DUCTOSCOPY

DUCTOSCOPY

Publications

NEW TECHNOLOGY

RELEVANT ARTICLES

RELEVANT ARTICLES

Publications about Ductoscopy

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

Filipe, Mando & Waaijer, Laurien & Pol, C.C. & Diest, Paul & Witkamp, Arjen. 2020

Abstract: 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.

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Detection of breast cancer precursor lesions by autofluorescence ductoscopy

Waaijer, Laurien & Filipe, Mando & Simons, Janine & Pol, Carmen & Boorder, Tjeerd & Diest, Paul & Witkamp, Arjen. 2020

Abstract: Autofluorescence is an image enhancement technique used for the detection of cancer precursor lesions in pulmonary and gastrointestinal endoscopy. This study evaluated the feasibility of addition of autofluorescence to ductoscopy for the detection of intraductal breast cancer precursor lesions.

An autofluorescence imaging system, producing real-time computed images combining fluorescence intensities, was coupled to a conventional white light ductoscopy system. Prior to surgery, ductoscopy with white light and autofluorescence was evaluated under general anaesthesia in women scheduled for therapeutic or prophylactic mastectomy. Endoscopic findings in both modes were compared, marked and correlated with histology of the surgical specimen.ResultsFour breast cancer patients and five high-risk women, with a median age of 47 years (range 23–62) were included. In autofluorescence mode, two intraductal lesions were seen in two breast cancer patients, which had an increase in the red-to-green fluorescence intensity compared with the surrounding tissue. One lesion had initially been missed by white light ductoscopy but was clearly visible in subsequent autofluorescence mode. One endoscopic finding was classified as suspicious by white light, but was negative in autofluorescence mode and showed normal histology. This study demonstrates for the first time the in vivo feasibility of autofluorescence ductoscopy to detect pathologically confirmed breast cancer precursor lesions in both breast cancer patients and high-risk women that were occult under white light.

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Mammary ductoscopy: Past, present, and future

Bernadette, Pereira & Mokbel, Kefah. 2005

Abstract: Mammary ductoscopy (MD) allows direct visual access to the mammary ducts, using fiberoptic microendoscopes inserted through the ductal opening onto the nipple surface. Therefore it has a potential role in the diagnosis and treatment of intraductal breast disease.

This article describes the anatomy of the mammary ductal system, the early beginnings of MD, its ongoing evolution, and the need for further development for its future usage in increasing clinical indications. MD is a useful diagnostic adjunct in patients with pathological nipple discharge (PND) and can guide duct excision surgery. However, its potential use in the early detection of breast cancer, in guiding breast-conserving surgery (BCS) for cancer, and in the therapeutic ablation of intraductal disease, as well as in guiding risk-reducing strategies among high-risk women, requires further research and evaluation. The development of a biopsy kit that obtains adequate microbiopsy samples for histological diagnosis under direct visualization will enhance the use of this technique by breast surgeons and radiologists. Future developments also include combining MD with molecular diagnostic markers and optical biopsy systems for the diagnosis of premalignant and early malignant disease, and combining MD with radiofrequency for curative ablation of intraductal lesions.

RELEVANT PUBLICATION

Fiberoptic Ductoscopy of the Breast: A New Diagnostic Procedure for Nipple Discharge

Okazaki, Akira & Okazaki, Minoru & Asaishi, K & Satoh, Hitoshi & Watanabe, Yasuyoshi & Mikami, Toshihiko & Toda, Kazunori & Okazaki, Yurie & Nabeta, Kensuke & Hirata, Koichi. 1991

Abstract: A fiberoptic ductoscopy system was successfully developed by means of which we were able to observe the duct cavity of the breast. Two kinds of silicafiberscopes with outer diameters 0.80 and 0.45 mm were used in the present study. Fiberoptic ductoscopy was applied to 52 ducts in 46 patients with nipple discharge for whom no tumor was palpable; the intraductal appearance could be observed in 47 ducts from 41 patients (90.3%).

Fourteen ducts from 13 patients were operated upon and were histologically diagnosed as carcinoma (four cases), intraductal papilloma (nine ducts from eight patients) and mastitis (one case). The internal surface of a normal duct was lustrous and smooth. Cancer growing on the surface of a duct wall appeared white and was slightly elevated, forming a bridging structure. The intraductal papillomas formed intraductal solid nodules, being yellow in most cases and red at the site of hemorrhage. Fiberoptic ductoscopy can be used to recognize the growth of minute intraductal lesions in cases of nipple discharge. Clinical endoscopic diagnosis for minute intraductal lesions will make an important contribution to the early detection of cancer and the evaluation of nipple involvement in intraductal carcinoma.

RELEVANT PUBLICATION

Diagnostic value of ductoscopy in the diagnosis of nipple discharge and intraductal proliferations in comparison to standard methods

Grunwald, Susanne & Heyer, Hans & Paepke, Stefan & Schwesinger, Günther & Schimming, Anette & Hahn, Markus & Thomas, Anke & Jacobs, Volker & Ohlinger, Ralf. 2007

Abstract: Background. Ductoscopy is gaining increased importance in the diagnosis of nipple discharge of unclear origin and intraductal proliferation. For this reason we compared its diagnostic value and feasibility to standard diagnostic methods. Material and methods. Ductoscopy was compared to mammography, galactography, sonography, magnetic resonance imaging (MRI), nipple smear, fine needle aspiration cytology (FNAC), and high-speed core biopsy; feasibility, sensitivity, and specificity were investigated for each method.

