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The safety of newly developed automatic temperature‐controlled endobiliary radiofrequency ablation system for malignant biliary strictures: A prospective multicenter study
Author(s) -
Lee Yun Nah,
Jeong Seok,
Choi Hyun Jong,
Cho Jae Hee,
Cheon Young Koog,
Park Se Woo,
Kim Yeon Suk,
Lee Don Haeng,
Moon Jong Ho
Publication year - 2019
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1111/jgh.14657
Subject(s) - medicine , radiofrequency ablation , pancreatitis , catheter , prospective cohort study , bile duct , perforation , stent , catheter ablation , gallbladder , adverse effect , radiology , surgery , hilum (anatomy) , ablation , gastroenterology , materials science , metallurgy , punching
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.