Ductal Lavage Cytology

CPT: 88112
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Test Details

Synonyms

  • Breast Ductal Lavage Cytology
  • FirstCyte™ Breast Test

Use

Determine and/or differentiation of normal versus premalignant versus malignant cells

Limitations

Results of the test should not be used as absolute evidence for the presence or absence of breast carcinoma. The results of this test should only be as an adjunct to standard breast cancer detection methods including mammography and physical examination.

Methodology

FirstCyte™ Breast test

Specimen Requirements

Specimen

Aspirated breast duct material in CytoLyt® tube

Volume

Entire CytoLyt® tube

Minimum Volume

Entire CytoLyt® tube

Container

CytoLyt® solution (30 mL tube)

Patient Preparation

Refer to FirstCyte™ instructions for use.

Collection

Since collection kits are not supplied by LabCorp, the instructions supplied by the manufacturer should be followed. Procedures are outlined in the FirstCyte™ Breast Test package insert.

1. Determine the proper nipple and/or breast anesthetic that may be applied prior to initiating or during the ductal lavage procedure.

2. Dekeratinize the nipple using gauze and a small amount of mild abrasive skin prepping gel.

3. With the patient seated and her arms at her sides, wipe the nipple/areolar complex with alcohol or a suitable disinfectant and don gloves. Identify the ductal orifice by using the FirstCyte™ Aspirator (refer to the FirstCyte™ Aspirator instructions for use) and/or by firmly squeezing on the nipple from several directions to yield nipple aspirate fluid (NAF). Assist patient to a comfortable supine position.

4. Prepare the FirstCyte™ EZ MicroCatheter by attaching a 10 mL syringe containing 3 mL of 1% lidocaine without epinephrine to the green inflow port. Prime the inflow tubing with lidocaine, and close the pinch-clamp on the outflow tubing. The catheter tip may be dipped in sterile lidocaine jelly for lubrication.

5. While lifting up the nipple to two to three times its normal height, introduce the guidewire/catheter unit into NAF droplet of the desired ductal orifice. If cannulation is not readily accomplished by visual identification of NAF, employ a tactile approach to the duct. Hold the catheter perpendicular to the nipple surface and use gentle pressure (less than enough to dimple the nipple's surface) to probe for the ductal orifice.

6. Advance the guidewire/catheter unit until catheter is at nipple surface. Withdraw guidewire (not to exceed 10 mm) while slowly advancing catheter until fully seated. Remove guidewire completely.

• If entry into the orifice is difficult, a FirstCyte™ UltraSlim or Tapered Dilator may be used (refer to FirstCyte™ UltraSlim Dilator or FirstCyte™ Tapered Dilator instructions for use). After dilation of the duct, reinsert the catheter.

• If meeting resistance upon catheter insertion, as soon as the clear catheter body has entered the duct, withdraw the guidewire (approximately 6 mm), and slowly infuse 1-2 mL lidocaine (resistance is expected).

7. Slowly administer the lidocaine through the green inflow port into the breast duct. Advise the patient that the local anesthetic may sting or burn. Disconnect the empty 10 mL syringe and reattach to the outflow collection port.

8. Connect a 20 mL syringe filled with balanced electrolyte solution to the green inflow port. With the pinch clamp closed, gradually infuse 2-4 mL increments of balanced electrolyte solution, or less if the patient experiences discomfort. Open the pinch-clamp on the outflow tubing. Compress the breast towards the nipple with both hands, beginning at the base of the breast and rolling upward toward the nipple. Complete each stroke by compressing the lactiferous sinuses. Cloudy fluid and/or fine air bubbles may collect in the catheter body, indicating fluid flow. Pull back approximately 0.2 mL on the collection syringe to clear the chamber. (Pulling back more than 0.2 mL will simply transfer fluid from the inflow tubing to the outflow tubing.) Rotate hands to ensure that all quadrants of the breast are compressed. Deep compression followed by the collection of approximately 0.2 mL of ductal effluent should be repeated approximately three to four times.

9. Continue the cycles of infusing fluid into the duct, compressing the breast, and collecting ductal effluent until the duct has been lavaged with at least 20 mL of balanced electrolyte solution.

10. Pull back gently on the collection syringe plunger while removing the catheter from the patient to collect any residual effluent. Dispose of catheter appropriately.

