Tanoue Kojiro, Maruyama Hirotsugu, Ishikawa-Kakiya Yuki, Kinoshita Yosuke, Hayashi Kappei, Yamamura Masafumi, Ominami Masaki, Nadatani Yuji, Fukunaga Shusei, Otani Koji, Hosomi Shuhei, Tanaka Fumio, Kamata Noriko, Nagami Yasuaki, Taira Koichi, Watanabe Toshio, Fujiwara Yasuhiro
Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka 545-8585, Japan.
World J Hepatol. 2022 May 27;14(5):992-1005. doi: 10.4254/wjh.v14.i5.992.
Studies have shown that covered self-expandable metallic stents (CSEMS) with a low axial forces after placement can cause early recurrent biliary obstruction (RBO) due to precipitating sludge formation.
To ascertain whether the angle of CSEMS after placement is a risk factor for RBO in unresectable distal malignant biliary obstruction (MBO).
Between January 2010 and March 2019, 261 consecutive patients underwent self-expandable metallic stent insertion by endoscopic retrograde cholangiopancreatography at our facility, and 87 patients were included in this study. We evaluated the risk factors for RBO, including the angle of CSEMS after placement as the primary outcome. We measured the obtuse angle of CSEMS after placement on an abdominal radiograph using the SYNAPSE PACS system. We also evaluated technical and functional success, adverse events, time to RBO (TRBO), non-RBO rate, survival time, cause of RBO, and reintervention procedure as secondary outcomes.
We divided the patients into two cohorts based on the presence or absence of RBO. The angle of CSEMS after placement ( 1° and 10°) was evaluated using the multivariate Cox proportional hazard analysis, which was an independent risk factor for RBO in unresectable distal MBO [hazard ratio, 0.97 and 0.71; 95% confidence interval (CI): 0.94-0.99 and 0.54-0.92; = 0.01 and 0.01, respectively]. For early diagnosis of RBO, the cut-off value of the angle of CSEMS after placement using the receiver operating characteristic curve was 130° [sensitivity, 50.0%; specificity 85.5%; area under the curve 0.70 (95%CI: 0.57-0.84)]. TRBO in the < 130° angle group was significantly shorter than that in the ≥ 130° angle group ( < 0.01).
This study suggests that the angle of the CSEMS after placement for unresectable distal MBO is a risk factor for RBO. These novel results provide pertinent information for future stent management.
研究表明，放置后轴向力较低的覆膜自膨式金属支架（CSEMS）可因胆泥形成而导致早期复发性胆管梗阻（RBO）。
确定放置后CSEMS的角度是否是不可切除的远端恶性胆管梗阻（MBO）患者发生RBO的危险因素。
2010年1月至2019年3月期间，在我们机构有261例患者通过内镜逆行胰胆管造影术接受了自膨式金属支架置入，本研究纳入了87例患者。我们评估了RBO的危险因素，将放置后CSEMS的角度作为主要观察指标。我们使用SYNAPSE PACS系统在腹部X光片上测量放置后CSEMS的钝角。我们还评估了技术和功能成功率、不良事件、RBO发生时间（TRBO）、无RBO发生率、生存时间、RBO原因以及再次干预程序等次要观察指标。
根据是否发生RBO将患者分为两个队列。使用多变量Cox比例风险分析评估放置后CSEMS的角度（<1°和<10°），这是不可切除的远端MBO患者发生RBO的独立危险因素[风险比分别为0.97和0.71；95%置信区间（CI）：0.94 - 0.99和0.54 - 0.92；P值分别为0.01和0.01]。对于RBO的早期诊断，使用受试者工作特征曲线得出的放置后CSEMS角度的截断值为130°[灵敏度，50.0%；特异性85.5%；曲线下面积0.70（95%CI：0.57 - 0.84）]。<130°角度组的TRBO明显短于≥130°角度组（P<0.01）。
本研究表明，不可切除的远端MBO放置CSEMS后的角度是RBO的危险因素。这些新结果为未来的支架管理提供了相关信息。
