Abstract
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.
Highlights
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 this novel cholangioscopy (CS)-guided balloon-RFA procedure in vivo using a swine model
Except for these two cases, mucosal changes during RFA could be detected on CS in all instances, and the ablation area was identified immediately after ablation and the removal of the balloon-RFA catheter
Summary
Endobiliary radiofrequency ablation (RFA) has demonstrated considerable potential for the treatment of biliary strictures, conventional catheter RFA has several limitations. The safety of the procedure is a concern because RFA cannot be performed under direct observation with ultrasound or endoscopic guidance To address these issues, we developed a balloon-based endobiliary RFA (balloon-RFA) system and observed that it could achieve a consistent ablation effect without excessive ablation and could be adapted to various lesions, as reported in an ex vivo s tudy[11,12]. We developed a balloon-based endobiliary RFA (balloon-RFA) system and observed that it could achieve a consistent ablation effect without excessive ablation and could be adapted to various lesions, as reported in an ex vivo s tudy[11,12] Another benefit of balloon-RFA is that it allows for the use of a narrower catheter diameter compared to conventional methods. This study aimed to evaluate the feasibility of this novel cholangioscopy (CS)-guided balloon-RFA procedure in vivo using a swine model
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