Aldrighetti Luca, Ratti Francesca, Cillo Umberto, Ferrero Alessandro, Ettorre Giuseppe Maria, Guglielmi Alfredo, Giuliante Felice, Calise Fulvio
IRCCS San Raffaele Hospital, Via Olgettina 60, 20132, Milan, Italy.
Policlinico Universitario, Padua, Italy.
Updates Surg. 2017 Sep;69(3):271-283. doi: 10.1007/s13304-017-0489-x. Epub 2017 Aug 31.
The Italian Group of MILS (I Go MILS) prospective registry was established in 2014 with the goals to create a hub for data and projects on a national basis and to promote the diffusion and implementation of MILS programs on a national scale. The primary endpoint of the present study is to give a snapshot of the real diffusion and outcomes of MILS in Italy, while analyzing the role of the registry in the implementation of MILS programs nationwide. The I Go MILS Registry is a prospective and intention-to-treat registry opened to any Italian center performing MILS, without restriction criteria based on number of procedures. The Registry is developed through the eClinical, an electronic platform for the management of clinical trials and is based on 34 clinical variables, regarding indication, intra- and postoperative course. Clinical outcomes and data regarding implementation of MILS activity have been analyzed for the aim of the study. Between November 2014 and June 2017, data from 1678 MILS performed in 48 centers have been collected (mean number of procedures per center 35, range 1-302). 22% of procedures were performed for benign and 78% for malignant disease (HCC constituted the 49.1% and CRLM the 31.2% of malignant tumors). Major liver resections (>3 liver segments), including right and left hepatectomies, trisectionectomies and ALPPS procedures were 10% of the series. Mean blood loss was 200 ± 230 mL Morbidity rate was 20.5% and mortality was 0.3%. 10.4% of cases were converted to open approach. Median length of stay was 5 days. MILS/total resections ratio in 13 experienced centers increased from 14 to 30% after Registry establishment. MILS programs are well established in Italy, with progressive increase both in the number of cases and in the numerosity of centers. The I Go MILS Registry is playing a crucial role in monitoring the development of MILS in the real world on a national basis while giving a significant contribution to the implementation of MILS programs.
意大利微创肝脏手术（MILS）研究小组前瞻性注册登记于2014年设立，旨在在全国范围内创建一个数据和项目中心，并促进MILS项目在全国范围内的推广与实施。本研究的主要终点是呈现MILS在意大利的实际推广情况和结果，同时分析该注册登记在全国范围内MILS项目实施中的作用。意大利微创肝脏手术（I Go MILS）注册登记是一个前瞻性的意向性治疗注册登记，向任何进行MILS的意大利中心开放，不受手术数量的限制标准约束。该注册登记通过eClinical（一个用于管理临床试验的电子平台）开展，基于34个临床变量，涉及适应证、术中和术后过程。为了本研究的目的，对MILS活动实施的临床结果和数据进行了分析。在2014年11月至2017年6月期间，收集了48个中心进行的1678例MILS的数据（每个中心的平均手术数量为35例，范围为1 - 302例）。22%的手术是针对良性疾病进行的，78%是针对恶性疾病进行的（肝细胞癌占恶性肿瘤的49.1%，结直肠癌肝转移占31.2%）。包括左右肝切除术、三段肝切除术和联合肝脏分隔和门静脉结扎的二步肝切除术（ALPPS）手术在内的大肝切除术（>3个肝段）占该系列手术的10%。平均失血量为200±230毫升。发病率为20.5%，死亡率为0.3%。10.4%的病例转为开放手术。中位住院时间为5天。13个经验丰富的中心在注册登记建立后，MILS/总切除术的比例从14%增加到了30%。MILS项目在意大利已得到充分确立，病例数量和中心数量都在逐步增加。意大利微创肝脏手术（I Go MILS）注册登记在全国范围内监测现实世界中MILS的发展方面发挥着关键作用，同时为MILS项目的实施做出了重大贡献。
