Patient-reported outcomes of ductoscopy procedures for pathologic nipple discharge.

BACKGROUND: Pathologic nipple discharge (PND) is a common complaint often associated with breast cancer. However, when ultrasound and mammography are negative, the chances of malignancy are lower than 5%. Currently, major duct excision and microdochectomy are often recommended to alleviate symptoms and definitely rule out malignancy, but can cause infections and breastfeeding problems. Ductoscopy is a minimally invasive endoscopy technique that allows visualization of the mammary ducts and may not only obviate surgery but also detect malignancy. The aim of this study was to determine quality of life (QOL) after ductoscopy in patients with PND. MATERIALS AND METHODS: All PND patients referred for ductoscopy between 2014 and 2015 to our hospital were included. Ductoscopy procedures were performed under local anaesthesia in the outpatient clinic. Patients were asked to fill out questionnaires (Breast-Q, EQ-5D-5L and SF-36) on the day of ductoscopy, and after 2 weeks, 3 and 6 months. Additionally, we performed reliability analysis to determine if these questionnaires were suitable for PND patients. RESULTS: Fifty consecutive patients underwent ductoscopy of whom 47 patients participated in this study. One domain of SF-36 (vitality) varied significantly over time. Breast-Q, SF-36 and EQ-5D-5L showed that QOL after ductoscopy for PND was unaffected by ductoscopy. Success of the ductoscopy procedure was a significant predictor for satisfaction with the result domain. CONCLUSION: Ductoscopy is a minimally invasive technique that does not seem to impact QoL of PND patients over time. Breast-Q, SF-36 and EQ-5D-5L seem to be suitable existing QOL tests for PND patients undergoing ductoscopy, whereas SF-36 would require modifications.

Systematic review and meta-analysis of the diagnostic accuracy of ductoscopy in patients with pathological nipple discharge.

BACKGROUND: Invasive surgery remains the standard for diagnosis of pathological nipple discharge (PND). Only a minority of patients with nipple discharge and an unsuspicious finding on conventional breast imaging have cancer. Ductoscopy is a minimally invasive alternative for evaluation of PND. This systematic review and meta-analysis was designed to evaluate the diagnostic accuracy of ductoscopy in patients with PND. METHODS: A systematic search of electronic databases for studies addressing ductoscopy in patients with PND was conducted. Two classification systems were assessed. For DSany , all visualized ductoscopic abnormalities were classified as positive, whereas for DSsusp , only suspicious findings were considered positive. After checking heterogeneity, pooled sensitivity and specificity of DSany and DSsusp were calculated. RESULTS: The search yielded 4642 original citations, of which 20 studies were included in the review. Malignancy rates varied from 0 to 27 per cent. Twelve studies, including 1994 patients, were eligible for meta-analysis. Pooled sensitivity and specificity of DSany were 94 (95 per cent c.i. 88 to 97) per cent and 47 (44 to 49) per cent respectively. Pooled sensitivity and specificity of DSsusp were 50 (36 to 64) and 83 (81 to 86) per cent respectively. Heterogeneity between studies was moderate to large for sensitivity (DSany : I2 = 17·5 per cent; DSsusp : I2 = 37·9 per cent) and very large for specificity (DSany : I2 = 96·8 per cent; DSsusp : I2 = 92·6 per cent). CONCLUSION: Ductoscopy detects about 94 per cent of all underlying malignancies in patients with PND, but does not permit reliable discrimination between malignant and benign findings.

Interventional ductoscopy in patients with pathological nipple discharge.

