The combination of endoluminal radiofrequency ablation and metal stent implantation for the treatment of malignant biliary stenosis-Randomized study

Purpose: To analyse whether endobiliary radiofrequency ablation prior metal stent insertion in malignant biliary stenosis show improved survival or stent patency. Methods: 76 patients with histologically proven malignant biliary stenosis have been enrolled in a prospective, randomized study. In control arm, 40 patients underwent self-expandable metal stent insertion. In experimental arm, the endoluminal ablation with a bipolar radiofrequency catheter was performed immediately before stent insertion. A subgroup analysis of cholangiocarcinoma was performed (22 vs 21 patients). The objective of the study was to determine the rate of complications, duration of the stent patency and the survival of patients (Kaplan-Meier analysis). Results: No major complications related to the stent insertion and the endoluminal ablation were found. The mean primary stent patency was 5.2 (95% CI 0.7-12.8) vs 4.8 months (95% CI 0.8-18.2) months (p = 0.79) in control and experimental group, respectively, in the subgroup analysis with cholangiocarcinoma 4.5 (95% CI 0.8-10.3) and 9.6 (95% CI 5.2-11.2) months (p = 0.029). The median survival since the insertion of the stent was 6.8 (95 %CI 3.0-10.6) vs 5.2 (95 %CI 2.4-7.9) months (p = 0.495) and since the initial drainage 9.8 (95 %CI 6.9-12.7) vs 9.1 (95 %CI 5.4-12.7) months (p = 0.720) in the control and experimental arm. Conclusion: Endobiliary radiofrequency ablation prior metal stent insertion showed increased patency rate only in patients with cholangiocarcinoma, on the other hand, no improvement in survival was demonstrated in this randomized clinical study.