Department of Gastroenterology, Aichi Medical University, Nagakute, Aichi, Japan.
Center for Clinical Research and Advance Medicine, Shiga University of Medical Science, Seta Tsukinowa-cho, Otsu, Shiga, Japan.
PLoS One. 2023 Mar 31;18(3):e0283733. doi: 10.1371/journal.pone.0283733. eCollection 2023.
Minimally invasive local treatment could be a good option for the treatment of extrahepatic cholangiocarcinoma (eCCA). This study aimed to evaluate the feasibility of a novel local treatment method, endoscopic biliary ethanol ablation (EA), in vivo using a swine model.
This study utilized a prototype of the newly developed multi-hole balloon catheter. The swine bile duct was ablated using this balloon via the same approach as the conventional endoscopic retrograde cholangiography procedure. The study outcomes included technical success, clinical success, and adverse events associated with endoscopic biliary EA.
Fourteen miniature pigs underwent endoscopic biliary EA. Technical success was achieved for all endoscopic EA procedures without any hindrance. All pigs were reared and followed up for a median 35-day period after the procedure. No change was observed in the bile duct wall in one case, in which sufficient contact was not achieved between the balloon and bile duct wall. Except for this case, stricture formation occurred at the site of ablation, where the epithelium was sloughed and necrosis with denaturation replaced the granulation tissue and fibrotic changes. The median length and depth of the ablation area were 17.05 and 2.21 mm, respectively. No adverse events were observed, except for the formation of bile duct strictures and sequelae associated with strictures.
This preliminary study was the first to report endoscopic biliary EA using a novel multi-hole balloon catheter, which demonstrated technical feasibility and potential for the treatment for eCCA.
微创局部治疗可能是治疗肝外胆管癌（eCCA）的一种很好的选择。本研究旨在使用猪模型评估一种新的局部治疗方法，即内镜下胆道乙醇消融（EA）的可行性。
本研究使用新开发的多孔球囊导管的原型。通过与常规内镜逆行胆管造影术相同的方法，使用该球囊对猪胆管进行消融。研究结果包括内镜下胆道 EA 的技术成功率、临床成功率和相关不良事件。
14 头小型猪接受了内镜下胆道 EA。所有内镜 EA 手术均成功完成，没有任何阻碍。所有猪在手术后平均 35 天被饲养和随访。在一例中，由于球囊与胆管壁之间未达到充分接触，胆管壁没有变化。除了这例之外，在消融部位形成了狭窄，上皮脱落，坏死变性取代了肉芽组织和纤维性变化。消融区域的平均长度和深度分别为 17.05 和 2.21 毫米。除了胆管狭窄的形成和狭窄相关的后遗症外，没有观察到不良事件。
这是首次使用新型多孔球囊导管报告内镜下胆道 EA 的初步研究，该研究证明了技术可行性和治疗 eCCA 的潜力。
