胆管狭窄综合症无肿块综合征的胆道刷检可以获得大约50%的敏感性来诊断胆管癌。我们进行了一项多中心随机交叉试验，比较侵袭性的Infinity刷和标准的RX细胞学刷。目的是敏感性诊断胆管癌和细胞丰富度。共纳入51名患者，分别用这两种刷子交替进行胆道刷检。无论使用哪种刷子，细胞学材料都是掩盖的。主要终点是敏感性诊断胆管癌，次要终点是每种刷子获取的细胞丰富度。通过细胞丰富度的定量来确定哪种刷子更有效。最终诊断为胆管癌（n=43，84%），良性（n=7，14%）和不确定性（1例）。Infinity刷对于胆管癌的敏感性为34/43（79％），而RX细胞学刷为29/43（67％）（p=0.096）。Infinity刷在31 / 51（61％）案例中获得大量导管内上皮细胞（CEC），而RX细胞学刷仅在10 / 51（20％）案例中获得大量CEC（p <0.001）。在细胞丰富度定量方面，Infinity刷在28 / 51个案例中（51％）表现远好于RX细胞学刷，而RX细胞学刷在4 / 51个案例中（8％）表现远好于Infinity刷（p <0.001）。结论述：该随机交叉试验表明，在胆管狭窄综合症无肿块综合征的情况下，Infinity刷在敏感性诊断胆管癌方面并不比RX细胞学刷显著更有效，但确实允许更高的细胞丰富度。 ClinicalTrials.gov识别号：NCT04251013。Thieme保留所有权利。

Diagnosis of cholangiocarcinoma in case of biliary stricture without mass syndrome is obtained by biliary brushing with approximately 50% sensitivity. We performed a multicenter randomized crossover trial comparing the aggressive Infinity brush with the standard RX Cytology Brush. The aims were sensitivity for cholangiocarcinoma diagnosis and cellularity abundance.51 patients were included. Biliary brushing was performed consecutively with each brush, in a randomized order. Cytological material was studied in a blinded manner concerning the brush. The primary endpoint was sensitivity for cholangiocarcinoma diagnosis, and the secondary endpoint was the abundance of the cellularity obtained with each brush. Cellularity was quantified, in order to determine if one brush strongly outperformed the other.Final diagnosis was cholangiocarcinoma (n = 43, 84%), benign (n = 7, 14%) and indeterminate (1 case). Sensitivity for cholangiocarcinoma was 34/43 (79%) for the Infinity brush versus 29/43 (67%) for the RX Cytology Brush (p = 0.096). Cellularity was rich in 31/51 (61%) cases with the Infinity brush and in 10/51 (20%) cases with the RX Cytology Brush (p < 0.001). In terms of cellularity quantification, the Infinity brush strongly outperformed the RX Cytology Brush in 28/51 cases (51%), while the RX Cytology Brush strongly outperformed the Infinity brush in 4/51 cases (8%) (p < 0.001). Conclusions This randomized crossover trial shows that the Infinity brush is not significantly more effective than the RX Cytology Brush for biliary stenosis without mass syndrome in terms of sensitivity for cholangiocarcinoma but does allow significantly higher cellularity abundance. ClinicalTrials.gov ID: NCT04251013.Thieme. All rights reserved.