Authors W. LALEMAN (1), S. VAN DER MERWE (1), L. VERBEKE (1), H. VAN MALENSTEIN (1), R. AERTS (2), H. PRENEN (1), E. VAN CUTSEM (1), C. VERSLYPE (1) / [1] University Hospitals KULeuven, Leuven, Belgium, Gastroenterology & Hepatology, [2] University Hospitals KULeuven, Leuven, Belgium, Abdominal Surgery Introduction Biliary stenting of unresectable malignant bile duct obstruction is generally accepted as the standard of care but is hampered by tumor ingrowth and stent dysfunction. Aim We aimed to test feasibility, efficacy and safety of a new endoscopically applied dedicated intraductal radiofrequency ablation (RFA) device and compare these findings to a historical matched control group Methods This project was designed as a prospective open-label phase 2 single center study aiming to include 18 patients with inoperable malignant biliary obstruction (9 proximal and 9 distal lesions). All were scheduled for biliary drainage with stenting via ERCP combined with intraductal RFA and compared to 18 matched historical control patients with stenting but without RFA. Main outcome measurements involved technical feasibility, adverse events within first 90 days, duration of stent patency and overall survival. Results Between December 2014 and November 2015, 18 patients were recruited and all underwent RFA to the intended region and without complications within 3 months post-procedure. Bilirubin levels post-RFA and stenting decreased significantly but did not differ to stenting alone. The average stent patency however proved to be longer after RFA (P<0.001) with less stent dysfunction in the RFA group (P=0.08). RFA-application delivered a survival benefit in comparison to the control group (P=0.0078) with the best outcome for the subgroup treated with RFA combined with chemotherapy. Conclusions Intraductal RFA using a new device in patients with inoperable biliopancreatic complicated with jaundice appeared 100% feasible and safe. RFA resulted in a higher degree and longer maintenance of stent patency compared to a historical matched control group with only stenting. Moreover, a survival benefit was suggested when RFA was combined with palliative chemotherapy
