Huapyong Kang1,2, Moon Jae Chung3, In Rae Cho4, Jung Hyun Jo3, Hee Seung Lee3, Jeong Youp Park3, Seung Woo Park3, Si Young Song3, Seungmin Bang5. 1. Division of Gastroenterology, Department of Internal Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea. 2. Department of Medicine, Yonsei University Graduate School, Seoul, Republic of Korea. 3. Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea. 4. Department of Internal Medicine, Liver Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea. 5. Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea. bang7028@yuhs.ac.
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.
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.
Entities:
Keywords:
Biliary stricture; Endobiliary; Malignant; Metal stent; Palliative; Radiofrequency ablation
Authors: Jana Nociarova; Marek Novak; Jan Polak; Jan Hrudka; Stefan Porubsky; Michal Koc; Jozef Rosina; Aleksandr N Grebenyuk; Radek Sery; Robert Gurlich; Jan Hajer Journal: J Healthc Eng Date: 2021-09-23 Impact factor: 2.682
Authors: Jana Jarosova; Peter Macinga; Lenka Krupickova; Martina Fialova; Alzbeta Hujova; Jan Mares; Ondrej Urban; Jan Hajer; Julius Spicak; Ilja Striz; Tomas Hucl Journal: Biomedicines Date: 2022-06-06
Authors: Maria A Gonzalez-Carmona; Christian Möhring; Robert Mahn; Taotao Zhou; Alexandra Bartels; Farsaneh Sadeghlar; Maximilian Bolch; Annabelle Vogt; Dominik J Kaczmarek; Dominik J Heling; Leona Dold; Jacob Nattermann; Vittorio Branchi; Hanno Matthaei; Steffen Manekeller; Jörg C Kalff; Christian P Strassburg; Raphael U Mohr; Tobias J Weismüller Journal: Sci Rep Date: 2022-01-19 Impact factor: 4.379