INTEND II randomized clinical trial of intraoperative duct endoscopy in pathological nipple discharge

Gui, Gerald; Agusti, Ana; Twelves, Dominique; Tang, Sarah; Mohammed, Kabir; Montgomery, Catherine; Nerurkar, Ashutosh; Osin, Peter; Isacke, Clare M.

doi:10.1002/bjs.10990

Cited by 11 publications

(12 citation statements)

References 32 publications

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“…Sensitivity, specificity, and negative predictive values were similar to previously conducted research in patients with an increased risk for the development of breast cancer. 33 All other results are in line with previous studies conducted. [20][21][22]28,29,31 In recent years, MRI is sometimes used to find the cause of PND.…”

Section: Mando Dyko Filipe Et Alsupporting

confidence: 92%

Interventional Ductoscopy as an Alternative for Major Duct Excision or Microdochectomy in Women Suffering Pathologic Nipple Discharge: A Single-center Experience

Filipe

Waaijer

Pol

et al. 2020

Clinical Breast Cancer

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Ductoscopy is a minimally invasive technique that is currently used to detect, and sometimes remove, lesions that cause pathologic nipple discharge (PND). This study shows that ductoscopy is an alternative for surgery in patients with PND that have negative conventional imagery for breast cancer. Additionally, this study shows that ductoscopy has a high sensitivity, specificity, and negative predictive value for the detection of breast cancer in patients with PND with negative conventional imagery. Introduction: Pathologic nipple discharge (PND) is, after palpable lumps and pain, the most common breast-related reason for referral to the breast surgeon and is associated with breast cancer. However, with negative mammography and ultrasound, the chance of PND being caused by malignancy is between 5% and 8%. Nevertheless, most patients with PND still undergo surgery in order to rule out malignancy. Ductoscopy is a minimally invasive endoscopic technique that enables direct intraductal visualization. The aim of this study was to evaluate (interventional) ductoscopy as an alternative to surgery in patients with negative conventional imaging. Materials and Methods: All patients with PND referred between 2010 and 2017 to our hospital for ductoscopy were retrospectively analyzed. Ductoscopy procedures were performed under local anesthesia in the outpatient clinic. The follow-up period was at least 3 months, and the primary outcome was the number of prevented surgical procedures. Furthermore, we evaluated possible complications after ductoscopy (infection and pain). Results: A total of 215 consecutive patients undergoing ductoscopy were analyzed. In 151 (70.2%) patients, ductoscopy was successful. In 102 procedures, an underlying cause for PND was visualized, of which 34 patients could be histologically proven and 82 patients treated. Sixty of the 215 patients were eventually operated, 8 owing to suspicious findings during ductoscopy, 42 owing to persistent PND, and 10 because of recurrent PND. In 7 patients, a malignancy was found (5 of them classified as suspicious at dusctoscopy). No serious side effects were seen. Conclusion: Ductoscopy can be safely used as an alternative for surgery in the workup for PND.

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Section: Mando Dyko Filipe Et Alsupporting

confidence: 92%

Interventional Ductoscopy as an Alternative for Major Duct Excision or Microdochectomy in Women Suffering Pathologic Nipple Discharge: A Single-center Experience

Filipe

Waaijer

Pol

et al. 2020

Clinical Breast Cancer

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“…No statistically significant changes were observed in the overall scores of the Breast-Q, SF-36 and EQ-5D-5L questionnaires at baseline compared to 2 weeks, 3 and 6 months after ductoscopy, indicating that ductoscopy does not negatively influence QOL. These findings further support the use of ductoscopy, which is performed more and more for both diagnostic and therapeutic purposes [26,34,35]. Additionally, this study showed that the all domains of Breast-Q, and EQ-5D-5L were stable over time and are thereby useful questionnaires for PND patients, while SF-36 was as a whole less useful and would require modifications.…”

Section: Discussionsupporting

confidence: 67%

“…Ductoscopy is often used to detect the cause underlying PND, which in the majority of cases is a benign lesion [23,35,[42][43][44][45]. A meta-analysis showed that ductoscopy has a sensitivity of 94% in detecting intraductal lesions of any type, but cannot reliably discriminate between benign and malignant lesions [46].…”

Section: Discussionmentioning

confidence: 99%

Patient-reported outcomes of ductoscopy procedures for pathologic nipple discharge

et al. 2020

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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.

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“…However, ductoscopy is highly suitable for detecting benign lesions causing PND. 46,47,50,59,73,79 However, without histologic sampling of the lesions found, ductoscopy images alone cannot permit reliable discrimination between benign and malignant causes; endoscopic sampling during ductoscopy is not possible; and surgery may still be warranted to exclude malignancy. 24 Ductoscopy is not a cheap technique, like MRI is, so it may be especially useful when conventional imaging is negative.…”

Section: Discussionmentioning

confidence: 99%

Network Meta-analysis for the Diagnostic Approach to Pathologic Nipple Discharge

Filipe

Patuleia

Jong

et al. 2020

Clinical Breast Cancer

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Pathologic nipple discharge (PND) is one of the most common breast-related complaints for referral because of its supposed association with breast cancer. The aim of this network meta-analysis (NMA) was to compare the diagnostic efficacy of ultrasound, mammogram, cytology, magnetic resonance imaging (MRI), and ductoscopy in patients with PND, as well as to determine the best diagnostic strategy to assess the risk of malignancy as cause for PND. Cochrane Library, PubMed, and Embase were searched to collect relevant literature from the inception of each of the diagnostic methods until January 27, 2020. The search yielded 1472 original citations, of which 36 studies with 3764 patients were finally included for analysis. Direct and indirect comparisons were performed using an NMA approach to evaluate the combined odd ratios and to determine the surface under the cumulative ranking curves (SUCRA) of the diagnostic value of different imaging methods for the detection of breast cancer in patients with PND. Additionally, a subgroup meta-analysis comparing ductoscopy to MRI when conventional imaging was negative was also performed. According to this NMA, sensitivity for detection of malignancy in patients with PND was highest for MRI (83%), followed by ductoscopy (58%), ultrasound (50%), cytology (38%), and mammogram (22%). Specificity was highest for mammogram (93%) followed by ductoscopy (92%), cytology (90%), MRI (76%), and ultrasound (69%). Diagnostic accuracy was the highest for ductoscopy (88%), followed by cytology (82%), MRI (77%), mammogram (76%), and ultrasound (65%). Subgroup meta-analysis (comparing ductoscopy to MRI when ultrasound and mammogram were negative) showed no significant difference in sensitivity, but ductoscopy was statistically significantly better with regard to specificity and diagnostic accuracy. The results from this NMA indicate that although ultrasound and mammogram may remain low-cost useful first choices for the detection of malignancy in patients with PND, ductoscopy outperforms most imaging techniques (especially MRI) and cytology.

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INTEND II randomized clinical trial of intraoperative duct endoscopy in pathological nipple discharge

Cited by 11 publications

References 32 publications

Interventional Ductoscopy as an Alternative for Major Duct Excision or Microdochectomy in Women Suffering Pathologic Nipple Discharge: A Single-center Experience

Interventional Ductoscopy as an Alternative for Major Duct Excision or Microdochectomy in Women Suffering Pathologic Nipple Discharge: A Single-center Experience

Patient-reported outcomes of ductoscopy procedures for pathologic nipple discharge

Network Meta-analysis for the Diagnostic Approach to Pathologic Nipple Discharge

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