Background and study aims: Recurrent biliary stent occlusion and tumor ingrowth remain a major concern among patients with malignant biliary obstruction (MBO) with significant impact on patient morbidity and survival. Intraductal radiofrequency ablation (RFA) has emerged as a promising treatment that seeks to extend stent patency. This study aimed to evaluate the impact of RFA on overall survival (OS) and stent patency among patients with unresectable MBO.
Methods: A comprehensive search of electronic databases was performed for randomized controlled trials (RCTs) comparing RFA plus biliary stent (RFA+S) versus biliary stent alone (S-alone). Outcomes assessed included overall survival, stent patency, and adverse events (AEs) with mean difference (MD) calculated from pooled proportions. Subgroup analyses were performed for hilar strictures and cholangiocarcinoma (CCA).
Results: Six RCTs (n = 439 patients) were included and demonstrated improved survival among patients who received RFA+S (MD 85.80 days; 95% confidence interval [CI] 35.02-136.58; I2 = 97%; P < 0.0009). The pooled MD for total stent patency was 22.25 days (95% CI 17.38- 61.87; I<sup>2</sup> = 97%; <i>P</i> = 0.27). There was no difference in AEs between RFA+S vs S-alone (<i>P</i> > 0.05). On subgroup analyses, RFA+S was associated with improved stent patency (MD 76.73 days; 95% CI 50.11-103.34; I<sup>2</sup> = 67%; <i>P</i> <0.01) and OS (MD 83.14 (95% CI 29.52-136.77; I<sup>2</sup> = 97%; <i>P</i> < 0.01] for CCA. For hilar strictures, stent patency was improved among patients with RFA+S [MD 83.71 days (95% CI 24.85-142.56; I<sup>2</sup> = 84%; <i>P</i> < 0.01].
<b>Conclusions:</b> RFA+S improved OS in the treatment of MBO when compared with S-alone. Moreover, the RFA therapy prolonged stent patency in hilar strictures and CCA, with similar rates of AEs.