Surgical complications associated with sentinel lymph node biopsy: Results from a prospective international cooperative group trial

Lee Gravatt Wilke, Linda M. McCall, Katherine E. Posther, Pat W. Whitworth, Douglas S. Reintgen, A. Marilyn Leitch, Sheryl G A Gabram, Anthony Lucci, Charles E. Cox, Kelly K. Hunt, James E. Herndon, Armando E. Giuliano

Research output: Contribution to journalArticlepeer-review

448 Scopus citations


Background: American College of Surgeons Oncology Group Z0010 is a prospective multicenter trial designed to evaluate the prognostic significance of micrometastases in the sentinel lymph nodes and bone marrow aspirates of women with early-stage breast cancer. Surgical complications associated with the sentinel lymph node biopsy surgical procedure are reported. Methods: Eligible patients included women with clinical T1/2N0M0 breast cancer. Surgical outcomes were available at 30 days and 6 months after surgery for 5327 patients. Patients who had a failed sentinel node mapping (n = 71, 1.4%) or a completion lymph node dissection (n = 814, 15%) were excluded. Univariate and multivariate analyses were performed to identify predictors for the measured surgical complications. Results: In patients who received isosulfan blue dye alone (n = 783) or a combination of blue dye and radiocolloid (n = 4192), anaphylaxis was reported in .1% of subjects (5 of 4975). Other complications included axillary wound infection in 1.0%, axillary seroma in 7.1%, and axillary hematoma in 1.4% of subjects. Only increasing age and an increasing number of sentinel lymph nodes removed were significantly associated with an increasing incidence of axillary seroma. At 6 months, 8.6% of patients reported axillary paresthesias, 3.8% had a decreased upper extremity range of motion, and 6.9% demonstrated proximal upper extremity lymphedema (change from baseline arm circumference of >2 cm). Significant predictors for surgical complications at 6 months were a decreasing age for axillary paresthesias and increasing body mass index and increasing age for upper extremity lymphedema. Conclusions: This study provides a prospective assessment of the sentinel lymph node biopsy procedure, as performed by a wide range of surgeons, demonstrating a low complication rate.

Original languageEnglish (US)
Pages (from-to)491-500
Number of pages10
JournalAnnals of Surgical Oncology
Issue number4
StatePublished - Apr 2006


  • Biopsy
  • Breast cancer
  • Complications
  • Sentinel lymph node

ASJC Scopus subject areas

  • Surgery
  • Oncology


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