The INTEND 1 randomized controlled trial of duct endoscopy as an indicator of margin excision in breast conservation surgery.

PURPOSE: With early detection, breast conservation surgery with adequate surgical margins is the standard of care. The aim of this study was to evaluate the use of pre-operative duct endoscopy (DE) to target surgical resection, improve adequate margins and reduce re-excision operations. METHODS: Women with DCIS, stage I and II breast cancer suitable for breast conservation were randomized to DE-assisted wide local excision versus standard wide local excision (without DE). The primary endpoint was margin re-excision rates between the two groups. Secondary end points were: (i) volume differences of the surgical specimen; (ii) whether an extensive in situ component (EIC) influenced successful DE-guided resection. RESULTS: 78 women were randomized: 44 patients to no-DE and 34 patients to the DE group. The median age was 59 (49-65) and 56 (48-64) years in the two groups respectively with mean follow-up of 9.1 (4.2-11.1) years. There were 23 positive findings in 17 women in 30 successful DE procedures (17/30 = 56.7%). The surgical specimen volume, no-DE (17 [IQR 10-29] cm3) and DE 20 [IQR 12-28] cm3), did not differ, p = 0.377. The overall re-excision rate was 20/78 (26%), 9 (20%) and 11 (32% in the no-DE and DE groups, respectively, p = 0.233. CONCLUSIONS: This randomized clinical trial was limited by incomplete accrual. DE did not contribute to improved margin excision rates whether a target lesion was visualized or not. The presence of EIC did not improve efficacy of DE.

Volume of blood suctioned during vacuum-assisted breast biopsy predicts later hematoma formation.

BACKGROUND: To evaluate whether the volume of blood suctioned during vacuum-assisted breast biopsy (VABB) is associated with hematoma formation and progression, patient's age and histology of the lesion. FINDINGS: 177 women underwent VABB according to standardized protocol. The volume of blood suctioned and hematoma formation were noted at the end of the procedure, as did the subsequent development and progression of hematoma. First- and second-order logistic regression was performed, where appropriate. Cases with hematoma presented with greater volume of blood suctioned (63.8 +/- 44.7 cc vs. 17.2 +/- 32.9 cc; p < 0.001, Mann-Whitney-Wilcoxon test for independent samples, MWW); the likelihood of hematoma formation was increasing till a volume equal to 82.6 cc, at which the second-order approach predicts a maximum. The volume of blood suctioned was positively associated with the duration of the procedure (Spearman's rho = 0.417, p < 0.001); accordingly, hematoma formation was also positively associated with the latter (p = 0.004, MWW). The volume of blood suctioned was not associated with patients' age, menopausal status and histopathological diagnosis. CONCLUSION: The likelihood of hematoma is increasing along with increasing amount of blood suctioned, reaching a plateau approximately at 80 cc of blood lost.

Breast ductal endoscopy: how many procedures qualify?

BACKGROUND: Breast ductal endoscopy is a relatively new diagnostic method with ever growing importance in the work-up of patients with bloody nipple discharge. The ability to perform ductal endoscopy is very important and useful for breast fellows. Learning curve in breast ductal endoscopy remains a terra incognita, since no systematic studies have addressed this topic. The purpose of this study is to determine the point (number of procedures during training) beyond which ductal endoscopy is successfully performed. FINDINGS: Ten breast fellows received training in our Breast Unit. For the training process, an ex vivo model was adopted. Fellows were trained on 20 surgical specimens derived from modified radical mastectomy for breast cancer. The target of the education program was to acquire proficiency in performing ductoscopy. The achievement of four consecutively successful ductal endoscopies was determined as the point beyond which proficiency had been achieved. The number of procedures needed for the achievement of proficiency as defined above ranged between 9 and 17 procedures. The median value was 13 procedures; i.e. 50% of trainees had achieved proficiency at the 13th procedure or earlier. CONCLUSION: These pilot findings point to approximately 13 procedures as a point beyond which ductal endoscopy is successfully performed; studies on a larger number of fellows are nevertheless needed. Further research, focusing on the learning curves of different training models of ductal endoscopy, seems desirable.

Evaluation of pain experienced during breast ductal endoscopy.

PURPOSE: Ductal endoscopy is valuable for the differential diagnosis of bloody nipple discharge; however, the pain associated with this procedure has not been evaluated. This study aims to assess the pain experienced by patients during ductal endoscopy. METHODS: We studied a consecutive series of women who underwent ductal endoscopy, to investigate the cause of bloody nipple discharge. The procedure was performed using standard local anesthesia (lidocaine 1% 10 ml without epinephrine, involving nipple block and periaureolar administration). Patients were asked to score the level of pain with a visual analog scale, 1, 4, 7, 12, 17, 22, 27, and 32 min after the procedure, and describe their overall and maximum pain. RESULTS: This series comprised 20 women aged from 27 to 68 years old. The overall pain (mean +/- SE) score was equal to 5.8 +/-0.3, and the maximum pain score was 8.3 +/- 0.2. The peak of pain corresponded with when the dilator was inserted through the sphincter. The group in which the dilator was inserted after 4 min experienced more intense maximum and overall pain after 7, 12, 17 and 22 min. CONCLUSIONS: Pain is an important factor in ductal endoscopy, and peaks relatively early. A standard, baseline local lidocaine dose of greater than 10 ml may be necessary at the beginning of the procedure. Late insertion of the dilator seems to be an indicator of the force of the procedure.

