Geng Lidan, Wu Rong, Hu He, Zhao Yu, Fan Lingli, Zhao Zhenhua, Liao Dongbiao, Li Musheng, Xiang Miao, Ma Ying, Du Xiaobo
Department of Oncology, Mianyang Central Hospital, Mianyang Department of Oncology, Affiliated Hospital of North Sichuan Medical College, Nan Chong Department of Oncology, Yan Ting County Cancer Hospital, Yan Ting Department of Oncology Department of Radiology Department of Scientific Research and Education, Mianyang Central Hospital, Mianyang, People's Republic of China.
Medicine (Baltimore). 2018 May;97(18):e0668. doi: 10.1097/MD.0000000000010668.
Esophageal fistula is a serious and common complication of radiotherapy for esophageal cancer. Therefore, early diagnosis and treatment is necessary. Because of side effect of barium esophagography, it cannot be used to screening esophageal fistula during radiotherapy. Meglumine diatrizoate is an ionic contrast agent, its adverse reactions were rarely seen when it was used in the body cavity. The purpose of this trial is identified the sensitivity and specificity of oral meglumine diatrizoate in an esophagogram for screening esophageal fistula during radiotherapy.
METHODS/DESIGN: This trial was a prospective, multicenter, diagnostic clinical trial. A total of 105 patients with esophageal cancer will swallowed meglumine diatrizoate and underwent a radiographic examination weekly during radiotherapy, medical personnel observed the esophageal lesions to determine whether an esophageal fistula formed. If an esophageal fistula was observed, esophagofiberoscopy and/or computer tomography was used to further confirm the diagnosis. And the sensitivity and specificity of meglumine diatrizoate should be calculated for screening esophageal fistula during radiotherapy.
To our knowledge, this study protocol is the first to identify the sensitivity and specificity of oral meglumine diatrizoate in an esophagogram for screening esophageal fistula during radiotherapy. If oral meglumine diatrizoate can be used to screening esophageal fistula, more patients will benefit from early detection and treatment.
食管瘘是食管癌放疗常见的严重并发症。因此，早期诊断和治疗很有必要。由于食管钡餐造影的副作用，其不能用于放疗期间食管瘘的筛查。泛影葡胺是一种离子型造影剂，在体腔使用时不良反应少见。本试验的目的是确定口服泛影葡胺食管造影在放疗期间筛查食管瘘的敏感性和特异性。
方法/设计：本试验是一项前瞻性、多中心诊断性临床试验。共105例食管癌患者在放疗期间每周口服泛影葡胺并接受影像学检查，医务人员观察食管病变以确定是否形成食管瘘。若观察到食管瘘，则采用食管纤维内镜检查和/或计算机断层扫描进一步确诊。并计算泛影葡胺在放疗期间筛查食管瘘的敏感性和特异性。
据我们所知，本研究方案首次确定了口服泛影葡胺食管造影在放疗期间筛查食管瘘的敏感性和特异性。如果口服泛影葡胺可用于筛查食管瘘，更多患者将受益于早期检测和治疗。
