Prospective observational study on the safety of an original fiducial marker insertion for radiotherapy in gynecological cancer by a simple method
Prospective observational study on the safety of an original fiducial marker insertion for radiotherapy in gynecological cancer by a simple method
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DOI：
10.1093/jrr/rrz070
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发表时间：
2019-11-01
影响因子：
2
通讯作者：
Sasaki, Ryohei
中科院分区：
文献类型：
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作者：
Sekii, Shuhei;Tsujino, Kayoko;Sasaki, Ryohei
我们的观察性研究旨在通过使用简单的插入方法验证我们的原始钛基准标记在妇科癌症中的安全性。我们前瞻性评价了接受钛标记物插入手术的妇科癌症患者的安全性。植入钛标记的决定由每位放射肿瘤学家自行决定。通过将用于手术的结扎夹切割成3-6 mm的片来制造基准标记，然后进行灭菌。我们将含有标记物的18号注射针插入，然后通过22号Cattelan针或形状记忆合金丝将标记物挤出到肿瘤或肿瘤附近的组织中。植入后3个月内的严重并发症根据美国国家癌症研究所的不良事件通用术语标准4.0版进行评分。2016年8月至2018年12月，我们招募了46例患者。46例中，44例接受了植入术。中位年龄为58.5岁。最常见的原发部位是宫颈。2名患者在植入后发生标记分离。未观察到3级或更高级别的并发症。我们的原始钛基准标记的简单插入技术耐受性良好。
Our observational study aimed to verify the safety of our original titanium fiducial markers in gynecological cancer by using a simple insertion method. We prospectively evaluated the safety in patients with gynecological cancer who had undergone our insertion procedure of the titanium markers. The decision to implant a titanium marker was at the discretion of each radiation oncologist. The fiducial markers were manufactured by severing ligating clips for surgery into 3-6 mm pieces and were sterilized thereafter. We inserted an 18-gauge injection needle containing the marker before the marker was extruded by a 22-gauge Cattelan needle or shape memory alloy wire into the tumor or tissues close to the tumor. Severe complications within 3 months after implantation were scored according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 4.0. Between August 2016 and December 2018, we enrolled 46 patients. Of 46, 44 underwent implantation. The median age was 58.5 years. The most common primary site was the cervix. Two patients experienced detachment of the markers after implantation. No Grade 3 or higher level of complications was observed. Our simple insertion technique for original titanium fiducial markers was well-tolerated.