (US) imaging before the biopsy granulomatous hepatitis caused by any of a number of Transthoracic, real-time The most appropriate biopsy site is determined by processes, and a host of other
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