Park Jin-Seok, Jeong Seok, Lee Don Haeng, Kim Joon Mee, Kim Sung Min, Kang Hyun Wook
Department of Internal Medicine, Inha University School of Medicine, Incheon, South Korea.
National Center of Efficacy Evaluation for the Development of Health Products Targeting Digestive Disorders (NCEED), Incheon, South Korea.
Lasers Med Sci. 2021 Feb;36(1):25-31. doi: 10.1007/s10103-020-02992-6. Epub 2020 Mar 10.
Endoscopic management of benign biliary stricture (BBS) remains challenging. Stenting is currently used for BBS management, but refractory BBS remains problematic. The aim of this study was to assess the safety and feasibility of a dilation balloon-equipped cylindrical light diffuser for BBS in a large animal model. A total of seven mini-pigs were used in the current study. Laser settings were chosen based on the findings of a previous animal study. Five animals were used in a preliminary study to establish process conditions. BBSs were created in the common bile ducts of the other two animals by intraductal radiofrequency ablation (RFA) via endoscopic retrograde cholangiography (ERC). At 4 weeks post-RFA, laser ablation was performed using a customized balloon-equipped cylindrical diffuser at 10 W for 10 s while maintaining balloon inflation for 10 s at 5 atm. A follow-up ERC was performed at 4 weeks post-laser ablation and the animals were sacrificed for histologic evaluation. BBS was observed in all animals by ERC at 4 weeks post-RFA. The mean bile duct stricture diameter in the two animals as determined by ERC was 0.8 mm. Laser ablations were performed without technical difficulty and no adverse event was encountered. At 4 weeks post-laser ablation, mean biliary stricture diameter had dilated to 1.6 mm on cholangiographic finding. On histologic examination, inflammatory cell infiltration in lamina propria and dense collagen deposition were observed, but there was no evidence of bile duct perforation. The devised balloon-equipped cylindrical laser light diffuser appears to be safe and feasible for the treatment of BBS. However, further studies and modifications are required before it can be applied clinically as a monotherapy.
良性胆管狭窄（BBS）的内镜治疗仍然具有挑战性。目前，支架置入术用于BBS的治疗，但难治性BBS仍然是个问题。本研究的目的是在大型动物模型中评估配备扩张球囊的圆柱形光扩散器治疗BBS的安全性和可行性。本研究共使用了7只小型猪。根据先前动物研究的结果选择激光参数。5只动物用于初步研究以确定操作条件。通过内镜逆行胆管造影（ERC）经导管射频消融（RFA）在另外两只动物的胆总管中制造BBS。在RFA后4周，使用定制的配备球囊的圆柱形扩散器以10W功率进行10秒的激光消融，同时在5个大气压下保持球囊充气10秒。在激光消融后4周进行随访ERC，并对动物实施安乐死以进行组织学评估。在RFA后4周通过ERC在所有动物中均观察到BBS。通过ERC测定，两只动物的平均胆管狭窄直径为0.8mm。激光消融操作无技术困难，未发生不良事件。在激光消融后4周，胆管造影显示平均胆管狭窄直径已扩张至1.6mm。组织学检查发现，固有层有炎性细胞浸润和致密的胶原沉积，但无胆管穿孔的证据。所设计的配备球囊的圆柱形激光光扩散器似乎对BBS的治疗是安全可行的。然而，在作为单一疗法临床应用之前，还需要进一步的研究和改进。
