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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
 Huapyong Kang  ;  Moon Jae Chung  ;  In Rae Cho  ;  Jung Hyun Jo  ;  Hee Seung Lee  ;  Jeong Youp Park  ;  Seung Woo Park  ;  Si Young Song  ;  Seungmin Bang 
Citation
 SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES, Vol.35(1) : 63-73, 2021-01 
Journal Title
SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES
ISSN
 0930-2794 
Issue Date
2021-01
Keywords
Biliary stricture ; Endobiliary ; Malignant ; Metal stent ; Palliative ; Radiofrequency ablation
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.
Full Text
https://link.springer.com/article/10.1007/s00464-020-07689-z
DOI
10.1007/s00464-020-07689-z
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Park, Seung Woo(박승우) ORCID logo https://orcid.org/0000-0001-8230-964X
Park, Jeong Youp(박정엽) ORCID logo https://orcid.org/0000-0003-0110-8606
Bang, Seungmin(방승민) ORCID logo https://orcid.org/0000-0001-5209-8351
Song, Si Young(송시영) ORCID logo https://orcid.org/0000-0002-1417-4314
Lee, Hee Seung(이희승) ORCID logo https://orcid.org/0000-0002-2825-3160
Chung, Moon Jae(정문재) ORCID logo https://orcid.org/0000-0002-5920-8549
Jo, Jung Hyun(조중현) ORCID logo https://orcid.org/0000-0002-2641-8873
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/181963
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