Pain during vacuum-assisted breast biopsy: are there any predictors?

INTRODUCTION: To assess the putative predictors that may be implicated in the pain experienced during stereotactic vacuum-assisted breast biopsy (VABB). MATERIALS AND METHODS: One hundred and thirty-five consecutive women with microcalcifications underwent VABB on the Fischer's table. The visual analogue scale was used to measure the degree of the "average pain" (AP). RESULTS: At the univariable analysis, the AP was positively associated with the duration of the procedure, the diagnosis of malignant/preinvasive lesions and the volume of blood lost. Although menopausal status was not associated with the AP, within the premenopausal subpopulation, luteal phase was associated with higher VAS score. These findings also persisted at the multivariable ordinal logistic regression model. However, the mean experienced pain was associated neither with the volume of tissue excised nor with the hematoma formation, nor with patients' age. CONCLUSION: The aforementioned factors were independent positive predictors of the mean experienced pain during VABB.

Minimizing underestimation rate of microcalcifications excised via vacuum-assisted breast biopsy: a blind study.

PURPOSE: The main disadvantage of Vacuum Assisted Breast Biopsy (VABB) is the probability of underestimating atypical ductal hyperplasia (ADH) and ductal carcinoma in situ (DCIS). This study evaluates a modified way of performing VABB. METHODS: 266 women with microcalcifications graded BI-RADS 3&4 underwent VABB (11G) on the Fischer's table. 133 women were allocated to the "standard" protocol and 24 cores were obtained (1 offset-main target and one additional offset). 133 women were randomly allocated to the "extended" protocol and 96 cores were excised (one offset- main target and 7 peripheral offsets). A preoperative diagnosis was established, and the removed volume was calculated. When precursor or malignant lesions were diagnosed, open surgery was performed. A second pathologist, blind to the preoperative results and to the protocol made the postoperative diagnosis. The discrepancy between preoperative and postoperative diagnoses was evaluated. RESULTS: When the standard protocol was applied, the underestimation rate for preoperative ADH, lobular neoplasia (LN), DCIS was 16.7%, 50% and 14.3% correspondingly. In the extended protocol, no underestimation was present in LN, ADH, but the underestimation rate for DCIS was 6.3%. In the extended protocol, no precursor/malignant tissue was left after VABB in all ADH cases, in 87.5% of LN cases, in 73.3% of DCIS, and in 50% of invasive carcinomas. The volume excised was 2.33 +/- 0.60 cc and 6.14 +/- 1.30 cc for the standard and the extended protocol, respectively. The rate of hematoma formation did not differ between the two protocols. CONCLUSIONS: This recently introduced, "extended" way of performing VABB in microcalcifications safely minimizes the underestimation rate, which may lead to a modified management of ADH lesions.

Vacuum-assisted breast biopsy: the value and limitations of cores with microcalcifications.

The aim of this study was to assess cores with microcalcifications (CM) and without microcalcifications (CWM) obtained from vacuum-assisted breast biopsy (VABB). The study included 12 atypical ductal hyperplasias (ADH), 37 ductal carcinomas in situ (DCIS), and seven invasive ductal carcinomas (IDC) diagnosed by VABB (11G) on the Fischer's table. More than 24 cores were excised. For CM/CWM, a separate pathology report was given. Open surgery followed, and underestimation was calculated. The CM/CWM discrepancy was evaluated (superiority, identity, and inferiority). CWM failed to make the diagnosis in 8.3% and 35.1% of ADH and DCIS, respectively. In 28.6% of IDC, diagnosis was made through CWM. CM volume was 1.2+/-0.3 cm(3) for the two IDCs missed by CM, 1.0+/-0.4 cm(3) for the 40 cases of identical diagnoses, and 1.4+/-0.5 cm(3) for the 14 cases of CM superiority (p=0.048, Kruskal-Wallis test). CWM volume was 6.3+/-1.8 cm(3) for the two IDCs missed by CM, 2.6+/-1.8 cm(3) for cases with identical diagnoses, and 3.4+/-1.6 cm(3) for cases of CM superiority (p=0.018, Kruskal-Wallis test). The underestimation rate was 8.3% in ADH, and 10.8% in DCIS. CMs are superior in DCIS/ADH diagnosis. However, CWM may be valuable for the diagnosis of the invasive component.