Results. 71 ductoscopies were evaluated, which were followed up by open biopsies. Here, 3 invasive and 8 ductal carcinomas in situ were found, as well as 3 atypical ductal hyperplasias, 44 papillomas/papillomatoses, and 13 benign findings. Feasibility of ductoscopy was in this series 100%. Duct sonography showed the highest sensitivity (67.3%), followed by MRI (65.2%), galactography (56.3%), ductoscopy (55.2%), and FNAC (51.9%). The highest specificity was shown by FNAC, core biopsy, and galactography (each 100.0%), followed by mammography (92.3%), nipple smear (77.8%), ductoscopy, and duct sonography (each 61.5%); the lowest specificity was displayed by MRI (25.0%). Conclusion. The results confirm that ductoscopy can be performed within the same range of sensitivity and specificity as other techniques. In order to make conclusive statements about ductoscopy, especially in order to precisely define the indications for this method, a prospective multicenter study was initiated.

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Interventional ductoscopy in patients with pathological nipple discharge.

Waaijer L, van Diest PJ, Verkooijen HM, Dijkstra NE, van der Pol CC, Borel Rinkes IH, Witkamp AJ. 2015

Abstract: 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.

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

Waaijer L, Simons JM, Borel Rinkes IH, van Diest PJ, Verkooijen HM, Witkamp AJ. 2016

Abstract: 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.

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

Filipe MD, Patuleia SIS, Vriens MR, van Diest PJ, Witkamp AJ. 2021

Abstract: Introduction. Pathological nipple discharge (PND) is a common breast-related complaint for referral to a surgical breast clinic because of its association with breast cancer. The aim of this meta-analysis was to compare the diagnostic efficacy of magnetic resonance imaging (MRI) and ductoscopy in patients with PND. Additionally, we determined the most cost-efficient strategy for the treatment of PND and the detection of breast cancer in PND patient without radiological suspicion for malignancy.

Materials and methods. PubMed and EMBASE were searched to collect the relevant literature from the inception of both diagnostic methods until January 27th 2020. The search yielded 815 original citations, of which 10 studies with 894 patients were finally included for analysis. Costs of ductoscopy, MRI and duct excision surgery were obtained from the UMC Utrecht as established in the year 2019. These costs included: medical personnel, overhead costs, material costs and sterilisation costs. Results. The meta-analysis showed no significant difference in sensitivity between ductoscopy (44%) and MRI (76%) for the detection of malignancy in patients with PND. However, ductoscopy (98%) had a statistically significantly higher specificity than MRI (84%). Individual costs were €1401.33, €822.13 and €6494.27 for ductoscopy, MRI and duct excision surgery, respectively. Full diagnostic strategy involving ductoscopy was on average €1670.97, while with MRI it was €2070.27. Conclusion. Patients undergoing MRI are more often (false) positive which more often leads to duct excision surgery referrals compared to ductoscopy. This makes ductoscopy significantly more cost-effective compared MRI in patients with PND without radiological suspicion for malignancy.

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Patient-reported outcomes of ductoscopy procedures for pathologic nipple discharge

Filipe MD, Simons JM, Moeliker L, Waaijer L, Vriens MR, van Diest PJ, Witkamp AJ. 2021

Abstract: 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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Ductoscopy for pathologic nipple discharge

Waaijer L, van Diest PJ, Van der Pol CC, Verolme B, Hennink A, Witkamp AJ. 2013

Pathologic nipple discharge is a symptom that frequently causes female patients to visit the outpatient breast clinic. In the vast majority of cases, the symptom is caused by a benign intraductal laesion. The options for diagnosis and treatment have long been limited; surgery was not infrequently the treatment of choice. With the advent of breast ductoscopy, a micro-endoscopic procedure, it is possible to visualise abnormalities in the ductal system. 

Tissue for histopathological investigation can be retrieved from the duct and the condition can be treated. The patient with nipple discharge is consequently prevented from having to undergo an invasive and fairly ‘blindly’ executed procedure under general anaesthesia. The miniscule dimensions of the duct in which the technique is carried out pose the greatest challenge to the further development of the ductoscope.

RELEVANT PUBLICATION

Design of a Novel Miniature Breast Biopsy Needle for Ductoscopy

Sakes, Aimee & Snaar, Kevin & Smit, Gerwin & Witkamp, Arjen & Breedveld, Paul. 2018

The majority of the benign and malignant lesions in the breast arise from the ductal epithelium and terminal ductlobular unit. A minimally invasive procedure called ductoscopy is able to visualize these lesions as it inspects the ductal epithelium using a small micro-endoscope.

Unfortunately, it is currently challenging to obtain a tissue sample during ductoscopy and reach the most distal duct. Methods. In this study we have, therefore, developed a novel miniature (∅1.2 mm) biopsy needle that can be used during ductoscopy. This biopsy needle consists of two coaxial counter-rotating hollow blades with a distal cutout to resect lesions from the ductal wall. Three cutouts were manufactured resulting in a beveled, straight, and reverse-beveled blade. The blades were actuated using a novel mechanism containing two helical paths that allows for the counter-rotating motion of the blades at different velocities. In a proof-of-principle experiment, the performance of the biopsy needle was evaluated using a polymeric duct model and gelatin tissue phantom. Results. During the experiment, the straight and reverse-beveled blades were able to obtain a sufficiently large tissue sample for histopathological examination. Based on these promising results, a second experiment was performed in which the micro-endoscope was integrated in the needle and we were able to take a biopsy from a chicken breast. Conclusions. In a future clinical instrument, the biopsy needle will be miniaturized and optimized to allow for an efficient, safe, and effective intraductal biopsy procedure without the need for an invasive excisional biopsy procedure.

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