When is liver biopsy needed in the diagnosis of primary biliary cirrhosis?

Zein, Claudia O.; Angulo, Paul; Lindor, Keith D.

doi:10.1053/cgh.2003.50014

Cited by 90 publications

(55 citation statements)

References 17 publications

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“…After 6 years of follow-up, the patients with overlap had significantly worse clinical outcomes than the nonoverlap PBC patients, thus confirming the potential importance of using liver biopsy to establish the correct diagnosis. 23 It was recognized that in one study, the presence of AMA and cholestatic enzymes in a middle aged woman had a 98% positive predictive value for the presence of PBC, 3 obviating the need for a liver biopsy for diagnostic purposes. However, this study was conducted and validated in centers of excellence for PBC by experienced investigators.…”

Section: Entry Criteriamentioning

confidence: 99%

“…It is less useful in assessing improvement in patients with mild to moderate disease, a group which may actually be the most responsive to therapy. Response of ALP to therapy has been shown to be a good correlate of both survival 17 and liver histology 3 in PBC and is used globally in clinical practice to predict the progression of the disease; it is therefore an acceptable therapeutic criterion to monitor PBC treatment. Analysis of UDCA trials demonstrated that normalization of ALP, when assessing a large group, was associated with better survival than expected.…”

Section: Biochemical Markersmentioning

confidence: 99%

“…In this context, the best diagnostic tool for PBC is the measurement of anti-mitochondrial antibodies (AMA), which are characteristic of PBC and are present in at least 95% of the cases. 2 Liver biopsy is not required for clinical diagnosis in PBC, 3 but may be helpful in selected situations such as stratification of patients within clinical trials and in some cases may be used as study endpoints. Earlier epidemiological studies report an annual incidence ranging from 2.27 to 32 per million 4,5 with a female-to-male sex ratio averaging approximately 10:1, 6 although over the last decade the disease is reported more frequently, perhaps at least in part due to greater disease awareness.…”

Section: Introductionmentioning

confidence: 99%

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American Association for the Study of Liver Diseases Endpoints Conference: Design and Endpoints for Clinical Trials in Primary Biliary Cirrhosis

et al. 2010

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PreambleA group of multidisciplinary experts on primary biliary cirrhosis (PBC) and its complications convened on May 31, 2009, under the aegis of the American Association for the Study of Liver Diseases (AASLD) in order to identify the most appropriate design and endpoints for clinical trials of PBC based on current evidence and expert experience. The natural history of PBC was reviewed as well as current therapies. The current approaches to evaluating therapies for disease progression and symptoms as priorities were discussed. Appropriate aspects of trial design including entry criteria, study duration, and appropriate handling of issues such as stratification of subjects and use of ursodeoxycholic acid (UDCA), were identified and discussed. After a full day of presentations, in a consensus manner, appropriate endpoints for clinical efficacy trials regarding PBC and its complications were agreed upon and are reported in this summary.

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Section: Entry Criteriamentioning

confidence: 99%

Section: Biochemical Markersmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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American Association for the Study of Liver Diseases Endpoints Conference: Design and Endpoints for Clinical Trials in Primary Biliary Cirrhosis

et al. 2010

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“…In fact, some have proposed that, although a diagnosis of AMA-positive PBC can be made without a liver biopsy, a diagnosis of AMA-negative PBC cannot be made without one. 25 It is estimated that approximately 5% to 8% of cases of PBC are negative for AMA. 13,18,21 These patients follow a clinical course similar to that of AMA-positive patients.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Langerhans Cell Infiltrate by CD1a Immunostain in Liver Biopsy for the Diagnosis of Primary Biliary Cirrhosis

