Efficacy and safety of a self‐expandable stent‐based endobiliary radiofrequency ablation: A preclinical study
6 affiliations
- 1Biomedical Engineering Research Center, Asan Institute for Life Sciences Asan Medical Center Seoul Republic of Korea
- 2Department of Convergence Medicine Asan Medical Center, University of Ulsan College of Medicine Seoul Republic of Korea
- 3Department of Biomedical Engineering, School of ICT Convergence Engineering, College of Science & Technology Konkuk University Chungju‐si Chungcheongbuk‐do Republic of Korea
- 4Department of Mechatronics Engineering, School of ICT Convergence Engineering, College of Science & Technology Konkuk University Chungju‐si Chungcheongbuk‐do Republic of Korea
- 5OSY Med Inc. Yongin Republic of Korea
- 6Department of Gastroenterology Asan Medical Center, University of Ulsan College of Medicine Seoul Republic of Korea
Abstract
The temperature‐controlled, bipolar self‐expandable stent (SES)‐based radiofrequency ablation (RFA) system represents a novel endobiliary RFA approach; however, its efficacy and safety must be verified before clinical application. The study aimed to investigate the efficacy and safety of SES–RFA in a porcine common bile duct (CBD) model. Ablation ranges were investigated using ex vivo porcine liver according to radiofrequency energy and time. For the in vivo study, radiofrequency parameters were set at 20 W for a 20‐mm electrode and 25 W for a 25‐mm electrode at 70°C for 120 s. Twelve pigs underwent endoscopic‐guided SES–RFA using either electrode (n = 6 each). Animals were randomly euthanized at 24 h or 2 weeks after SES–RFA (n = 3 per group). The RFA‐treated CBDs were evaluated using cholangiography, cholangioscopy, hematology, histology, and immunohistochemistry. The SES–RFA system was successfully deployed and retrieved through‐the‐scope without device failure. All animals survived until the study endpoint without RFA‐related adverse events, including ductal perforation, contrast leakage, or hematoma. Hepatobiliary levels of alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, and gamma‐glutamyl transferase were significantly higher at 2 weeks than at 24 h post‐SES–RFA (all p< 0.05). Ablation ranges and degree of mucosal damage, including collagen and TUNEL‐positive deposition, were significantly increased at 2 weeks than at 24 h (all p< 0.05). The temperature‐controlled bipolar SES–RFA system effectively and safely produced circumferential coagulative necrosis without ductal perforation in the porcine CBD. The system may be used for managing unresectable malignant biliary obstruction in anatomically challenging regions where conventional RFA is difficult to use.
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BibTeX
@article{won2026efficacy,
title = {{Efficacy and safety of a self‐expandable stent‐based endobiliary radiofrequency ablation: A preclinical study}},
author = {Dong‐Sung Won and Yubeen Park and Ji Won Kim and Jinsu An and Hyung‐Sik Kim and Se‐Chul Lee and Youngjae Lee and Dongwook Oh and Jung‐Hoon Park},
journal = {Bioengineering \& Translational Medicine},
year = {2026},
month = nov,
doi = {10.1002/btm2.70195},
url = {https://doi.org/10.1002/btm2.70195},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Efficacy and safety of a self‐expandable stent‐based endobiliary radiofrequency ablation: A preclinical study
AU - Dong‐Sung Won
AU - Yubeen Park
AU - Ji Won Kim
AU - Jinsu An
AU - Hyung‐Sik Kim
AU - Se‐Chul Lee
AU - Youngjae Lee
AU - Dongwook Oh
AU - Jung‐Hoon Park
PY - 2026
DA - 2026/11/05
JO - Bioengineering & Translational Medicine
DO - 10.1002/btm2.70195
UR - https://doi.org/10.1002/btm2.70195
AB - The temperature‐controlled, bipolar self‐expandable stent (SES)‐based radiofrequency ablation (RFA) system represents a novel endobiliary RFA approach; however, its efficacy and safety must be verified before clinical application. The study aimed to investigate the efficacy and safety of SES–RFA in a porcine common bile duct (CBD) model. Ablation ranges were investigated using ex vivo porcine liver according to radiofrequency energy and time. For the in vivo study, radiofrequency parameters were set at 20 W for a 20‐mm electrode and 25 W for a 25‐mm electrode at 70°C for 120 s. Twelve pigs underwent endoscopic‐guided SES–RFA using either electrode (n = 6 each). Animals were randomly euthanized at 24 h or 2 weeks after SES–RFA (n = 3 per group). The RFA‐treated CBDs were evaluated using cholangiography, cholangioscopy, hematology, histology, and immunohistochemistry. The SES–RFA system was successfully deployed and retrieved through‐the‐scope without device failure. All animals survived until the study endpoint without RFA‐related adverse events, including ductal perforation, contrast leakage, or hematoma. Hepatobiliary levels of alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, and gamma‐glutamyl transferase were significantly higher at 2 weeks than at 24 h post‐SES–RFA (all p< 0.05). Ablation ranges and degree of mucosal damage, including collagen and TUNEL‐positive deposition, were significantly increased at 2 weeks than at 24 h (all p< 0.05). The temperature‐controlled bipolar SES–RFA system effectively and safely produced circumferential coagulative necrosis without ductal perforation in the porcine CBD. The system may be used for managing unresectable malignant biliary obstruction in anatomically challenging regions where conventional RFA is difficult to use.
SN - 2380-6761
ER -