Makineli S, Filipe M D, Euwe F, Sakes A, Dankelman J, Breedveld P, Vriens M R, van Diest P J, Witkamp A J
Department of Surgical Oncology, University Medical Center, Utrecht, The Netherlands.
Department of Medical Technology and Clinical Physics, University Medical Center, Utrecht, The Netherlands.
Int J Surg Protoc. 2022 Sep 1;26(1):73-80. doi: 10.29337/ijsp.180. eCollection 2022.
Ductoscopy is a minimally invasive micro-endoscopic approach for direct visualization of intraductal lesions of the breast. Challenges of ductoscopy are low sensitivity for detecting malignancy, the lack of a proper intraductal biopsy device, and adequate treatment of intraductal lesions. This study will analyze three new approaches to enhance the effectiveness of interventional ductoscopy in patients with (premalignant) intraductal lesions: narrow-band imaging (NBI), new intraductal biopsy tools, and intraductal laser ablation. The main aims of the present study are to improve diagnostic accuracy and therapeutic efficacy of interventional ductoscopy in patients with pathological nipple discharge (PND) and to explore the feasibility of the new approaches in diagnosing and removing intraductal precursor lesions.
This prospective, single-center, diagnostic feasibility study will include two patient groups. : women with PND with no radiological suspicion for malignancy. : women undergoing mastectomy (preventive or therapeutic). The primary endpoints for both groups are the technical feasibility of NBI ductoscopy, intraductal biopsy, and laser ablation, and as secondary endpoint the number of diagnosed and successfully treated intraductal lesions.
Enhanced ductoscopy with NBI, intraductal biopsy, and laser ablation could prevent unnecessary surgery in patients with PND.
This study was approved by the Medical Research Ethics Committee UMC Utrecht in The Netherlands (METC protocol number 21-688/H-D). The results of this study will be published in peer-reviewed journals and presented at national and international conferences.
导管镜检查是一种微创显微内镜方法，用于直接观察乳腺导管内病变。导管镜检查面临的挑战包括检测恶性肿瘤的敏感性低、缺乏合适的导管内活检设备以及对导管内病变的充分治疗。本研究将分析三种新方法，以提高介入性导管镜检查对（癌前）导管内病变患者的有效性：窄带成像（NBI）、新型导管内活检工具和导管内激光消融。本研究的主要目的是提高介入性导管镜检查对病理性乳头溢液（PND）患者的诊断准确性和治疗效果，并探索这些新方法在诊断和切除导管内前驱病变方面的可行性。
这项前瞻性、单中心诊断可行性研究将包括两个患者组。：无恶性肿瘤放射学怀疑的PND女性。：接受乳房切除术（预防性或治疗性）的女性。两组的主要终点是NBI导管镜检查、导管内活检和激光消融的技术可行性，次要终点是诊断和成功治疗的导管内病变数量。
采用NBI、导管内活检和激光消融增强导管镜检查可以避免PND患者进行不必要的手术。
本研究已获得荷兰乌得勒支大学医学中心医学研究伦理委员会批准（METC协议编号21-688/H-D）。本研究结果将发表在同行评审期刊上，并在国内和国际会议上展示。
