Efficacy and safety of palliative endobiliary radiofrequency ablation using a novel temperature-controlled catheter for malignant biliary stricture: a single-center prospective randomized phase II TRIAL
- Authors
- Kang H.; Chung M.J.; Cho I.R.; Jo J.H.; Lee H.S.; Park J.Y.; Park S.W.; Song S.Y.; Bang S.
- Issue Date
- Jan-2021
- Publisher
- SPRINGER
- Keywords
- Biliary stricture; Endobiliary; Malignant; Metal stent; Palliative; Radiofrequency ablation
- Citation
- SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES, v.35, no.1, pp.63 - 73
- Journal Title
- SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES
- Volume
- 35
- Number
- 1
- Start Page
- 63
- End Page
- 73
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/79664
- DOI
- 10.1007/s00464-020-07689-z
- ISSN
- 0930-2794
- Abstract
- Background: Endobiliary radiofrequency ablation (EB-RFA) has emerged as a palliative treatment for malignant biliary strictures (MBSs); however, concerns about complications related to thermal injury remain. In this study, we evaluated the efficacy and safety of EB-RFA with a novel catheter for MBS. Methods: Patients with inoperable cancer causing MBS were randomly assigned to either the radiofrequency ablation (RFA) group or the non-RFA group. The RFA group underwent EB-RFA at the stricture site with a temperature-controlled catheter (ELRA™; STARmed Co., Goyang, Korea) followed by deployment of a self-expanding metal stent (SEMS). For the non-RFA group, only SEMS placement was performed. The duration of stent patency, overall survival (OS), and 30-day complication rate were evaluated. This trial was registered at ClinicalTrials.gov (number NCT02646514). Results: A total of 48 patients were enrolled (24 in each group). During a median follow-up period of 135.0 days (RFA group) and 119.5 days (non-RFA group), the 90-day stent patency rate, median duration of stent patency, and median OS were not different between the groups (58.3% vs. 45.8% [P = 0.386], 132.0 days vs. 116.0 days [P = 0.440], and 244.0 days vs. 180.0 days [P = 0.281], respectively). In the RFA group, procedure-related complications including thermal injury-related complications, such as bile duct perforation or hemobilia, were not reported. The early complication (< 7 days) rates were not different between the groups (4.2% vs. 12.5%, P = 0.609), and there were no late complications (7–30 days) in both groups. Conclusion: EB-RFA with a temperature-controlled catheter followed by SEMS placement for patients with inoperable MBS can be safe and feasible with acceptable biliary patency. © 2020, Springer Science+Business Media, LLC, part of Springer Nature.
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