Safety and effectiveness of endobiliary radiofrequency ablation according to the different power and target temperature in a swine model

Abstract

EB-RFA using a temperature controlled RFA catheter successfully ablates the bile duct wall without adverse events in a swine model.

The safety of newly developed automatic temperature‐controlled endobiliary radiofrequency ablation system for malignant biliary strictures: A prospective multicenter study

“…RFA therapy has already been used to treat patients with hepatocellular carcinoma or Barrett's esophagus with dysplasia. The local, ablative therapeutic effects of RFA are achieved by the heat generated at the RF catheter's bipolar electrodes, which results in local coagulation necrosis and adjacent inflammatory reactions at the contact area . However, definitive data from well‐controlled, prospective studies on the efficacy of endobiliary RFA are lacking.…”

“…The temperature at the electrodes located at the catheter tip is automatically monitored and an automatic on and off function maintains the preset temperature . The thermal effects of the new RF catheter and the degree of coagulation injury were evaluated in an animal study . The median depth of maximal ablation was 2.7 mm (range, 2.5–4.3) at a setting of 10 W with the 33‐mm catheter for 120 s and 2.1 mm (range, 1.7–2.4) at a setting of 7 W with the 18‐mm catheter.…”

“…The local, ablative therapeutic effects of RFA are achieved by the heat generated at the RF catheter's bipolar electrodes, which results in local coagulation necrosis and adjacent inflammatory reactions at the contact area. 3,11,16 However, definitive data from well-controlled, prospective studies on the efficacy of endobiliary RFA are lacking. Sofi et al 15 published a systematic review and meta-analysis of RFA combined with biliary stenting versus stenting alone for MBS.…”

“…It is equipped with a temperature sensor in the bipolar electrodes and is connected to an RF generator. The power is automatically stopped whenever the temperature of the electrodes reaches the preset target temperature, so that unintended overheating is avoided . In previous studies of this RF catheter in a normal swine model, heat energy values that would allow clinical application were determined and the early and long‐term effects on the swine bile duct were evaluated .…”

“…11 In previous studies of this RF catheter in a normal swine model, heat energy values that would allow clinical application were determined and the early and long-term effects on the swine bile duct were evaluated. 11,12 The present study is a preliminary analysis before a prospective randomized controlled trial to evaluate the efficacy of this RF catheter. Our aim was to confirm the clinical safety of temperature-controlled endobiliary RFA using the newly developed catheter for the treatment of extrahepatic MBS.…”