Soyama Akihiko, Yoshizumi Tomoharu, Takatsuki Mitsuhisa, Harada Noboru, Toshima Takeo, Ono Shinichiro, Hara Takanobu, Matsushima Hajime, Tanaka Takayuki, Imamura Hajime, Adachi Tomohiko, Hidaka Masaaki, Eguchi Susumu
Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, JP.
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, JP.
Int J Surg Protoc. 2021 Jul 28;25(1):141-146. doi: 10.29337/ijsp.151. eCollection 2021.
Postoperative biliary complications in living donor liver transplantation are often difficult to treat, and if treatment is not successful, the patient's QOL is significantly reduced. The frequency of postoperative biliary complications is reported to be higher than that of deceased donor transplantation. In 2013, Lin et al. reported that while biliary reconstruction has traditionally used a surgical surgical loupe (2.5x-4.5x), biliary reconstruction using a surgical microscope (5x-15x) can reduce the incidence of complications. The objective of this study is to clarify the efficacy of biliary reconstruction using surgical microscope in living donor liver transplantation by a multi-facility, randomized comparative study.
It is an open-label randomized controlled study in which target patients who meet the registration requirements are randomly allocated to a surgical loupe group and a microscopy group after obtaining their consent (Ratio 1:1). The primary endpoint is an incidence of biliary complications (bile leakage and anastomotic biliary stricture) with Clavien-Dindo class III or higher within 52 weeks following surgery. The secondary endpoint is length of time required for biliary reconstruction using a surgical microscope.
This study protocol was approved by the institutional review board of Nagasaki University Hospital (No. 20122102-2). The study is registered in UMIN-CTR as UMIN000042011. Written informed consent will be obtained from all participants. The results will be published in a peer-reviewed journal and will be presented at medical meetings.
Postoperative biliary complications in living donor liver transplantation are often difficult to treat.Lower incidence of biliary complication following biliary reconstruction using a surgical microscope has been reported.Facilities those use a surgical microscope for biliary reconstruction are limited.The first study to investigate the efficacy of surgical microscope for biliary construction in liver transplantation by randomized controlled trial.
活体肝移植术后胆道并发症往往难以治疗，若治疗不成功，患者的生活质量会显著降低。据报道，术后胆道并发症的发生率高于尸体供肝移植。2013年，林等人报告称，传统上胆道重建使用手术放大镜（2.5倍至4.5倍），而使用手术显微镜（5倍至15倍）进行胆道重建可降低并发症的发生率。本研究的目的是通过多机构随机对照研究，阐明在活体肝移植中使用手术显微镜进行胆道重建的疗效。
这是一项开放标签随机对照研究，符合登记要求的目标患者在获得同意后被随机分配到手术放大镜组和显微镜组（比例1:1）。主要终点是术后52周内Clavien-Dindo III级或更高等级的胆道并发症（胆漏和吻合口胆道狭窄）的发生率。次要终点是使用手术显微镜进行胆道重建所需的时间。
本研究方案已获得长崎大学医院机构审查委员会的批准（编号20122102-2）。该研究已在UMIN-CTR注册，注册号为UMIN000042011。将从所有参与者那里获得书面知情同意书。研究结果将发表在同行评审期刊上，并在医学会议上展示。
活体肝移植术后胆道并发症往往难以治疗。据报道，使用手术显微镜进行胆道重建后胆道并发症的发生率较低。使用手术显微镜进行胆道重建的机构有限。第一项通过随机对照试验研究手术显微镜在肝移植中胆道重建疗效的研究。
