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目的:探索内镜下球囊扩张术联合胆道细胞刷检应用于胆管癌的诊断价值。方法:单中心前瞻性研究,本研究在华中科技大学同济医学院附属武汉市中心医院进行,总结2018年1月-2020年1月期间影像学(CT或MRI)提示胆管恶性狭窄可能或原因不明胆管狭窄并同意行内镜逆行胰胆管造影诊治的患者的临床资料及随访情况。所纳入研究患者均行内镜下胆管狭窄球囊扩张术,并于球囊扩张前后分别进行细胞刷检术,扩张前留取病理组织为对照组样本,扩张后留取病理组织为试验组样本。试验组、对照组样本经同一名病理专业副主任医师阅片后提出病理诊断意见。若有癌细胞或显著异型细胞发现提示刷检阳性。若未见癌细胞或异型细胞则提示刷检阴性。阴性患者中结合临床仍高度考虑胆管癌且同意手术,术后大体标本证实为恶性的考虑刷检假阴性;难以判断胆管癌患者经随访2个月有进展考虑刷检假阴性。2个月随访无进展,暂考虑胆管良性狭窄可能。应用优势性检验(McNemar检验)分析试验组与对照组之间是否存在差异。结果:共纳入符合条件的研究病例39例,男性26例,女性13例,年龄(68.0±5.2)岁。经细胞学检测、手术病理及临床随访最终明确诊断胆管癌35例。对照组刷检阳性17例,细胞刷检敏感率48.6%(17/35),试验组刷检阳性26例,细胞刷检敏感率74.2%(26/35)。另外有2例患者对照组刷检阳性,试验组刷检阴性。合计对照组及试验组刷检阳性共28例,细胞刷检敏感率80.0%(28/35),两组比较差异有统计学意义(n P<0.05)。n 结论:内镜下球囊扩张术联合细胞刷检可提高胆管癌的病理诊断灵敏度,球囊扩张前后分别进行细胞刷检可提高诊断灵敏度。“,”Objective:To study the combined use of endoscopic balloon dilation with endoscopic biliary brushings in diagnosis of bile duct strictures.Methods:A prospective single center study was conducted at the Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology. All patients with suspected malignant bile duct strictures shown on CT or MRI imaging from January 2018 to January 2020 were reviewed. All patients gave informed consent to the endascopic retrograde cholangiopancreatography procedures. Their clinical and follow-up data were analyzed. All patients underwent endoscopic balloon dilation of bile duct strictures. Before and after balloon dilation, biliary brush cytology was performed, and the results were used to classify the patients into the control group and the experimental group. Pathological examination of the brush cytology samples was carried out by a single chief pathologist. Presence of cancer cells or significant heterogeneous cells indicated a positive brush cytology test. Negative patients who still highly consider cholangiocarcinoma and agree to surgery and whose gross specimen is confirmed to be malignant after surgery should be considered as false negative by brush examination; it is difficult to judge that patients with cholangiocarcinoma have progress after 2 months of follow-up should be considered as false negative by brush examination. Any progression of disease indicated that the brush test was wrong and the test was again classified as false negative. Only when there was no progression of strictures was the possibility of a benign biliary stricture being considered. The advantage test (McNemar test) was used to analyze the difference between the two diagnostic methods.Results:Of 39 patients who were included in this study, there were 26 males and 13 females, with an age of (68.0 ± 5.2) years. Cholangiocarcinoma was diagnosed by histopathology, surgery or at 2 months follow-up in 35 patients. In the control group, 17 patients had a positive brush test (sensitivity rate was 48.6%, 17/35). In the experimental group, 26 patients had a positive brush test (sensitivity rate was 74.2%, 26/35). In addition, 2 patients in the control group had a positive brush test, while in the experimental group, a negative brush test. A total of 28 patients were positive in the two groups. The sensitivity rate of the brush test was 80.0% (28/35). There were significant differences between the two groups (n P<0.05).n Conclusion:Endoscopic balloon dilation combined with endoscopic biliary brushings improved the sensitivity of pathological diagnosis of cholangiocarcinoma, and endoscopic biliary brushings before and after balloon dilation improved the sensitivity of diagnosis.