内腔射频消融术（RFA）被推广为胆管癌（CCA）和胰腺导管腺癌（PDAC）患者的姑息治疗方法，以改善胆汁引流并最终延长生存期。然而，目前没有关于该技术的高水平证据。在这项随机对照研究中，我们比较了内腔RFA联合支架与单独支架（对照组）在恶性胆道梗阻患者中的应用；首选金属支架。主要观察指标是总生存期，次要观察指标包括支架通畅性、生活质量和不良事件。在优势设计中，假定RFA的生存期为对照组（n=280）的两倍，即6.4个月。在中位年龄为71±9岁的161名受试者中进行随机分组，招募结束后进行了无效中期分析。85名患者患有CCA（73例肝门型，12例远端型），76例患有胰腺癌。在两个亚组中均未观察到存活差异：对于CCA患者，RFA组的中位生存期为10.5个月（95% 可信区间6.7至18.3），对照组为10.6个月（95% 可信区间9.0至24.8），p=0.58）。在胰腺癌亚组中，RFA组的中位生存期为6.4个月（95% 可信区间4.3至9.7），对照组为7.7个月（95% 可信区间5.6至11.3），p=0.73）。在RFA组中未观察到支架通畅性的好处（CCA组12个月时为40%，对照组为36%；PDAC组为66%和65%）。两种治疗对生活质量均没有改变，并且在两个组之间是可比较的。两组患者均出现了七例不良事件。内腔RFA和支架联合应用在延长恶性胆道梗阻患者的生存期或改善支架通畅性方面并不优于单独支架。NCT03166436.© 作者（或其雇主）2023。未经商业再利用。请参阅权利和许可。由BMJ发表。

Endoluminal radiofrequency ablation (RFA) has been promoted as palliative treatment for patients with cholangiocarcinoma (CCA) and pancreatic ductal adenocarcinoma (PDAC) in order to improve biliary drainage and eventually prolong survival. No high level evidence is, however, available on this technique.In this randomised controlled study, we compared endoluminal RFA plus stenting with stenting alone (control group) in patients with malignant biliary obstruction; metal stents were primarily placed. Primary outcome was overall survival; secondary outcomes were stent patency, quality of life and adverse events. In a superiority design, survival was assumed to be doubled by RFA as compared with 6.4 months in the control group (n=280).A total of 161 patients (male:female 90:71, mean age 71±9 years) were randomised before recruitment was terminated for futility after an interim analysis. Eighty-five patients had CCA (73 hilar, 12 distal) and 76 had pancreatic cancer. There was no difference in survival in both subgroups: for patients with CCA, median survival was 10.5 months (95% CI 6.7 to 18.3) in the RFA group vs 10.6 months (95% CI 9.0 to 24.8), p=0.58)) in the control group. In the subgroup with pancreatic cancer, median survival was 6.4 months (95% CI 4.3 to 9.7) for the RFA vs 7.7 months (95% CI 5.6 to 11.3), p=0.73) for the control group. No benefit was seen in the RFA group with regard to stent patency (at 12 months 40% vs 36% in CCA and 66% vs 65% in PDAC), and quality of life was unchanged by either treatment and comparable between the groups. Adverse events occurred in seven patients in each groups.A combination of endoluminal RFA and stenting was not superior to stenting alone in prolonging survival or improving stent patency in patients with malignant biliary obstruction.NCT03166436.© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.