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评估塑料支架与金属支架在恶性肝门部胆管梗阻中的安全性和有效性:一项随机对照试验的系统评价和荟萃分析

Evaluating safety and efficacy of plastic versus metal stenting in malignant hilar biliary obstruction: a systematic review and meta-analysis of randomized controlled trials.

作者信息

Luo Xinjie, Huang Zhicheng, Ali Kamran, Hayat Khizar

机构信息

Department of surgery, Hangzhou First People's Hospital Tonglu Campus, 311500, Hangzhou, China.

Department of Intensive Care Unit, Hangzhou Geriatric Hospital, 50 Jingshen Road, 310022, Hangzhou, China.

出版信息

Postgrad Med J. 2025 Apr 22;101(1195):447-457. doi: 10.1093/postmj/qgae165.

DOI:10.1093/postmj/qgae165
PMID:39571584
Abstract

BACKGROUND

Stenting malignant hilar biliary obstruction (MHBO) is challenging due to its complex structure, and it is less effective than blockages in the distal bile duct area. Plastic stents (PSs) and metal stents (MSs) are commonly used for stenting MHBO. This study aims to compare the outcomes of PSs and MSs in MHBO patients.

METHODS

We conducted a search of medical databases up to March 2024. Using a fixed-effect model, we analyzed the risk ratios (RRs) of the outcomes between the PS and MS groups. We calculated the RR for clinical and technical success, reinterventions, and adverse events, as well as the hazard ratio (HR) for survival and stent patency.

RESULTS

This analysis includes five randomized controlled trials (RCTs) that met the inclusion criteria, comprising a total of 322 patients (156 in the PS group and 166 in the MS group). Significant differences (P < .05) in favor of the MS group were found in the reinterventions (RR 1.80, 95% CI 1.07-3.04), and stent patency (HR 0.54, 95% CI 0.32-0.90). There were no significant differences (P > 0.05) between the PS and MS groups regarding technical success (RR 1.01, 95% CI 0.94-1.09), clinical success (RR 0.86, 95% CI 0.69-1.07), overall survival (HR 0.71, 95% CI 0.47-1.05), stent migration (RR 0.69, 95% CI 0.08-6.02), stent occlusion (RR1.32, 95% CI 0.97-1.81), and adverse events (RR 0.80, 95% CI 0.53-1.20).

CONCLUSION

Both PS and MS are effective for managing MHBO, while MS offers greater efficacy in increased stent patency and lower reintervention rates. Key message What is already known on this topic Metal stents (MSs) and plastic stents (PSs) are used for palliative treatment of malignant hilar biliary obstruction (MHBO). MSs significantly reduced the need for reinterventions compared to PSs in patients with MHBO. What this study adds There were no significant differences between MSs and PSs in terms of technical success, clinical success, overall survival, stent migration, stent occlusion, or adverse events. How this study might affect research, practice, or policy The study's findings may prompt researchers to design more targeted studies to further investigate these specific outcomes in MHBO patients. The results encourage endoscopists to consider patient-specific factors, such as life expectancy and preference for minimizing recurrent procedures, when choosing between MSs and PSs for MHBO.

摘要

背景

恶性肝门部胆管梗阻(MHBO)的支架置入术具有挑战性,因为其结构复杂,且其效果低于胆管远端区域的梗阻。塑料支架(PSs)和金属支架(MSs)常用于MHBO的支架置入。本研究旨在比较PSs和MSs在MHBO患者中的治疗效果。

方法

我们检索了截至2024年3月的医学数据库。使用固定效应模型,我们分析了PS组和MS组之间治疗效果的风险比(RRs)。我们计算了临床和技术成功率、再次干预和不良事件的RR,以及生存和支架通畅的风险比(HR)。

结果

该分析纳入了5项符合纳入标准的随机对照试验(RCTs),共322例患者(PS组156例,MS组166例)。在再次干预(RR 1.80,95%CI 1.07-3.04)和支架通畅率(HR 0.54,95%CI 0.32-0.90)方面,发现MS组有显著差异(P< 0.05)。在技术成功率(RR 1.01,95%CI 0.94-1.09)、临床成功率(RR 0.86,95%CI 0.69-1.07)、总生存期(HR 0.71,95%CI 0.47-1.05)、支架移位(RR 0.69,95%CI 0.08-6.02)、支架闭塞(RR1.32,95%CI 0.97-1.81)和不良事件(RR 0.80,95%CI 0.53-1.20)方面,PS组和MS组之间无显著差异(P> 0.05)。

结论

PSs和MSs在治疗MHBO方面均有效,而MSs在提高支架通畅率和降低再次干预率方面疗效更佳。关键信息关于该主题的已知信息金属支架(MSs)和塑料支架(PSs)用于恶性肝门部胆管梗阻(MHBO)的姑息治疗。在MHBO患者中,与PSs相比,MSs显著减少了再次干预的需求。本研究的补充内容在技术成功率、临床成功率、总生存期、支架移位、支架闭塞或不良事件方面,MSs和PSs之间无显著差异。本研究可能对研究、实践或政策产生的影响该研究结果可能促使研究人员设计更具针对性的研究,以进一步调查MHBO患者的这些特定治疗效果。结果鼓励内镜医师在为MHBO患者选择MSs和PSs时,考虑患者的特定因素,如预期寿命和对减少复发程序的偏好。

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