For Pathologists

MarginMarker histology marking dye and CorrectClips radiographic markers can add clarity and reduce error.

Pathologists lead the standardization of specimen marking to ensure the highest quality of analysis for all cancer patients.


The Problem

In cancer surgery, the single most important predictor of local recurrence is the tissue margins.1 Customary methods used to label tissue margins cause error. Medical research shows discordance rates of 31% to 52% in the identification of specimen margins between surgery, pathology and radiology.2, 3 This error may lead to unnecessary re-excisions or cancer recurrence.4

The Solution

MarginMarker® sterile ink kit and CorrectClips® radiographic markers remove inconsistencies, reducing error and ambiguity. The pathology lab receives specimens with margins accurately and uniformly marked.

Standardization

Pathology receives specimens marked with a consistent color coding scheme which completely defines each of the six tissue margins. Entire surface areas are indicated, and irregularities and fissures on the surface are clearly marked in relation to each margin.

Confidence

Validity of Markings
  • MarginMarker sterile inks define the edges of specimen margins; this is more complete than suture, which marks only one point to represent the entire margin plane, and which requires the pathologist to estimate margin boundaries.
  • Specimen markings by MarginMarker have greater validity than suture methods. CorrectClips detach easily with minimal interruption to tissue surface compared to suture. False positives can be reduced, as MarginMarker inks minimize migration into crevasses or punctures created by suture.
  • Pathologists have greater confidence that if re-excision is required, it is valid and necessary to prevent cancer recurrence, and that the designated margin for re-excision is correct.
Performance of MarginMarker Inks
  • MarginMarker sterile inks adhere throughout specimen processing; the colors show brightly on slides, easily distinguishing each margin. There is no need to apply additional ink.
  • MarginMarker sterile inks can be used when specimen sterility is maintained for cytogenetic analysis or microbiology testing.
  • MarginMarker sterile inks are packaged for single use, minimizing the risk of cross-contamination from other specimens.

Results

Better Patient Outcomes
  • Fewer unnecessary re-excisions 1, 5
  • More accurate re-excisions 1, 5, 6
  • Potentially lower cancer recurrence 7, 8, 9
Efficiency
  • Promotes clear, systematic pathologist-surgeon communication
Compliance
  • MarginMarker and CorrectClips are in compliance with 2012 CAP Accreditation Guidelines for specimen handling by maintaining margin designation during fixation 10

References

 

1. Dooley, W.C. and Parker, J. “Understanding the Mechanisms Creating False Positive Lumpectomy Margins.” American Journal of Surgery 190 (2005): 606-608.

2. Britton, P.D.; Sonoda, L.I.; Yamamoto, A.K.; Koo, B.; Soh, E.; and Goud, A. “Breast Surgical Specimen Radiographs: How Reliable Are They?” European Journal of Radiology 79 (2011): 245-249.

3. Molina, M.A.; Snell, S.; Franceschi, D.; Jorda, M.; Gomez, C.; Moffat, F.L.; Powell, J.; and Avisar, E. “Breast Specimen Orientation.” Annals of Surgical Oncology 16 (2009): 285-288.

4. McCahill, L.E.; Single, R.M.; Aiello Bowles, E.J.; Feigelson, H.S.; James, T.A.; Barney, T.; Engel, J.M.; and Onitilo, A.A. “Variability in Reexcision Following Breast Conservation Surgery.” Journal of the American Medical Association 307.5 (2012): 467-475.

5. Singh, M.; Singh, G.; Hogan, K.T.; Atkins, K.A.; and Schroen, A.T. “The Effect of Intraoperative Specimen Inking on Lumpectomy Re-excision Rates.” World Journal of Surgical Oncology 8.4 (2010).

6. Lovrics, P.J.; Cornacchi, S. D.; Farrokhyar, F.; Garnett, A.; Chen, V.; Franic, S.; and Simunovic, M. “The Relationship Between Surgical Factors and Margin Status After Breast-Conservation Surgery for Early Stage Breast Cancer.” The American Journal of Surgery (2009): 197, 740-746.

7. Gibson, G.R.; Lesnikoski, B.A.; Yoo, J.; Mott, L.A.; Cady, B.; and Barth, R.J. Jr. “A Comparison of Ink-Directed and Traditional Whole-Cavity Re-Excision for Breast Lumpectomy Specimens with Positive Margins.” Annals of Surgical Oncology 8.9 (2001): 693-704.

8. Menes, T.S.; Tartter, P.I.; Bleiweiss, I.; Godbold, J.H.; Estabrook, A.; and Smith, S.R. “The Consequence of Multiple Re-excisions to Obtain Clear Lumpectomy Margins in Breast Cancer Patients.” Annals of Surgical Oncology 12.11 (2005): 881-885.

9. Gage, I.; Schnitt, S.J.; Nixon, A.J.; Silver, B.; Recht, A.; Troyan, S.L.; Eberlein, T.; Love, S.M.; Gelman, R.; Harris, J.R.; and Connolly, J.L. “Pathologic Margin Involvement and the Risk of Recurrence in Patients Treated with Breast-Conserving Therapy.” Cancer 78.9 (1996): 1921-1928.

10. “Anatomic Pathology Checklist – Predictive Markers.” College of American Pathologists’ CAP Accreditation Program. ANP. 22998. July 11, 2011.

Additional Medical References