Gastroenterology
Volume 136, Issue 7 , Pages 2180-2186, June 2009

A Multivariable Model Using Advanced Cytologic Methods for the Evaluation of Indeterminate Pancreatobiliary Strictures

  • Emily G. Barr Fritcher

      Affiliations

    • Department of Laboratory Medicine and Pathology, Mayo Clinic and Foundation, Rochester, Minnesota
  • ,
  • Benjamin R. Kipp

      Affiliations

    • Department of Laboratory Medicine and Pathology, Mayo Clinic and Foundation, Rochester, Minnesota
  • ,
  • Kevin C. Halling

      Affiliations

    • Department of Laboratory Medicine and Pathology, Mayo Clinic and Foundation, Rochester, Minnesota
  • ,
  • Trynda N. Oberg

      Affiliations

    • Department of Laboratory Medicine and Pathology, Mayo Clinic and Foundation, Rochester, Minnesota
  • ,
  • Sandra C. Bryant

      Affiliations

    • Division of Biostatistics, Mayo Clinic and Foundation, Rochester, Minnesota
  • ,
  • Robert F. Tarrell

      Affiliations

    • Division of Biostatistics, Mayo Clinic and Foundation, Rochester, Minnesota
  • ,
  • Gregory J. Gores

      Affiliations

    • Division of Gastroenterology and Hepatology, Mayo Clinic and Foundation, Rochester, Minnesota
  • ,
  • Michael J. Levy

      Affiliations

    • Division of Gastroenterology and Hepatology, Mayo Clinic and Foundation, Rochester, Minnesota
  • ,
  • Amy C. Clayton

      Affiliations

    • Department of Laboratory Medicine and Pathology, Mayo Clinic and Foundation, Rochester, Minnesota
  • ,
  • Thomas J. Sebo

      Affiliations

    • Department of Laboratory Medicine and Pathology, Mayo Clinic and Foundation, Rochester, Minnesota
  • ,
  • Lewis R. Roberts

      Affiliations

    • Division of Gastroenterology and Hepatology, Mayo Clinic and Foundation, Rochester, Minnesota
    • Corresponding Author InformationReprint requests Address requests for reprints to: Lewis R. Roberts, MBChB, PhD, Associate Professor of Medicine, Mayo Clinic College of Medicine, Miles and Shirley Fitterman Center for Digestive Diseases, 200 First Street SW, Rochester, Minnesota 55905. fax: (507) 284 0762

Received 2 October 2008; accepted 2 February 2009. published online 17 February 2009.

Background & Aims

Ancillary cytologic tests including digital image analysis (DIA) and fluorescence in situ hybridization (FISH) have been developed to improve the sensitivity of routine cytology (RC) for the diagnosis of malignancy in pancreatobiliary strictures. The goal of this study was to retrospectively compare the performance of RC, DIA, and FISH on clinical brushing specimens.

Methods

Endoscopic retrograde cholangiopancreatography brushings were obtained from 498 consecutive patients with pancreatobiliary strictures and analyzed by RC, DIA, and FISH as per standard practice. RC diagnostic categories included negative, atypical, suspicious, or positive. Aneuploid/tetraploid histograms were considered positive for DIA. FISH was performed using UroVysion (Abbott Molecular, Inc, Des Plaines, IL) and classified as negative, trisomy, tetrasomy, or polysomy.

Results

The sensitivity of polysomy FISH (42.9%) was significantly higher than RC (20.1%) when equivocal RC results were considered negative (P < .001) with identical specificity (99.6%). There was a significant difference in time for diagnosis of carcinoma between FISH diagnostic categories (P < .001) and between RC diagnostic categories (P < .001). Logistic regression analysis revealed that polysomy FISH, trisomy FISH, suspicious cytology, primary sclerosing cholangitis status, and age were associated with carcinoma (P < .05).

Conclusions

Polysomy FISH had high sensitivity without compromise to specificity. DIA was not a significant independent predictor of malignancy. Multivariable modeling using RC, FISH, age, and primary sclerosing cholangitis status can be used to estimate the probability of carcinoma for an individual patient. We recommend including FISH as a routine test where available, along with RC, in the evaluation of indeterminate pancreatobiliary strictures.

Abbreviations used in this paper: DIA, digital image analysis, ERCP, endoscopic retrograde cholangiopancreatography, FISH, fluorescence in situ hybridization, PSC, primary sclerosing cholangitis, RC, routine cytology

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 Conflicts of interest The authors disclose the following: Dr Kevin C. Halling has a patent on and receives royalties from the sale of the FISH probe set (UroVysion) discussed in this paper. The remaining authors disclose no conflicts.

PII: S0016-5085(09)00284-4

doi:10.1053/j.gastro.2009.02.040

Gastroenterology
Volume 136, Issue 7 , Pages 2180-2186, June 2009