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HelpTest Code FBILM Biliary Tract Malignancy-Cytology, FISH, Varies
Specimen Required
Supplies:
PreservCyt Vial (T536)
CytoLyt Solution (T564)
Specimen Type: Bile duct brushing, bile duct aspirate, hepatobiliary brushing, or hepatobiliary aspirate
Container/Tube: Separate ThinPrep vial containing 20 mL PreservCyt or CytoLyt solution for each specimen
Specimen Volume: Entire collection
Collection Instructions: Label with site specimen was collected from (eg, right hepatic duct or common bile duct).
Secondary ID
70587Useful For
Assessing bile duct brushing or hepatobiliary brushing specimens for bile tract malignancy
Additional Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| BILMA | Biliary Tract Malignancy, FISH | No | Yes |
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| BILMB | Biliary Tract Malignancy, FISH | No | No |
| BILMC | Biliary Tract Malignancy, FISH | No | No |
| BILMD | Biliary Tract Malignancy, FISH | No | No |
| BILME | Biliary Tract Malignancy, FISH | No | No |
| BILMF | Biliary Tract Malignancy, FISH | No | No |
Testing Algorithm
When this test is ordered, fluorescence in situ hybridization testing will be performed. When additional specimens are received, the laboratory will add BILMA to the first specimen, BILMB to the second specimen, BILMC to the third specimen, and so on.
Method Name
Cytology Light Microscopy and Fluorescence In Situ Hybridization (FISH)
Reporting Name
Biliary Tract Malignancy-Cyto/FISHSpecimen Type
VariesSpecimen Minimum Volume
See Specimen Required
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Refrigerated (preferred) | ||
| Ambient | |||
Reject Due To
| Pancreatic mass Pancreatic cyst Pancreatic fine-needle aspiration (FNA) |
Reject |
Clinical Information
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.
Fluorescence in situ hybridization (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 specimens is superior to that of conventional cytology.
Reference Values
Negative for malignancy.
Interpretation
An interpretive report will be provided.
A positive cytology diagnosis is normally definitive for the presence of malignancy.
Suspicious or atypical results need further confirmation by clinical observation, repeat cytology, or perhaps appropriate biopsy.
Cautions
A positive FISH result does not identify location or type of malignancy. FISH abnormalities may be associated with high-grade dysplasia or carcinoma in situ. Cytology and biopsy may help clarify such situations.
Supportive Data
Cell counts using the biliary FISH probe set on pancreatobiliary brushings were compared between 49 patients with malignancy and 41 patients without malignancy to determine normal value cutoffs for this assay. The cutoff values were independently validated in a blinded study from brushing samples collected from 112 patients at the time of endoscopic retrograde cholangiopancreatography (ERCP). Among patients with malignancy on follow-up, the sensitivity of a polysomy FISH result was significantly superior to cytology (74% vs. 28%, P<0.001). The specificity of FISH and cytology were similar (96% vs. 100%).
Clinical Reference
1. Barr Fritcher EG, Voss JS, Brankley SM, et al. An optimized set of fluorescence in situ hybridization probes for detection of pancreatobiliary tract cancer in cytology brush samples. Gastroenterology. 2015;149(7):1813-1824
2. Barr Fritcher EG, Kipp BR, Voss JS, et al. The development of a tailored pancreatobiliary fluorescence in situ hybridization (FISH) assay to improve detection of malignancy in pancreatobiliary brushings. J Mol Diagn. 2013;15(6):909
3. Barr Fritcher EG, Kipp BR, Halling KC, et al. A multivariable model using advanced cytologic methods for the evaluation of indeterminate pancreatobiliary strictures. Gastroenterology. 2009;136(7):2180-2186
Method Description
Standard brush cytology sampling is performed on patients undergoing endoscopic retrograde cholangiopancreatography 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 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 1q21 (MCL1), 7p12 (EGFR), 8q24 (MYC), and 9p21 (CDKN2A) (Abbott Molecular Inc) 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 assess 100 consecutive epithelial cells for gains and losses of probe signals (ie, chromosomal loci). Specimens are considered abnormal if cell counts exceed predetermined cutoff values for one or more of the following abnormalities: polysomy, homozygous 9p21 loss, single locus gain, single locus gain with 9p21 loss in the same cells, and/or tetrasomy. If the cutoff for polysomy is not attained in the 100-cell enumeration, then the remainder of the slide is assessed for polysomy until the cutoff is reached or the slide is exhausted.(Unpublished Mayo method)
Day(s) Performed
Monday through Friday
Report Available
7 to 10 daysSpecimen Retention Time
Up to 1 week depending on the resultsPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test was developed using an analyte specific reagent. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
88112
88377 (if appropriate)
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| FBILM | Biliary Tract Malignancy-Cyto/FISH | 95230-9 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 71291 | Interpretation | 69965-2 |
| 71292 | Participated in the Interpretation | No LOINC Needed |
| 71293 | Report electronically signed by | 19139-5 |
| 71294 | Addendum | 35265-8 |
| 71295 | Gross Description | 22634-0 |
| CY070 | Collection Procedure | 33724-6 |
| CY042 | Source | 22633-2 |
| CY043 | Clinical History | 22636-5 |
| CY044 | Fixative | 8100-0 |
| 71570 | Disclaimer | 62364-5 |
| 71816 | Case Number | 80398-1 |