Feasibility of balloon-based endobiliary radiofrequency ablation under cholangioscopy guidance in a swine model

Although endobiliary radiofrequency ablation (RFA) has demonstrated considerable potential for the treatment of biliary strictures, conventional catheter RFA has several limitations. This study aimed to evaluate the feasibility of a novel cholangioscopy (CS)-guided balloon-based RFA procedure in vivo using a swine model. CS-guided balloon-RFA was performed under endoscopic retrograde cholangiography guidance at target temperatures of 60 ℃ or 70 ℃, which were maintained for 60 s. We evaluated the technical feasibility, adverse events, and histological effects associated with the procedure. Twelve sites were ablated in seven miniature pigs. The CS-guided balloon-RFA procedure was technically successful in all cases without any hindrance. Mucosal changes could be detected during RFA, and the ablation area was identified on CS. Necropsy was performed in four pigs on the same day as the procedure: the tissue samples showed coagulative necrosis, and the entire internal circumference of the bile duct was uniformly ablated. The mean lengths of the ablation area in the samples ablated at 60 °C and 70 °C were 20.64 and 22.18 mm, respectively, while the mean depths were 3.46 and 5.07 mm, respectively. The other three pigs were reared and euthanized and autopsied 35 days after the procedure. The site to be ablated had replaced the granulation tissue and fibrotic changes. No adverse events were observed in any case. CS-guided balloon-RFA appears to be a promising option for treating biliary strictures. This preliminary study could pave the way for the evaluation of this procedure in future human clinical trials.