Inoue Tadahisa, Masuda Takuya, Koiso Tomoharu, Ibusuki Mayu, Oshima Yusuke, Kato Yuta, Kitano Rena, Kutsumi Hiromu
Department of Gastroenterology, Aichi Medical University, Nagakute, Aichi, Japan.
Research & Development Department, Japan Lifeline Co., Ltd., Toda-shi, Saitama, Japan.
PLoS One. 2025 May 12;20(5):e0322801. doi: 10.1371/journal.pone.0322801. eCollection 2025.
Endobiliary radiofrequency ablation (RF-A) is a promising therapeutic option for bile duct strictures. However, conventional catheter RF-A has several limitations, and its usefulness and application remain debated. This study aimed to examine the feasibility of a novel heated-balloon ablation (HB-A).
A prototype HB-A catheter, along with an assembly created from freshly resected porcine liver and a specific jig, was used in this study. The test HB-A setting was set in six patterns: 70°C in the target temperature with 2.5 min in the target temperature maintenance time, 70°C with 5 min, 75°C with 2.5 min, 75°C with 5 min, 80°C with 2.5 min, and 80°C with 5 min. The study outcomes included the ablation range and temperature propagation associated with HB-A.
The lengths and depths of the ablation area were 15.8 ± 1.3 and 1.5 ± 0.1, 18.0 ± 0.7 and 2.1 ± 0.1, 18.8 ± 0.4 and 2.3 ± 0.2, 18.5 ± 0.9 and 2.5 ± 0.1, 19.8 ± 0.8 and 2.5 ± 0.1, and 20.5 ± 0.5 and 3.4 ± 0.1 mm in 70°C for 2.5 min, 70°C for 5 min, 75°C for 2.5 min, 75°C for 5 min, 80°C for 2.5 min, and 80°C for 5 min, respectively. Excessive ablation was not observed during any procedure. The temperature cutoff for achieving or not achieving the ablation effect was between 55 and 60°C for every setting.
The novel HB-A treatment has good temperature and ablation range control with high reproducibility under the same settings while preventing excessive ablation. This study paves the way for further evaluation of this procedure and its early clinical application.
胆管内射频消融术（RF-A）是治疗胆管狭窄的一种有前景的治疗选择。然而，传统的导管射频消融术有若干局限性，其有效性和应用仍存在争议。本研究旨在探讨新型热球囊消融术（HB-A）的可行性。
本研究使用了一个HB-A导管原型，以及由新鲜切除的猪肝和一个特定夹具制成的组件。测试的HB-A设置有六种模式：目标温度为70°C，目标温度维持时间为2.5分钟；70°C，5分钟；75°C，2.5分钟；75°C，5分钟；80°C，2.5分钟；80°C，5分钟。研究结果包括与HB-A相关的消融范围和温度传播情况。
在70°C持续2.5分钟、70°C持续5分钟、75°C持续2.5分钟、75°C持续5分钟、80°C持续2.5分钟和80°C持续5分钟的情况下，消融区域的长度和深度分别为15.8±1.3和1.5±0.1、18.0±0.7和2.1±0.1、18.8±0.4和2.3±0.2、18.5±0.9和2.5±0.1、19.8±0.8和2.5±0.1、20.5±0.5和3.4±0.1毫米。在任何操作过程中均未观察到过度消融。每种设置下实现或未实现消融效果的温度临界值在55至60°C之间。
新型HB-A治疗在相同设置下具有良好的温度和消融范围控制，可重复性高，同时可防止过度消融。本研究为该手术的进一步评估及其早期临床应用铺平了道路。