BACKGROUND: Surgery is the intervention of choice for definitive diagnosis and treatment in women with pathological nipple discharge (PND). Ductoscopy has been reported to improve diagnosis, but as an interventional procedure it may also reduce the need for surgery. This study evaluated interventional ductoscopy in patients with PND. METHODS: A prospective study on ductoscopy was conducted in consecutive patients with PND, but without a suspected malignancy on routine diagnostic evaluation. Intraductal lesions were removed by ductoscopic extraction. Surgery was undertaken if there were suspicious ductoscopic findings or at the patient's request. Therapeutic efficacy was determined by cannulation success, detection and removal rates, symptom resolution and avoided surgery. RESULTS: Ductoscope introduction was successful in 71 (87 per cent) of 82 patients, with abnormalities visualized in 53 (65 per cent); these were mostly polypoid lesions (29 patients). The lesion was removed in 27 of 34 attempted ductoscopic extractions. Twenty-six (32 per cent) of the 82 patients underwent surgery, whereas surgery was avoided in 56 (68 per cent). After a median follow-up of 17 (range 3-45) months, 40 patients (49 per cent) no longer experienced symptoms of PND, 13 of 34 patients experienced an insufficient therapeutic effect after attempted ductoscopic extraction, and the outcome was unknown in two (2 per cent). Malignancy was diagnosed in four patients (5 per cent); two had been missed at ductoscopy and two at initial surgery after ductoscopy. CONCLUSION: Interventional ductoscopy is technically feasible and may help to avoid surgery in the majority of patients. As endoscopic removal of intraductal lesions is not always possible and malignancy can be the underlying cause of PND, ductoscopic instruments should be further optimized to allow definitive histological diagnosis.

Impact of preoperative evaluation of tumour grade by core needle biopsy on clinical risk assessment and patient selection for adjuvant systemic treatment in breast cancer.

BACKGROUND: Histological characteristics are important when making a decision on adjuvant systemic treatment in breast cancer. Preoperative assessments of core needle biopsy (CNB) specimens are becoming increasingly relevant as novel minimally invasive ablative techniques are introduced, because a surgical specimen is no longer obtained with these methods. The clinical impact of potential underestimation of tumour grade on preoperative CNB on clinical decision-making was evaluated. METHODS: Histological tumour grade was reassessed on CNB and resection specimens from consecutive invasive ductal carcinomas diagnosed between 2010 and 2013. For each patient, the indication for systemic therapy was assessed, based on either CNB or surgical excision, in combination with clinical characteristics and imaging findings. The clinical impact of discordance between tumour grade on CNB versus the resection specimen was assessed. RESULTS: The analysis included 213 invasive ductal carcinomas in 199 patients. Discordance in tumour grade between CNB and the resection specimen was observed in 64 (30.0 per cent) of 213 tumours (κ = 0.53, 95 per cent c.i. 0.43 to 0.63). A decision on adjuvant treatment based on CNB would have resulted in overtreatment in seven (3.5 per cent) and undertreatment in three (1.5 per cent) of 199 patients. In the undertreated patients, incorrect omission of adjuvant systemic treatment would have increased the predicted 10-year mortality rate by 2.6-5.2 per cent and 10-year recurrence rate by 8.2-15.3 per cent based on the online risk assessment tool Adjuvant! CONCLUSION: The substantial discordance in tumour grading between CNB and resection specimens from breast cancer affects the indication for adjuvant therapy in only a small minority of patients with invasive ductal carcinoma. Assessment of tumour grade by CNB is feasible and accurate for the planning of postoperative treatment.

Radiofrequency ablation of small breast tumours: evaluation of a novel bipolar cool-tip application.

BACKGROUND: Although radiofrequency ablation (RFA) is promising for the local treatment of breast cancer, burns are a frequent complication. The safety and efficacy of a new technique with a bipolar RFA electrode was evaluated. METHODS: Dosimetry was assessed ex vivo in bovine mammary tissue, applying power settings of 5-15 W with 10-20 min exposure and 3.0-12.0 kJ to a 20-mm active length bipolar internally cooled needle-electrode. Subsequently, in 15 women with invasive breast carcinoma ≤2.0 cm diameter ultrasound-guided RFA was performed followed by immediate resection. RESULTS: An ablation zone of 2.5 cm was reached in the ex vivo experiments at 15 W at 9.0 kJ administered energy. Histopathology revealed complete cell death in 10 of 13 patients (77%); in 3 patients partial ablation was due to inaccurate probe positioning. In 1 patient a pneumothorax was caused by the probe placement, treated conservatively. No burns occurred. CONCLUSIONS: Ultrasound-guided RFA with a bipolar needle-electrode appears to be a safe local treatment technique for invasive breast cancer up to 2 cm. Ways to improve placement of the probe and direct monitoring of the ablation-effect should be the aim of further research.