Wu Xiuwen, Ren Jianan, Wang Gefei, Wang Jianzhong, Wang Feng, Fan Yueping, Li Yuanxin, Han Gang, Zhou Yanbing, Song Xiaofei, Quan Bin, Yao Min, Li Jieshou
Department of Surgery, Jinling Hospital, Medical School of Nanjing University, 305 East Zhongshan Road, Nanjing, 210002, China.
Department of General Surgery, The 1st Affiliated Hospital of Gannan Medical College, Ganzhou, China.
Trials. 2015 Oct 7;16:445. doi: 10.1186/s13063-015-0966-9.
The management of an enterocutaneous fistula poses a significant challenge to surgeons and is often associated with a costly hospital stay and long-term discomfort. The use of fibrin glue in the fistula tract has been shown to promote closure of low output enterocutaneous fistulas. Our previous nonrandomized study demonstrated that autologous platelet-rich fibrin glue treatment significantly decreased time to fistula closure and promoted closure rates. However, there are several limitations in the study, which may lead to bias in our conclusion. Thus, a multicenter, randomized, controlled clinical trial is required.
METHODS/DESIGN: The study is designed as a randomized, open-label, three-arm, multicenter study in nine Chinese academic hospitals for evaluating the efficacy and safety of fibrin glue for sealing low-output fistulas. An established number of 171 fistula patients will undergo prospective random assignment to autologous fibrin glue, commercial porcine fibrin sealants or drainage cessation (1:1:1). The primary endpoint is fistula closure time (defined as the interval between the day of enrollment and day of fistula closure) during the 14-day treatment period.
To our knowledge, this is the first study to evaluate the safety and efficacy of both autologous and commercial fibrin glue sealing for patients with low-output volume fistulas.
NCT01828892 . Registration date: April 2013.
肠造口瘘的管理对外科医生来说是一项重大挑战，且常常伴随着高昂的住院费用和长期的不适。已证实，在瘘管通道使用纤维蛋白胶可促进低流量肠造口瘘的闭合。我们之前的非随机研究表明，自体富血小板纤维蛋白胶治疗可显著缩短瘘管闭合时间并提高闭合率。然而，该研究存在若干局限性，可能导致我们的结论出现偏差。因此，需要开展一项多中心、随机、对照临床试验。
方法/设计：本研究设计为一项随机、开放标签、三臂、多中心研究，在九家中国学术医院进行，以评估纤维蛋白胶封闭低流量瘘管的疗效和安全性。既定数量的171例瘘管患者将被前瞻性随机分配至自体纤维蛋白胶组、商用猪纤维蛋白封闭剂组或停止引流组（1:1:1）。主要终点是14天治疗期内的瘘管闭合时间（定义为入组日至瘘管闭合日的间隔）。
据我们所知，这是第一项评估自体和商用纤维蛋白胶封闭对低流量瘘管患者安全性和疗效的研究。
NCT01828892。注册日期：2013年4月。
