Table 2: Definition of and evaluation of surgical margins is essential for oncological sound treatment of breast cancer.
Study name |
Study design |
Number of patients |
Clear margin |
Volume of breast removed |
Clear Margin Definition |
Esgueva, et al. |
Prospective RCT |
N = 214 IOUS = 148 WL = 66 |
IOUS 94.5% WL 84.78% |
IOUS = 43.24 cc WL = 55.68 cc P = 0.02 |
< 5 mm by US & (≤ 2 mm) or positive margins by pathology. |
Fisher, et al. |
Non-Randomised trial |
IOUS = 73 PGE = 124 |
IOUS = 7 (10%) PGE = 20 (16%) |
IOUS = 2 cm3 PGE = 1.5 cm3 P = < 0.05 Tumour not lump |
Tumor cells at, or very close to (2 mm), the resection margin. |
Moore, et al. |
RCT |
IOUS = 27 PGE = 24 |
IOUS = 26 (96.5%) PGE = 17 (70%) |
IOUS = 104 +\- 8 cm3 PGE = 114 +/- 5.6 cm3 P = NS |
Any margin where tumor cells were microscopically visible on final histopathologic evaluation. |
Karanlik, et al. |
Prospective cohort |
IOUS = 84 PGE = 80 |
IOUS = 79 (94%) PGE = 66 (17%) |
IOUS = 89.9 (53.9) cm3 PGE = 108.1 (63.4) cm3 P = NS |
Margin was reported to be positive or less than 5 mm macroscopically |
Larson, et al. |
Retrospective cohort |
RG = 89 PGE = 92 |
IOUS = 26 (29.2%) PGE = 38 (41.3%) |
N/A |
< 2 mm for DCIS or tumor on ink for invasive cancer. |
Ramos, et al. |
Observational non-randomized |
IOUS = 225 |
IOUS = 24 (10.6%) 21 had re-excision in same surgery |
IOUS = 26.1 gm (5-110) |
Not clear or were close to the tumour (3 mm) |
Volders, et al. |
Prospective RCT |
IOUS = 65 PGE = 69 |
IOUS = 63 (97%) PGE = 57 (83%) P = 0.009 |
IOUS = 38 cc PGE = 53 cc P = 0.0004 |
Surgically-feasible healthy tissue margin of up to an arbitrarily chosen 1 cm |