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

Abstract

Background and Aims Catheter‐based endobiliary radiofrequency ablation (RFA) is an endoscopic local treatment for patients with malignant biliary stricture (MBS). However, excessive heating of the bile duct by the current RFA system can induce serious complications. Recently, a new RFA system with automatic temperature control was developed. In the present study, we examined the safety of the new RFA system in patients undergoing endobiliary RFA for extrahepatic MBS. Methods This prospective, multicenter study enrolled patients with unresectable or inoperable extrahepatic (> 2 cm from the hilum) MBS. Endobiliary RFA was performed using a newly developed RFA catheter (ELRA™, STARmed, Goyang, Korea) at a setting of 7 or 10 W for 120 s and with a target temperature of 80°C. A self‐expandable metallic stent was inserted after endobiliary RFA. The rate of procedure‐related adverse events was assessed. Results The 30 patients were enrolled in this study. Cholangiocarcinoma was diagnosed in 19 patients, pancreatic cancer was found in 9, and gallbladder cancers were recorded in 2. The mean stricture length was 22.1 ± 6.6 mm. Post‐procedural adverse events occurred in three patients (10.0%; 2 mild pancreatitis and 1 cholangitis) without hemobilia and bile duct perforation. The pancreatitis and cholangitis resolved with conservative treatment. The cumulative duration of stent patency and survival were 236 and 383 days, respectively. Conclusions Automatic temperature‐controlled endobiliary RFA using a newly developed catheter was safely applied in patents with extrahepatic MBS. Further prospective studies are needed to confirm the efficacy of endobiliary RFA for MBS.

Novel balloon catheter‐based endobiliary radiofrequency ablation system: Ex‐vivo experimental study

“…Recently, an RFA catheter with a shorter distance between the electrodes and equipped with a temperature sensor has been developed to mitigate these limitations. 8,9 We tested a balloon-based RFA, which is a different approach. One of the advantages of the balloon catheter is that it can be trimmed down, so it can be inserted into the working channel of the cholangioscope.…”

Current Endoscopic Management of Malignant Biliary Stricture

“…Endoscopic drainage has a low risk of complications, but it is associated with a high probability of recurrent biliary obstruction [32] when compared with surgical bypass. After an endobiliary radiofrequency ablation (RFA) system was applied to biliary malignant obstructions, series intra-luminal RFA and self-expanding metal stents (SEMS) became a safe treatment choice with better intervention-free survival compared to SEMS alone [33][34][35]. Percutaneous trans-hepatic cholangiography and drainage (PTCD) should be reserved for unsuccessful endoscopic procedures in patients with MDBO.…”

Recent Update of Endoscopic Radiofrequency Ablation for Pancreatobiliary Disease

“…1 , , , . [6][7][8][9][10][11][12][13][14][15][16][17] RFA cardiac pacemaker, , Mild post-procedural fever 5…”