Endoscopically applied radiofrequency ablation appears to be safe in the treatment of malignant biliary obstruction.

BACKGROUND In unresectable malignant bile duct obstruction in a patient with a life expectancy longer than 3 months, the use of self-expandable metal stents (SEMSs) is the standard technique to ensure continued biliary drainage. As many as 50% of patients with SEMSs will present with stent occlusion within 6 months. Changes to stent design and composition and concomitant therapy have failed to improve stent patency; therefore, alternative techniques to safely prolong stent patency are required. OBJECTIVE To demonstrate the safety of endobiliary bipolar radiofrequency ablation (RFA) in patients with malignant biliary obstruction and to report the 90-day biliary patency of this novel procedure. DESIGN Open-label pilot study. SETTING Single tertiary care unit. PATIENTS A total of 22 patients with unresectable malignant bile duct obstruction. INTERVENTIONS Bipolar RFA within the bile duct. MAIN OUTCOME MEASUREMENTS Immediate and 30-day complications and 90-day stent patency. RESULTS A total of 22 patients (16 pancreatic, 6 cholangiocarcinoma) were recruited between January 2009 and April 2010. Deployment of an RFA catheter was successful in 21 patients. SEMS placement was achieved in all cases of successful RFA catheter deployment. One patient failed to demonstrate successful biliary decompression after SEMS placement and died within 90 days. All other patients maintained stent patency at 30 days. One patient had asymptomatic biochemical pancreatitis, 2 patients required percutaneous gallbladder drainage, and 1 patient developed rigors. At 90-day follow-up, 1 additional patient had died with a patent stent, and 3 patients had occluded biliary stents. LIMITATIONS Cohort study. CONCLUSIONS Endobiliary RFA treatment appears to be safe. Randomized studies with prolonged follow-up are warranted.