Chung Kwang Hyun, Lee Kyong Joo, Joseph Abel A, Huang Robert J, Li Andrew, Hwang Joo Ha, Yoon Seung Bae
Division of Gastroenterology, Department of Internal Medicine, Soonchunhyang University Hospital Seoul, Soonchunhyang University College of Medicine, Seoul, Republic of Korea; Division of Gastroenterology and Hepatology, Stanford University, Stanford, California, USA.
Division of Gastroenterology and Hepatology, Stanford University, Stanford, California, USA; Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Republic of Korea.
Gastrointest Endosc. 2025 Feb;101(2):350-357.e10. doi: 10.1016/j.gie.2024.09.037. Epub 2024 Sep 30.
Covered self-expandable metal stents (CSEMSs) are used for malignant hilar biliary obstruction (MHBO) management. Despite increasing evidence, a comprehensive evaluation of the efficacy and safety of CSEMSs in MHBO management is lacking.
PubMed, EMBASE, and the Cochrane Library were screened up to March 31, 2024, for studies including MHBO treated by a CSEMS. Studies meeting predefined inclusion criteria, including adult MHBO patients treated with CSEMS placement, reporting technical success, clinical success, and adverse event rates were selected. Data synthesis and statistical analysis were performed using the random-effects model, with heterogeneity and publication bias assessment.
From 401 articles, 7 studies were included. Pooled technical and clinical success rates of CSEMSs were 96.7% (95% confidence interval [CI], 92.6-98.6; I = 0%) and 91.6% (95% CI, 86.1-95.0; I = 0%). Overall adverse events were reported in 16.6% of cases (95% CI, 11.2-23.9; I = 24%), which included cholangitis (7.4%), pancreatitis (5.9%), liver abscess (5.9%), and cholecystitis (2.8%). Stent migration and recurrent biliary obstruction (RBO) were observed in 8.9% and 49.6% of cases, respectively, with a median time to RBO of 142 days. Reintervention was successful in 92.5% of cases (95% CI, 83.1-96.9; I = 0%).
Our meta-analysis revealed high technical and clinical success rates of CSEMS placement in MHBO. Adverse events, notably cholangitis, cholecystitis, and pancreatitis, were <10%. RBO and stent migration were mitigated by CSEMS removal and successful reintervention. Our findings highlight the efficacy and safety of CSEMSs in managing MHBO, warranting further research to optimize treatment strategies.
覆膜自膨式金属支架（CSEMSs）用于恶性肝门部胆管梗阻（MHBO）的治疗。尽管证据越来越多，但缺乏对CSEMSs在MHBO治疗中疗效和安全性的全面评估。
截至2024年3月31日，对PubMed、EMBASE和Cochrane图书馆进行筛选，以查找包括用CSEMS治疗MHBO的研究。选择符合预定义纳入标准的研究，包括接受CSEMS置入治疗的成年MHBO患者，报告技术成功率、临床成功率和不良事件发生率。使用随机效应模型进行数据合成和统计分析，并评估异质性和发表偏倚。
从401篇文章中，纳入了7项研究。CSEMSs的综合技术成功率和临床成功率分别为96.7%（95%置信区间[CI]，92.6 - 98.6；I² = 0%）和91.6%（95% CI，86.1 - 95.0；I² = 0%）。16.6%的病例报告了总体不良事件（95% CI, 11.2 - 23.9；I² = 24%），其中包括胆管炎（7.4%）、胰腺炎（5.9%）、肝脓肿（5.9%）和胆囊炎（2.8%）。分别在8.9%和49.6%的病例中观察到支架移位和复发性胆管梗阻（RBO），RBO的中位时间为142天。92.5%的病例再次干预成功（95% CI，83.1 - 96.9；I² = 0%）。
我们的荟萃分析显示，CSEMS置入治疗MHBO的技术成功率和临床成功率很高。不良事件，尤其是胆管炎、胆囊炎和胰腺炎，发生率<10%。通过取出CSEMS和成功的再次干预可减轻RBO和支架移位。我们的研究结果突出了CSEMSs在治疗MHBO中的疗效和安全性，值得进一步研究以优化治疗策略。