Graham

Smyrk

Zhang

2012

American Journal of Surgical Pathology

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Primary biliary cirrhosis (PBC) is characterized by chronic nonsuppurative destructive cholangitis, which is considered to be a cell-mediated immune reaction. Antigen-presenting cells, including Langerhans cells and dendritic cells, have been found in portal tracts and in bile duct epithelium and may play a role in the pathogenesis of PBC, but the importance of identifying these cells for diagnosing PBC has not been studied yet. In this study, we sought to evaluate the importance of identifying Langerhans cells using a CD1a immunostain in the diagnosis of PBC. Liver biopsies from adult patients diagnosed with PBC (n=60), primary sclerosing cholangitis (n=29), obstructive cholangitis (n=13), chronic viral hepatitis B or C (n=19), autoimmune hepatitis (AIH, n=15), acute cellular rejection (n=11), and chronic rejection (n=10) at our institution were retrospectively reviewed. An immunohistochemical stain for CD1a was used to detect Langerhans cells, and the distribution of CD1a-positive Langerhans cell infiltrate was recorded as lobular, portal with bile duct sparing, and intraepithelial. Intraepithelial Langerhans cells were identified in 58% of PBC including antimitochondrial antibody-negative PBC and PBC-AIH overlap cases, 14% of primary sclerosing cholangitis, 15% of obstructive cholangitis, 9% of acute cellular rejection, 6% of AIH, and no cases of chronic viral hepatitis or chronic rejection. The number of intraepithelial Langerhans cells was significantly higher in PBC than in other conditions, with the mean number of CD1a-positive intraepithelial Langerhans cells per bile duct in PBC calculated as 2.2 compared with <1 per duct for the other control cases. Thirty-three of 60 (55%) PBC cases showed at least one bile duct containing ≥2 CD1a-positive Langerhans cells. This was statistically significant (P<0.01) when compared with control groups. The overall sensitivity and specificity of using ≥2 CD1a-positive Langerhans cells per bile duct as the diagnostic criteria for PBC were 55% and 96%. Given the heterogenous nature of liver involvement by PBC, a review of cases with morphologic features of duct damage yielded an increased sensitivity (79%) with no reduction in specificity. In conclusion, the detection of a Langerhans cell infiltrate of ≥2 cells by CD1a in a given bile duct on needle biopsy may be a valuable tool in the diagnosis of PBC.

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“…• The need for liver biopsy in all patients with primary biliary cirrhosis and primary sclerosing cholangitis. In most cases the diagnosis can be established without liver biopsy on the basis of a cholestatic pattern of liver chemistries and either antimitochondrial antibodies in primary biliary cirrhosis [23] or cholangiography in primary sclerosing cholangitis [24]; scoring systems based on readily ascertained clinical variables can be used to assess prognosis and response to therapy [22,23]. • The need for protocol liver biopsies in all liver transplant recipients.…”

Section: Indicationsmentioning

confidence: 99%

Controversies in liver biopsy: Who, where, when, how, why?

Friedman

2004

Curr Gastroenterol Rep

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Liver biopsy continues to have a central role in the evaluation of patients with suspected liver disease. The procedure is often indicated to evaluate otherwise unexplained liver biochemical test abnormalities, but the precise degree of serum aminotransferase elevations that should prompt a liver biopsy is controversial, as is the need for liver biopsy in all patients with suspected nonalcoholic fatty liver disease and chronic hepatitis C. Standard liver biopsy is contraindicated in patients with severe coagulopathy and ascites, although the degree of coagulopathy that contraindicates a liver biopsy is controversial. A transjugular approach is an alternative in patients with coagulopathy or ascites. Controversy surrounds all the technical aspects of liver biopsy, particularly the choice of needle (cutting vs suction) and the use of ultrasound to mark or guide the biopsy site. Bleeding is the major complication of liver biopsy, with a risk of 0.3%; cutting needles are more likely to cause hemorrhage than are suction needles. Traditionally, liver biopsy has been the province of the hepatologist/ gastroenterologist. However, an increasing number of liver biopsies are performed by radiologists. The implications of this trend with respect to patient outcome, safety, and training of fellows is unclear.

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When is liver biopsy needed in the diagnosis of primary biliary cirrhosis?

Cited by 90 publications

References 17 publications

American Association for the Study of Liver Diseases Endpoints Conference: Design and Endpoints for Clinical Trials in Primary Biliary Cirrhosis

American Association for the Study of Liver Diseases Endpoints Conference: Design and Endpoints for Clinical Trials in Primary Biliary Cirrhosis

Evaluation of Langerhans Cell Infiltrate by CD1a Immunostain in Liver Biopsy for the Diagnosis of Primary Biliary Cirrhosis

Controversies in liver biopsy: Who, where, when, how, why?

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