11. Carefully mark the location of the cannulated duct on the 64 square nipple grid, drawing in any nipple landmarks that are evident. If patient indicated any areas of anesthetic inflow sensation, this may also be recorded on the nipple grid. Optional: Place a 11/2” piece of 2.0 Prolene knotted at the end into each duct. Mark the 12 o'clock (cephalad) position of the nipple with a pen and photograph the nipple. The Prolene markers provide a clear picture of ductal orifice location. Remove the knotted Prolene after photography.

12. Expel effluent into a CytoLyt® solution tube. If effluent volume exceeds the unfilled volume of the CytoLyt® solution tube, divide the effluent between an appropriate number of tubes. Secure the cap tightly until the two black indicator marks meet. Using a graphite pencil, immediately label the tube with sample identification (including patient's name) before continuing with the next duct.

13. Repeat Steps 4 through 12 for other identified orifices using a new FirstCyte™ EZ MicroCatheter and a fresh collection syringe and CytoLyt® Solution tube for each orifice.

14. Repeat Steps 2 through 13 for the contralateral breast. Discard all used devices appropriately.

15. Prepare the specimens for transport in accordance with all applicable regulations for transporting biological materials.

Repeat steps for other identified orifices using a new FirstCyte™ EZ MicroCatheter and a fresh collection syringe and CytoLyt® solution tube for each orifice.

Storage Instructions

Store in a cool dry place.

Causes for Rejection

Improper fixation; improper labeling; specimen submitted in vial that expired according to manufacturer's label

Clinical Information

Special Instructions

Include patient's name, birth date, sex, Social Security number, previous malignancy, drug therapy, radiation therapy, mammogram, and all other pertinent clinical information on the request form.

References

Dooley WC, Ljung BM, Veronesi U, et al. Ductal lavage for detection of cellular atypia in women at high risk for breast cancer. J Natl Cancer Inst. 2001 Nov 7; 93(21):1624-1632. 11698566
Fabian CJ, Kimler BF, Zalles CM, et al. Short-term breast cancer prediction by random periareolar fine-needle aspiration cytology and the Gail risk model. J Natl Cancer Inst. 2000 Aug 2; 92(15):1217-1227. 10922407
Wrensch MR, Petrakis NL, King EB, et al. Breast cancer incidence in women with abnormal cytology in nipple aspirates of breast fluid. Am J Epidemiol. 1992 Jan 15; 135(2):130-141. 1536131

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
009876 Ductal Lavage Cytology 191115 Specimen type: 22633-2
009876 Ductal Lavage Cytology 191152 Source: 22633-2
009876 Ductal Lavage Cytology 191160 Clinician provided ICD9: 52797-8
009876 Ductal Lavage Cytology 191174 Clinician provided ICD10: 52797-8
009876 Ductal Lavage Cytology 191158 ****************************** N/A
009876 Ductal Lavage Cytology 191118 DIAGNOSIS: 22637-3
009876 Ductal Lavage Cytology 191165 Recommendation: 22638-1
009876 Ductal Lavage Cytology 191140 Comment: 22638-1
009876 Ductal Lavage Cytology 191159 ****************************** N/A
009876 Ductal Lavage Cytology 191157 Pathologist provided ICD9: 52797-8
009876 Ductal Lavage Cytology 191175 Pathologist provided ICD10: 52797-8
009876 Ductal Lavage Cytology 191117 Clinical history: 22636-5
009876 Ductal Lavage Cytology 191126 Amended report: N/A
009876 Ductal Lavage Cytology 191127 Addendum: 22639-9
009876 Ductal Lavage Cytology 191147 Diagnosis provided by: N/A
009876 Ductal Lavage Cytology 191119 Signed out by: 19139-5
009876 Ductal Lavage Cytology 191120 Performed by: N/A
009876 Ductal Lavage Cytology 191116 Gross description: 22634-0
009876 Ductal Lavage Cytology 191156 Microscopic description: 22635-7
009876 Ductal Lavage Cytology 191141 Special procedure: N/A
009876 Ductal Lavage Cytology 191179 Previous history: N/A
009876 Ductal Lavage Cytology 191144 QA comment: N/A
009876 Ductal Lavage Cytology 019018 . 11546-9
009876 Ductal Lavage Cytology 000000 CPT Code Automation N/A
009876 Ductal Lavage Cytology 191167 Photomicrograph N/A

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The LOINC® codes are copyright © 1994-2017, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf