Endoluminal biliary radiofrequency ablation (RFA) has been proposed as a palliative treatment for patients with malignant biliary obstruction (MBO) in order to improve stent patency and survival. However, the existing data on patients with inoperable extrahepatic cholangiocarcinoma (eCCA) are conflicting. We performed a meta-analysis of randomized trials comparing RFA plus stenting versus stenting alone in patients with inoperable eCCA. We searched for trials published in the PubMed/MEDLINE, Scopus, and Cochrane databases up to November 2023. Data extraction was conducted from published studies, and a quality assessment was carried out in accordance with the guidelines recommended by the Cochrane Collaboration. Hazard ratios (HRs) with 95% CI were estimated from the trials. The primary endpoints of interest were overall survival and stent patency. Out of 275 results, 5 randomized trials and 370 patients were included. While overall survival was not different between the groups (HR 0.62; 95% CI 0.36–1.07;p= 0.09; I2= 80%;), the subgroup analysis of studies employing plastic stents showed a trend toward better survival in the RFA-treated group (HR 0.42; 95% CI 0.22–0.80;p= 0.009; I2= 72%). Stent patency was improved in patients receiving RFA (HR 0.64; 95% CI 0.45–0.90;p= 0.01; I2= 23%). Adverse events were not different between the groups (OR 1.21; 95% CI 0.69–2.12;p= 0.50; I2= 0%). Despite the promising results, high heterogeneity and potential biases in the included studies suggest the need for further high-quality randomized trials to explore the potential cumulative effects of RFA on CCA treatment outcomes.
腔内胆道射频消融术已被提议作为恶性胆道梗阻患者的姑息治疗手段,旨在改善支架通畅率并延长生存期。然而,现有关于不可切除肝外胆管癌患者的数据存在矛盾。我们对比较射频消融联合支架置入与单纯支架置入治疗不可切除肝外胆管癌的随机试验进行了荟萃分析。我们检索了截至2023年11月发表于PubMed/MEDLINE、Scopus和Cochrane数据库的相关试验。数据提取自已发表的研究,并依据Cochrane协作网推荐指南进行质量评估。从试验中估算风险比及其95%置信区间。主要观察终点为总生存期和支架通畅率。在275项检索结果中,共纳入5项随机试验涉及370例患者。虽然两组间总生存期无显著差异(HR 0.62;95% CI 0.36–1.07;p=0.09;I²=80%),但使用塑料支架研究的亚组分析显示射频消融治疗组存在生存获益趋势(HR 0.42;95% CI 0.22–0.80;p=0.009;I²=72%)。接受射频消融治疗患者的支架通畅率显著改善(HR 0.64;95% CI 0.45–0.90;p=0.01;I²=23%)。两组间不良事件发生率无统计学差异(OR 1.21;95% CI 0.69–2.12;p=0.50;I²=0%)。尽管结果令人鼓舞,但纳入研究存在高度异质性和潜在偏倚,提示需要进一步开展高质量随机试验以探索射频消融对胆管癌治疗结局的潜在累积效应。