Yun Nah Lee1, Seok Jeong2, Hyun Jong Choi1, Jae Hee Cho3, Young Koog Cheon4, Se Woo Park5, Yeon Suk Kim3, Don Haeng Lee2, Jong Ho Moon1. 1. Digestive Disease Center and Research Institute, Department of Internal Medicine, Soonchunhyang University School of Medicine, Korea. 2. Digestive Disease Center, Department of Internal Medicine, Inha University School of Medicine, Korea. 3. Department of Internal Medicine, Gil Medical Center, Gachon University, Korea. 4. Digestive Disease Center, Department of Internal Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Korea. 5. Department of Internal Medicine, Institute of Gastroenterology, Hallym University College of Medicine, Hallym University Dongtan Sacred Heart Hospital, Korea.
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.
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.