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胆管支架置入联合腔内¹²⁵I粒子近距离治疗与单纯胆管支架置入治疗胆管癌的Meta分析

Biliary Stenting Combined With Intraluminal 125I Seed Brachytherapy Versus Biliary Stenting Alone for the Treatment of Cholangiocarcinoma: a Meta-analysis.

作者信息

Chen Mei-Ling, Wang Xiu-Lin, Yu Hang, Salameen Haitham, Ding Xiong, Wang Yun-Bing

机构信息

Department of Hepatobiliary Surgery, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.

The Second Clinical College, Chongqing Medical University, Chongqing, China.

出版信息

Int J Surg. 2025 Jul 17. doi: 10.1097/JS9.0000000000002984.

Abstract

BACKGROUND

Patients with advanced cholangiocarcinoma (CCA) often experience malignant obstructive jaundice (MOJ), which significantly impacts both their quality of life and prognosis. Recent studies suggest that the addition of iodine-125 (125I) radioactive seeds during stent placement may improve stent patency and extend patient survival. However, the conclusions drawn from different studies remain inconsistent, and there is a lack of a systematic assessment to better clarify the clinical benefits of this treatment.

OBJECTIVE

To compare and evaluate the efficacy and safety of biliary stenting combined with intraluminal 125I seed brachytherapy versus biliary stenting alone in patients with advanced CCA and MOJ.

METHODS

A systematic search of databases (PubMed, Embase, Cochrane, Web of Science, Wanfang Data, CQVIP, China National Knowledge Infrastructure [CNKI], and Chinese Biomedical [CBM]) was conducted to identify studies published before June 2025 that compared stents with or without 125I seeds in the treatment of advanced CCA. The quality of the included studies was assessed using the Cochrane Collaboration's tool and the Newcastle-Ottawa Scale (NOS). The outcomes measured include overall survival, local control rate, tumor shrinkage, stent patency, stent obstruction, liver function, and complications.

RESULTS

Fourteen studies, including six randomized controlled trials and eight retrospective cohort studies, with a total of 1,078 patients, were included in this meta-analysis. Of these, 564 patients were treated with biliary stenting combined with intraluminal 125I seed brachytherapy (group A), while 514 patients received conventional biliary stenting alone (group B). The pooled analysis revealed that group A had a significantly longer overall survival (P < 0.001) and stent patency (P < 0.001) compared to group B. No significant differences were observed between the two groups in the overall incidence of complications (P = 0.854), acute cholangitis (P = 0.464), biliary infection (P = 0.903) and hemobilia (P = 0.364). Additionally, no significant differences were found in post-treatment reductions of serum indices such as total bilirubin (P = 0.134), direct bilirubin (P = 0.946), alanine aminotransferase (P = 0.096) and aspartate aminotransferase (P = 0.304). Subgroup analyses based on the type of 125I seed stent and study design demonstrated consistent results across the different categories.

CONCLUSION

Biliary stenting combined with intraluminal 125I seed brachytherapy improves overall survival and extends stent patency compared to conventional biliary stenting, without increasing complications and causing severe liver damage. Therefore, it can be considered an effective and safe treatment for advanced CCA and MOJ.

摘要

背景

晚期胆管癌(CCA)患者常出现恶性梗阻性黄疸(MOJ),这对其生活质量和预后均有显著影响。近期研究表明,在放置支架过程中添加碘-125(125I)放射性粒子可能会提高支架通畅率并延长患者生存期。然而,不同研究得出的结论仍不一致,且缺乏系统评估以更好地阐明这种治疗方法的临床益处。

目的

比较和评估胆管支架置入联合腔内125I粒子近距离放疗与单纯胆管支架置入术治疗晚期CCA合并MOJ患者的疗效和安全性。

方法

系统检索数据库(PubMed、Embase、Cochrane、Web of Science、万方数据、维普资讯、中国知网[CNKI]和中国生物医学文献数据库[CBM]),以确定2025年6月之前发表的比较在治疗晚期CCA时使用或不使用125I粒子的支架的研究。使用Cochrane协作工具和纽卡斯尔-渥太华量表(NOS)评估纳入研究的质量。测量的结果包括总生存期、局部控制率、肿瘤缩小、支架通畅率、支架阻塞、肝功能和并发症。

结果

本荟萃分析纳入了14项研究,包括6项随机对照试验和8项回顾性队列研究,共1078例患者。其中,564例患者接受胆管支架置入联合腔内125I粒子近距离放疗(A组),而514例患者仅接受传统胆管支架置入术(B组)。汇总分析显示,与B组相比,A组的总生存期(P<0.001)和支架通畅率显著更长(P<0.001)。两组在并发症总发生率(P=0.854)、急性胆管炎(P=0.464)、胆系感染(P=0.903)和胆道出血(P=0.364)方面未观察到显著差异。此外,在治疗后血清指标如总胆红素(P=0.134)、直接胆红素(P=0.946)、谷丙转氨酶(P=0.096)和谷草转氨酶(P=0.304)的降低方面也未发现显著差异。基于125I粒子支架类型和研究设计的亚组分析在不同类别中显示出一致的结果。

结论

与传统胆管支架置入术相比,胆管支架置入联合腔内125I粒子近距离放疗可提高总生存期并延长支架通畅率,且不增加并发症和导致严重肝损伤。因此,可将其视为治疗晚期CCA合并MOJ的一种有效且安全的治疗方法。

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