Test ID: 84357
Biliary Tract Malignancy, Cytology & Molecular Testing
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Assessing bile duct brushing or hepatobiliary brushing specimens for malignancy
Additional Tests Lists test(s) that are always performed, at an additional charge, with the initial test(s)
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| 19229 | Biliary Tract Malignancy, FISH | No | Yes |
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
When this test is ordered, biliary tract malignancy testing by FISH will always be performed at an additional charge.
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Method Name A short description of the method used to perform the test
Fluorescence In Situ Hybridization (FISH)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
Bile duct cytology
Bile duct stricture malignancy, FISH
Cholangiocarcinoma, FISH
BILEM
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Specimen Type: Bile duct brushing and/or hepatobiliary brushing
Container/Tube: Separate ThinPrep vial containing 20 mL PreservCyt or CytoLyt solution (Supply T536) for each specimen
Specimen Volume: Entire collection
Collection Instructions: Label with site specimen was collected from (eg, right hepatic duct or common bile duct).
Forms: If not ordering electronically, submit a Pathology/Cytology Request Form (Supply T246) with the specimen.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | NA |
| Lipemia | NA |
| Icterus | NA |
| Other | Pancreatic mass, cyst, or fine-needle aspiration |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Varies | Ambient (preferred) | |
| Refrigerated | ||
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Endoscopic retrograde cholangiopancreatography (ERCP) is used to examine patients with biliary tract obstruction or stricture for possible malignancy. Biopsies and cytologic specimens are obtained at the time of ERCP. Cytologic analysis complements biopsy by sometimes detecting malignancy in patients with a negative biopsy. Nonetheless, a number of studies suggest that the overall sensitivity of bile duct brushing and bile aspirate cytology is quite low.
FISH is a technique that utilizes fluorescently labeled DNA probes to examine cells for chromosomal alterations. FISH can be used to detect cells with chromosomal changes (eg, aneuploidy) that are indicative of malignancy. Studies in our laboratory indicate that the sensitivity of FISH to detect malignant cells in biliary brush and bile aspirate specimens is superior to that of conventional cytology.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
An interpretive report will be provided.
Interpretation Provides information to assist in interpretation of the test results
The chance that the patient has cancer is calculated based on the following parameters: patient age, cytology results (negative, atypical, suspicious, positive, not available), FISH results (negative, trisomy, polysomy, not available), and primary sclerosing cholangitis (PSC) status (non-PSC vs. PSC patient). This information is then provided in the interpretive portion of the final report.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
A positive FISH result does not identify location or type of malignancy. Cytology and biopsy may help clarify such situations.
Supportive Data
Bile duct brushing and bile aspirate specimens were collected from 303 patients at the time of endoscopic retrograde cholangiopancreatography (ERCP). Cytological specimens from these patients were evaluated for malignancy with FISH and exfoliative cytology. Among patients with malignancy on follow-up, the sensitivity of FISH was superior to cytology (44% versus 15%, P<0.001). The specificity of FISH and cytology were similar (98% versus 100%, P=0.250).
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Kipp BR, Stadheim LM, Halling SA, et al: A comparison of routine cytology and fluorescence in situ hybridization for the detection of malignant bile duct strictures. Am J Gastroenterol 2004 September;99(9):1675-1681
2. Moreno Luna LE, Kipp BR, Halling KC, et al: Advanced cytologic techniques for the detection of malignant pancreatobiliary strictures. Gastroenterology 2006 October;131(4):1064-1072
3. Barr Fritcher EG, Kipp BR, Slezak JM, et al: Correlating routine cytology, quantitative nuclear morphometry by digital image analysis, and genetic alterations by fluorescence in situ hybridization to assess the sensitivity of cytology for detecting pancreatobiliary tract malignancy. Am J Clin Pathol 2007 August;128(2):272-279
Method Description Describes how the test is performed and provides a method-specific reference
Standard brush cytology sampling is performed on patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) for suspicious biliary tract strictures. Brushes are placed in a ThinPrep vial containing PreservCyt or CytoLyt solution. The specimen is sent in a single vial with or without the brush. If brush is present, it is removed and cells are collected from it by scraping them into a single vial containing 20 mL of PreservCyt solution. Two aliquots are prepared and used for each portion of the test. The cytology specimen is processed using the ThinPrep 2000 processor. Specimens are stained using a Papanicolaou stain and analyzed microscopically by a cytotechnologist and pathologist.
Biliary cells are harvested, fixed, and placed on a slide. Fluorescently-labeled DNA probes to the centromeres of chromosomes 3, 7, and 17 and to the 9p21 locus (UroVysion, Abbott Molecular, Inc., Des Plaines, IL) are hybridized to the cells on the slide. The slide is then washed and stained with DAPI (a nuclear counterstain). Fluorescence microscopy with unique band filters is used to scan the slide for atypical cells (eg, cells with nuclear enlargement or irregularity). These cells are assessed for gains of chromosomes 3, 7, and 17. Cells with chromosomal gains (polysomy or trisomy) are recorded. If 5 or more cells show polysomy, then the case is considered positive for polysomy. If 10 or more cells show trisomy of 1 of the chromosomes (most often chromosome 7), the case is considered positive for trisomy. (Unpublished Mayo method)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; 8:00 a.m. – 5:00 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
88112-Biliary tract malignancy, cytology
88368 x 4-Biliary tract malignancy, FISH
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| 19247 | Accession Number | N/A |
| 19248 | Referring Pathologist/Physician | 46608-6 |
| 19249 | Ref Path/Phys Address | In Process |
| 19250 | Material: | In Process |
| 19251 | Final Diagnosis: | 34574-4 |
| 19252 | Comment: | 48767-8 |
| 19253 | Revision Description: | In Process |
| 19254 | Signing Pathologist: | 19139-5 |
| 19865 | Specimen Description: | 33511-7 |
| 19255 | Special Procedures: | N/A |
| 19256 | SP Signing Pathologist: | N/A |
| 19257 | *Previous Report Follows* | N/A |
| 19258 | Addendum: | 35265-8 |
| 19259 | Addendum Comment: | 22638-1 |
| 19260 | Addendum Pathologist: | 19139-5 |
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