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Randomized Controlled Trial
. 2022 Feb 28;47(2):238-243.
doi: 10.11817/j.issn.1672-7347.2022.210388.

Application value of a new lesion positioning stickers in breast lesion surface localization

[Article in English, Chinese]
Rong Tan  1 , Lijuan Pan  2 , Qi Tang  3 , Hui Chen  4 , Yaling Jiang  5 , Nina Li  6
Affiliations
Randomized Controlled Trial

Application value of a new lesion positioning stickers in breast lesion surface localization

[Article in English, Chinese]
Rong Tan et al. Zhong Nan Da Xue Xue Bao Yi Xue Ban. .

Abstract
in English, Chinese

Objectives: Accurate breast lesion surface localization can guarantee accurate biopsy and local treatment. But there is no guideline to regular equipment and methods for the localization of breast lesions. The conventional non-invasive localization method is marker-based localization. The advantages of this method are simple and efficient. The disadvantages are that markers disappear easily under coupling agents; the positioning length of markers cannot last long on skin; and healthcare associated infection due to many patients using the same marker pen is potentially unavoidable. Breast lesion sticker (called sticker for short) is a new-type localization medical instrument in 2020. Our study aims to explore the clinical value of a new lesion stickers in breast lesion surface localization via comparison of the sticker and marker pen localization methods.

Methods: This was a prospective cohort study. It was conducted in 67 patients who needed breast lesion surface localization before biopsy. The patients were randomly assigned into 2 groups. One group of patients used marker pen to mark breast lesion surface location by ultrasonography. The other group of patients used stickers. Patients labeled with markers on skin were swabbed agents before marking. Then the markers were checked by ultrasound scan. If the surface positions of breast lesion were not correct, the above procedure was repeated. In the sticker group, the stickers were released synchronously after the lesions were detected by ultrasound scan. Then locations were checked via scanning hole. If the surface positions of breast lesion were not correct, the above procedure was repeated. The accuracy of positioning, the length of positioning time and satisfaction of patients between the 2 groups were compared. The length of positioning time was calculated from the time when ultrasound detected the lesion to the time when the surface position of breast lesion was confirmed. The total score of patients' satisfaction was 5 points according to Service Quality Evaluation of SERVQUAL Scale, including sonographers' service attitude and their technical proficiency, other medical staffs' service attitude and their technical proficiency, hospital service procedures, positioning comfort, and positioning effects.

Results: All 67 patients were females, aged 18-66 (39.73±13.10). There were 35 patients in the marker pen group and 32 patients in the sticker group. The time length of group used marker pen to localization was 22-88 (52.20±2.90) s, and the sticker group was 3-15 (9.22±0.58) s in length. The length of positioning time for the stickers was significantly shorter than that of the marker (P<0.01). Both methods were accurate in the surface localization of lesions before operation. The total scores of patients' satisfaction was 4-5 (4.92±0.02) in the stickers group, and 1-5 (3.35±0.10) in the marker pen group. The patients' satisfaction scores with the sticker were significantly higher than those with the marker pen (P<0.01). The length of positioning time and patients' satisfication scores for sonographer with 20 years' working experience were shorter and higher than those of sonographer with 10 years' working experience, respectively (both P<0.05).

Conclusions: The new breast lesion positioning stickers have more advantages than the marker pen in localization efficiency. It could reduce the workload of medical workers and increase patients' satisfaction to some extent. The stickers can be used not only in the breast lesions surface localization, but also in the skin location of pleural effusion and ascites, the skin location of surface masses, the skin location of thyroid nodule, and many other clinical marker areas, to further expand the scope of clinical application and value of the stickers.

目的: 术前精准定位是确保乳腺病灶活体组织检查甚至是局部治疗位置准确的前提。目前对乳腺病灶的定位缺乏统一的器材和方法。常规的无创定位方式是记号笔标记定位。其优点是简单快捷；但存在记号容易丢失、位置锁定时间短及多个患者用同一支记号笔定位存在潜在院内感染风险等不足。乳腺病灶定位贴(以下简称定位贴)是2020年成果转化后的新型医疗耗材。本研究旨在通过比较定位贴和记号笔两种不同定位方式在乳腺病灶中的应用，探讨这种新型的定位贴在乳腺病灶体表定位中的应用价值。方法: 本研究为前瞻性队列研究。随机选取67例乳腺活体组织检查术前定位的患者，在超声引导下进行病灶定位。根据患者入选的先后顺序，参照随机对照表分配的定位方式分为记号笔标记组和定位贴组。在超声引导下分别对患者的病灶进行记号笔标记和定位贴标记。记号笔标记组患者在超声发现病灶后先擦拭耦合剂再进行标记，然后采用超声探查标记点位置是否准确，如不准确则重复之前操作。定位贴组在超声发现病灶后同步释放定位贴，固定定位贴后，采用超声仪在定位标记孔处重复探查位置是否准确，如不准确则重复之前操作。比较和分析常用的记号笔定位标记和定位贴标记在乳腺病灶病例中的定位准确性、定位时长及患者满意度差异。定位时间的计算为从发现乳腺病灶后开始定位到确定位置的时长。患者满意度评分参考SERVQUAL量表设计总分为5的简易量表，包括整个定位流程中超声科医生服务态度及技术熟练度、其他医务人员服务态度及技术熟练度、医院服务流程、定位舒适度及定位效果5个方面。结果: 67例乳腺疾病患者均为女性，年龄18~66(39.73±13.10)岁。记号笔标记组35例和定位贴组32例。记号笔标记定位时长为22~88(52.20±2.90) s，定位贴定位时长为3~15(9.22±0.58) s，定位贴定位耗时明显低于记号笔标记定位(P<0.01)。两种定位方式对病灶的术前定位准确性都较好。采用定位贴定位的患者满意度为4~5(4.92±0.02)分；采用记号笔标记定位的患者满意度为1~5(3.35±0.10)分，采用定位贴定位的患者满意度明显高于记号笔标记定位者(P<0.01)。工作20年的医生定位时长比工作10年者短，患者满意度评分高(均P<0.05)。结论: 定位贴定位较记号笔标记在定位效率上更有优势，不仅能减轻超声科工作者的工作量，而且可避免患者交叉感染传染性疾病，提高患者的满意度。定位贴不仅可用于乳腺病灶的定位，还可以尝试应用于胸腔积液腹水、浅表肿块及甲状腺结节定位等诸多临床记号笔定位领域，进一步拓宽定位贴的临床应用范围。.

Keywords: breast lesion positioning stickers; lesion; localization; ultrasonography.

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Conflict of interest statement

作者声称无任何利益冲突。

Figures

图1
图1
不同定位方式完成的效果 Figure 1 Effect of different positioning methods A: Marker pen localization; B: Sticker localization.
图2
图2
纤维腺瘤在定位贴下的声像图 Figure 2 Sonography of fibroadenoma under guidance of sticker localization
图3
图3
不同方式定位时长的比较 Figure 3 Comparison of different ways of localization
See this image and copyright information in PMC

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