title: Surgical complications associated with sentinel lymph node biopsy: results from a prospective international cooperative group trial.
abstract: 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.
authors.affiliation: Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA.
authors.forename: Lee Gravatt
authors.initials: LG
authors.lastname: Wilke
authors.forename: Linda M
authors.initials: LM
authors.lastname: McCall
authors.forename: Katherine E
authors.initials: KE
authors.lastname: Posther
authors.forename: Pat W
authors.initials: PW
authors.lastname: Whitworth
authors.forename: Douglas S
authors.initials: DS
authors.lastname: Reintgen
authors.forename: A Marilyn
authors.initials: AM
authors.lastname: Leitch
authors.forename: Sheryl G A
authors.initials: SG
authors.lastname: Gabram
authors.forename: Anthony
authors.initials: A
authors.lastname: Lucci
authors.forename: Charles E
authors.initials: CE
authors.lastname: Cox
authors.forename: Kelly K
authors.initials: KK
authors.lastname: Hunt
authors.forename: James E
authors.initials: JE
authors.lastname: Herndon
authors.forename: Armando E
authors.initials: AE
authors.lastname: Giuliano
mesh_terms: D000367:Age Factors; D000707:Anaphylaxis / Q000209:etiology; D001365:Axilla / Q000473:pathology*; D015992:Body Mass Index; D001943:Breast Neoplasms / Q000473:pathology* / Q000601:surgery; D005260:Female; D006406:Hematoma / Q000209:etiology; D006801:Humans; D007391:International Cooperation; D010292:Paresthesia / Q000209:etiology; D011446:Prospective Studies; D012394:Rosaniline Dyes / Q000009:adverse effects; D021701:Sentinel Lymph Node Biopsy / Q000009:adverse effects; D049291:Seroma / Q000209:etiology; D013530:Surgical Wound Infection / Q000209:etiology
chemical_list: D012394:Rosaniline Dyes; C025484:iso-sulfan blue